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Trial record 94 of 186 for:    GLYCOPYRROLATE

Comparative Study of Error Rates Between ELLIPTA® Dry Powder Inhaler (DPI) and Other DPIs

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ClinicalTrials.gov Identifier: NCT03114969
Recruitment Status : Completed
First Posted : April 14, 2017
Results First Posted : June 10, 2019
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Pulmonary Disease, Chronic Obstructive
Interventions Device: Relvar ELLIPTA
Device: Symbicort TURBUHALER
Device: Seretide DISKUS
Device: Spiriva HANDIHALER
Device: BREEZHALER
Device: Incruse ELLIPTA
Device: Anoro ELLIPTA
Enrollment 450
Recruitment Details This was an open-label study investigating error rates for ELLIPTA dry powder inhaler (DPI), alone or in combination when compared to other DPIs (DISKUS, Turbuhaler, HandiHaler and Breezhaler) and combinations of these, as prescribed to chronic obstructive pulmonary disease (COPD) participants, prior to any retraining in correct use.
Pre-assignment Details A total of 461 participants were screened of which 11 failed screening and 450 participants were enrolled. The study was conducted in two countries-Netherlands and the United Kingdom.
Arm/Group Title Relvar Ellipta Symbicort Turbuhaler Seretide Diskus Spiriva Handihaler Incruse/Anoro Ellipta Ultibro/Seebri Breezhaler Relvar Ellipta+LAMA Symbicort Turbuhaler+LAMA Seretide Diskus+LAMA
Hide Arm/Group Description Participants prescribed a fixed dose combination of inhaled corticosteroid/long-acting beta agonist (ICS/LABA) via Relvar Ellipta for treatment of COPD were included. Participants were assessed for errors while using Relvar Ellipta prior to retraining on the correct use of Ellipta DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Relvar Ellipta within 6 weeks at Visit 2. Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler for treatment of COPD were included. Participants were assessed for errors while using Symbicort Turbuhaler prior to retraining on the correct use of Turbuhaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Symbicort Turbuhaler within 6 weeks at Visit 2. Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus for treatment of COPD were included. Participants were assessed for errors while using Seretide Diskus prior to retraining on the correct use of Diskus at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Seretide Diskus within 6 weeks at Visit 2. Participants prescribed a fixed dose of long-acting muscarinic antagonist (LAMA) via Spiriva Handihaler for treatment of COPD were included. Participants were assessed for errors while using Spiriva Handihaler prior to retraining on the correct use of Handihaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Spiriva Handihaler within 6 weeks at Visit 2. Participants prescribed a fixed dose of LAMA via Incruse Ellipta or participants taking a fixed dose combination of LAMA/LABA via Anoro Ellipta for treatment of COPD were included. Participants were assessed for errors while using Incruse/Anoro Ellipta prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Incruse/Anoro Ellipta within 6 weeks at Visit 2. Participants prescribed a fixed dose of LAMA via Seebri Breezehaler or participants taking a fixed dose combination of LAMA/LABA via a single DPI of Ultibro Breezehaler for treatment of COPD were included. Participants were assessed for errors while using Ultibro/Seebri Breezehaler prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Ultibro/Seebri Breezehaler within 6 weeks at Visit 2. Participants prescribed a fixed dose combination of ICS/LABA via Relvar Ellipta along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2. Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2. Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
Period Title: Overall Study
Started 50 50 50 50 51 49 50 50 50
Completed 50 50 46 48 51 48 49 50 48
Not Completed 0 0 4 2 0 1 1 0 2
Reason Not Completed
Lost to Follow-up             0             0             3             2             0             0             0             0             0
Adverse Event             0             0             1             0             0             1             1             0             2
Arm/Group Title Relvar Ellipta Symbicort Turbuhaler Seretide Diskus Spiriva Handihaler Incruse/Anoro Ellipta Ultibro/Seebri Breezhaler Relvar Ellipta+LAMA Symbicort Turbuhaler+LAMA Seretide Diskus+LAMA Total
Hide Arm/Group Description Participants prescribed a fixed dose combination of inhaled corticosteroid/long-acting beta agonist (ICS/LABA) via Relvar Ellipta for treatment of COPD were included. Participants were assessed for errors while using Relvar Ellipta prior to retraining on the correct use of Ellipta DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Relvar Ellipta within 6 weeks at Visit 2. Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler for treatment of COPD were included. Participants were assessed for errors while using Symbicort Turbuhaler prior to retraining on the correct use of Turbuhaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Symbicort Turbuhaler within 6 weeks at Visit 2. Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus for treatment of COPD were included. Participants were assessed for errors while using Seretide Diskus prior to retraining on the correct use of Diskus at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Seretide Diskus within 6 weeks at Visit 2. Participants prescribed a fixed dose of long-acting muscarinic antagonist (LAMA) via Spiriva Handihaler for treatment of COPD were included. Participants were assessed for errors while using Spiriva Handihaler prior to retraining on the correct use of Handihaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Spiriva Handihaler within 6 weeks at Visit 2. Participants prescribed a fixed dose of LAMA via Incruse Ellipta or participants taking a fixed dose combination of LAMA/LABA via Anoro Ellipta for treatment of COPD were included. Participants were assessed for errors while using Incruse/Anoro Ellipta prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Incruse/Anoro Ellipta within 6 weeks at Visit 2. Participants prescribed a fixed dose of LAMA via Seebri Breezehaler or participants taking a fixed dose combination of LAMA/LABA via a single DPI of Ultibro Breezehaler for treatment of COPD were included. Participants were assessed for errors while using Ultibro/Seebri Breezehaler prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Ultibro/Seebri Breezehaler within 6 weeks at Visit 2. Participants prescribed a fixed dose combination of ICS/LABA via Relvar Ellipta along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2. Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2. Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2. Total of all reporting groups
Overall Number of Baseline Participants 50 50 50 50 51 49 50 50 50 450
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 50 participants 50 participants 50 participants 51 participants 49 participants 50 participants 50 participants 50 participants 450 participants
64.6  (10.24) 65.2  (11.43) 68.7  (10.67) 69.5  (9.95) 66.8  (8.93) 67.7  (10.01) 66.6  (8.44) 67.5  (8.21) 68.1  (9.16) 67.2  (9.75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 50 participants 50 participants 51 participants 49 participants 50 participants 50 participants 50 participants 450 participants
Female
29
  58.0%
26
  52.0%
29
  58.0%
21
  42.0%
24
  47.1%
19
  38.8%
28
  56.0%
18
  36.0%
14
  28.0%
208
  46.2%
Male
21
  42.0%
24
  48.0%
21
  42.0%
29
  58.0%
27
  52.9%
30
  61.2%
22
  44.0%
32
  64.0%
36
  72.0%
242
  53.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 50 participants 50 participants 51 participants 49 participants 50 participants 50 participants 50 participants 450 participants
African American/African Heritage
0
   0.0%
1
   2.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.0%
0
   0.0%
1
   2.0%
0
   0.0%
3
   0.7%
Asian-Central/South Asian Heritage
0
   0.0%
0
   0.0%
4
   8.0%
0
   0.0%
3
   5.9%
1
   2.0%
2
   4.0%
2
   4.0%
3
   6.0%
15
   3.3%
Asian-East Asian Heritage
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.2%
Asian-Japanese Heritage
1
   2.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.2%
Asian-South East Asian Heritage
0
   0.0%
0
   0.0%
1
   2.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.0%
2
   0.4%
White-Arabic/North African Heritage
0
   0.0%
1
   2.0%
4
   8.0%
1
   2.0%
0
   0.0%
0
   0.0%
1
   2.0%
0
   0.0%
0
   0.0%
7
   1.6%
White-White/Caucasian/European Heritage
49
  98.0%
48
  96.0%
41
  82.0%
49
  98.0%
47
  92.2%
47
  95.9%
47
  94.0%
47
  94.0%
46
  92.0%
421
  93.6%
1.Primary Outcome
Title Percentage of Participants Making at Least One Critical Error at Visit 1-Primary Device Comparisons
Hide Description Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the health care practitioner (HCP) in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in patient instruction leaflets (PILs) for the respective DPI. The errors made during demonstration by participants were defined as “critical”, when the participant received a lesser/no dose. The percentage of participants making at least one critical error in the primary DPI is presented. The analysis was performed on the Intent to Treat (ITT) Population which comprised of all enrolled participants who demonstrated use of their primary DPI.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Relvar Ellipta Symbicort Turbuhaler Seretide Diskus Spiriva Handihaler Incruse/Anoro Ellipta Ultibro/Seebri Breezhaler Relvar Ellipta+LAMA Symbicort Turbuhaler+LAMA Seretide Diskus+LAMA
Hide Arm/Group Description:
Participants prescribed a fixed dose combination of inhaled corticosteroid/long-acting beta agonist (ICS/LABA) via Relvar Ellipta for treatment of COPD were included. Participants were assessed for errors while using Relvar Ellipta prior to retraining on the correct use of Ellipta DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Relvar Ellipta within 6 weeks at Visit 2.
Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler for treatment of COPD were included. Participants were assessed for errors while using Symbicort Turbuhaler prior to retraining on the correct use of Turbuhaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Symbicort Turbuhaler within 6 weeks at Visit 2.
Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus for treatment of COPD were included. Participants were assessed for errors while using Seretide Diskus prior to retraining on the correct use of Diskus at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Seretide Diskus within 6 weeks at Visit 2.
Participants prescribed a fixed dose of long-acting muscarinic antagonist (LAMA) via Spiriva Handihaler for treatment of COPD were included. Participants were assessed for errors while using Spiriva Handihaler prior to retraining on the correct use of Handihaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Spiriva Handihaler within 6 weeks at Visit 2.
Participants prescribed a fixed dose of LAMA via Incruse Ellipta or participants taking a fixed dose combination of LAMA/LABA via Anoro Ellipta for treatment of COPD were included. Participants were assessed for errors while using Incruse/Anoro Ellipta prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Incruse/Anoro Ellipta within 6 weeks at Visit 2.
Participants prescribed a fixed dose of LAMA via Seebri Breezehaler or participants taking a fixed dose combination of LAMA/LABA via a single DPI of Ultibro Breezehaler for treatment of COPD were included. Participants were assessed for errors while using Ultibro/Seebri Breezehaler prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Ultibro/Seebri Breezehaler within 6 weeks at Visit 2.
Participants prescribed a fixed dose combination of ICS/LABA via Relvar Ellipta along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
Overall Number of Participants Analyzed 50 50 50 50 51 49 50 50 50
Measure Type: Number
Unit of Measure: Percentage of participants
10 40 26 34 10 33 12 38 26
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta, Symbicort Turbuhaler
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.657
Confidence Interval (2-Sided) 95%
1.584 to 13.686
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta, Seretide Diskus
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.114
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.478
Confidence Interval (2-Sided) 95%
0.805 to 7.632
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Spiriva Handihaler, Incruse/Anoro Ellipta
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.499
Confidence Interval (2-Sided) 95%
1.160 to 10.555
Estimation Comments Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Incruse/Anoro Ellipta, Ultibro/Seebri Breezhaler
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.943
Confidence Interval (2-Sided) 95%
1.348 to 11.534
Estimation Comments Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta, Relvar Ellipta+LAMA
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.746
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.223
Confidence Interval (2-Sided) 95%
0.361 to 4.151
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta, Symbicort Turbuhaler
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.562
Confidence Interval (2-Sided) 95%
1.932 to 16.013
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta, Seretide Diskus
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.050
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.979
Confidence Interval (2-Sided) 95%
0.999 to 8.882
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Spiriva Handihaler, Incruse/Anoro Ellipta
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.418
Confidence Interval (2-Sided) 95%
1.521 to 12.834
Estimation Comments Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Incruse/Anoro Ellipta, Ultibro/Seebri Breezhaler
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.165
Confidence Interval (2-Sided) 95%
1.425 to 12.178
Estimation Comments Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta, Relvar Ellipta+LAMA
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.761
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.209
Confidence Interval (2-Sided) 95%
0.357 to 4.095
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator.
2.Primary Outcome
Title Percentage of Participants Making at Least One Critical Error at Visit 1 in Primary DPI (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI)
Hide Description Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as “critical”, when the participant received a lesser/no dose. The percentage of participants making at least one critical error in the primary DPI is presented. The aim of the analysis was to compare percentage of participants making at least one critical error with Ellipta versus all ICS/LABA+LAMA DPIs; hence, the arms were combined as pre-specified in the protocol and reporting and analysis plan (RAP).
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title [Relvar Ellipta+LAMA]+[Symb Turb+LAMA]+[Seretide Diskus+LAMA] Relvar Ellipta
Hide Arm/Group Description:
All participants from Relvar Ellipta+LAMA, Symbicort Turbuhaler (Symb Turb)+LAMA, and Seretide Diskus+LAMA arms were included.
Participants prescribed a fixed dose combination of inhaled corticosteroid/long-acting beta agonist (ICS/LABA) via Relvar Ellipta for treatment of COPD were included. Participants were assessed for errors while using Relvar Ellipta prior to retraining on the correct use of Ellipta DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Relvar Ellipta within 6 weeks at Visit 2.
Overall Number of Participants Analyzed 150 50
Measure Type: Number
Unit of Measure: Percentage of participants
25 10
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection [Relvar Ellipta+LAMA]+[Symb Turb+LAMA]+[Seretide Diskus+LAMA], Relvar Ellipta
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.100
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.292
Confidence Interval (2-Sided) 95%
0.853 to 6.163
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection [Relvar Ellipta+LAMA]+[Symb Turb+LAMA]+[Seretide Diskus+LAMA], Relvar Ellipta
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.051
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.642
Confidence Interval (2-Sided) 95%
0.994 to 7.022
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator.
3.Primary Outcome
Title Percentage of Participants Making at Least One Critical Error at Visit 1 in Primary DPI (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI
Hide Description Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as “critical”, when the participant received a lesser/no dose. The percentage of participants making at least one critical error in the primary DPI is presented. The aim of the analysis was to compare percentage of participants making at least one critical error with Ellipta and Ellipta+LAMA versus Turbuhaler and Turbuhaler+LAMA and Diskus and Diskus+LAMA; hence, the arms were combined as pre-specified in the protocol and RAP.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Relvar Ellipta+[Relvar Ellipta+LAMA] Symbicort Turbuhaler+[Symbicort Turbuhaler+LAMA] Seretide Diskus+[Seretide Diskus+LAMA]
Hide Arm/Group Description:
All participants from Relvar Ellipta and Relvar Ellipta+LAMA arms were included.
All participants from Symbicort Turbuhaler and Symbicort Turbuhaler+LAMA arms were included.
All participants from Seretide Diskus and Seretide Diskus+LAMA arms were included.
Overall Number of Participants Analyzed 100 100 100
Measure Type: Number
Unit of Measure: Percentage of participants
11 39 26
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta+[Relvar Ellipta+LAMA], Symbicort Turbuhaler+[Symbicort Turbuhaler+LAMA]
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.995
Confidence Interval (2-Sided) 95%
1.808 to 8.829
Estimation Comments Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta+[Relvar Ellipta+LAMA], Seretide Diskus+[Seretide Diskus+LAMA]
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.069
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.181
Confidence Interval (2-Sided) 95%
0.940 to 5.059
Estimation Comments Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta+[Relvar Ellipta+LAMA], Symbicort Turbuhaler+[Symbicort Turbuhaler+LAMA]
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.855
Confidence Interval (2-Sided) 95%
2.339 to 10.080
Estimation Comments Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta+[Relvar Ellipta+LAMA], Seretide Diskus+[Seretide Diskus+LAMA]
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.710
Confidence Interval (2-Sided) 95%
1.274 to 5.764
Estimation Comments Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator.
4.Primary Outcome
Title Percentage of Participants Making at Least One Critical Error at Visit 1-Dual Device Comparisons (Relvar Ellipta DPI Versus Relvar Ellipta With Any Other LAMA)
Hide Description Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as “critical”, when the participant received a lesser/no dose. The percentage of participants making at least one critical error in either one or both devices (where applicable) is presented.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Relvar Ellipta Relvar Ellipta+LAMA
Hide Arm/Group Description:
Participants prescribed a fixed dose combination of inhaled corticosteroid/long-acting beta agonist (ICS/LABA) via Relvar Ellipta for treatment of COPD were included. Participants were assessed for errors while using Relvar Ellipta prior to retraining on the correct use of Ellipta DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Relvar Ellipta within 6 weeks at Visit 2.
Participants prescribed a fixed dose combination of ICS/LABA via Relvar Ellipta along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
Overall Number of Participants Analyzed 50 50
Measure Type: Number
Unit of Measure: Percentage of participants
10 22
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta, Relvar Ellipta+LAMA
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.108
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.503
Confidence Interval (2-Sided) 95%
0.818 to 7.659
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta, Relvar Ellipta+LAMA
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.122
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.409
Confidence Interval (2-Sided) 95%
0.792 to 7.331
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator.
5.Primary Outcome
Title Percentage of Participants Making at Least One Critical Error at Visit 1-Dual Device Comparisons (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI)
Hide Description Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as “critical”, when the participant received a lesser/no dose. The percentage of participants making at least one critical error in either one or both devices (where applicable) is presented. The aim of the analysis was to compare percentage of participants making at least one critical error with Ellipta versus all ICS/LABA+LAMA DPIs; hence, the arms were combined as pre-specified in the protocol and RAP.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Relvar Ellipta [Relvar Ellipta+LAMA]+[Symb Turb+LAMA]+[Seretide Diskus+LAMA]
Hide Arm/Group Description:
Participants prescribed a fixed dose combination of inhaled corticosteroid/long-acting beta agonist (ICS/LABA) via Relvar Ellipta for treatment of COPD were included. Participants were assessed for errors while using Relvar Ellipta prior to retraining on the correct use of Ellipta DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Relvar Ellipta within 6 weeks at Visit 2.
All participants from Relvar Ellipta+LAMA, Symbicort Turbuhaler (Symb Turb)+LAMA, and Seretide Diskus+LAMA arms were included.
Overall Number of Participants Analyzed 50 150
Measure Type: Number
Unit of Measure: Percentage of participants
10 41
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta, [Relvar Ellipta+LAMA]+[Symb Turb+LAMA]+[Seretide Diskus+LAMA]
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.887
Confidence Interval (2-Sided) 95%
1.851 to 12.903
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta, [Relvar Ellipta+LAMA]+[Symb Turb+LAMA]+[Seretide Diskus+LAMA]
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.484
Confidence Interval (2-Sided) 95%
2.106 to 14.284
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator.
6.Primary Outcome
Title Percentage of Participants Making at Least One Critical Error at Visit 1-Dual Device Comparisons (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI)
Hide Description Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as “critical”, when the participant received a lesser/no dose. The percentage of participants making at least one critical error in either one or both devices (where applicable) is presented. The aim of the analysis was to compare percentage of participants making at least one critical error with Ellipta and Ellipta+LAMA versus Turbuhaler and Turbuhaler+LAMA and Diskus and Diskus+LAMA; hence, the arms were combined as pre-specified in the protocol and RAP.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Relvar Ellipta+[Relvar Ellipta+LAMA] Symbicort Turbuhaler+[Symbicort Turbuhaler+LAMA] Seretide Diskus+[Seretide Diskus+LAMA]
Hide Arm/Group Description:
All participants from Relvar Ellipta and Relvar Ellipta+LAMA arms were included.
All participants from Symbicort Turbuhaler and Symbicort Turbuhaler+LAMA arms were included.
All participants from Seretide Diskus and Seretide Diskus+LAMA arms were included.
Overall Number of Participants Analyzed 100 100 100
Measure Type: Number
Unit of Measure: Percentage of participants
16 47 36
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta+[Relvar Ellipta+LAMA], Symbicort Turbuhaler+[Symbicort Turbuhaler+LAMA]
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.941
Confidence Interval (2-Sided) 95%
1.863 to 8.337
Estimation Comments Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta+[Relvar Ellipta+LAMA], Seretide Diskus+[Seretide Diskus+LAMA]
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.030
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.391
Confidence Interval (2-Sided) 95%
1.088 to 5.256
Estimation Comments Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta+[Relvar Ellipta+LAMA], Symbicort Turbuhaler+[Symbicort Turbuhaler+LAMA]
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.728
Confidence Interval (2-Sided) 95%
2.388 to 9.364
Estimation Comments Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta+[Relvar Ellipta+LAMA], Seretide Diskus+[Seretide Diskus+LAMA]
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.957
Confidence Interval (2-Sided) 95%
1.473 to 5.936
Estimation Comments Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator.
7.Secondary Outcome
Title Percentage of Participants Making at Least One Overall Error at Visit 1-Primary Device Comparisons
Hide Description Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as “critical”, when the participant received a lesser/no dose and non-critical when the dose may not be affected, but the participant has demonstrated improper use of their DPI, as per the PIL. Overall errors is the combination of critical and non-critical errors. The percentage of participants with at least one overall error in the primary DPI is presented.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Relvar Ellipta Symbicort Turbuhaler Seretide Diskus Spiriva Handihaler Incruse/Anoro Ellipta Ultibro/Seebri Breezhaler Relvar Ellipta+LAMA Symbicort Turbuhaler+LAMA Seretide Diskus+LAMA
Hide Arm/Group Description:
Participants prescribed a fixed dose combination of inhaled corticosteroid/long-acting beta agonist (ICS/LABA) via Relvar Ellipta for treatment of COPD were included. Participants were assessed for errors while using Relvar Ellipta prior to retraining on the correct use of Ellipta DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Relvar Ellipta within 6 weeks at Visit 2.
Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler for treatment of COPD were included. Participants were assessed for errors while using Symbicort Turbuhaler prior to retraining on the correct use of Turbuhaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Symbicort Turbuhaler within 6 weeks at Visit 2.
Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus for treatment of COPD were included. Participants were assessed for errors while using Seretide Diskus prior to retraining on the correct use of Diskus at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Seretide Diskus within 6 weeks at Visit 2.
Participants prescribed a fixed dose of long-acting muscarinic antagonist (LAMA) via Spiriva Handihaler for treatment of COPD were included. Participants were assessed for errors while using Spiriva Handihaler prior to retraining on the correct use of Handihaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Spiriva Handihaler within 6 weeks at Visit 2.
Participants prescribed a fixed dose of LAMA via Incruse Ellipta or participants taking a fixed dose combination of LAMA/LABA via Anoro Ellipta for treatment of COPD were included. Participants were assessed for errors while using Incruse/Anoro Ellipta prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Incruse/Anoro Ellipta within 6 weeks at Visit 2.
Participants prescribed a fixed dose of LAMA via Seebri Breezehaler or participants taking a fixed dose combination of LAMA/LABA via a single DPI of Ultibro Breezehaler for treatment of COPD were included. Participants were assessed for errors while using Ultibro/Seebri Breezehaler prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Ultibro/Seebri Breezehaler within 6 weeks at Visit 2.
Participants prescribed a fixed dose combination of ICS/LABA via Relvar Ellipta along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
Overall Number of Participants Analyzed 50 50 50 50 51 49 50 50 50
Measure Type: Number
Unit of Measure: Percentage of participants
34 64 60 74 37 55 34 70 66
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta, Symbicort Turbuhaler
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.045
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.404
Confidence Interval (2-Sided) 95%
1.018 to 5.676
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta, Seretide Diskus
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.172
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.823
Confidence Interval (2-Sided) 95%
0.770 to 4.319
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Spiriva Handihaler, Incruse/Anoro Ellipta
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.989
Confidence Interval (2-Sided) 95%
1.229 to 7.272
Estimation Comments Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Incruse/Anoro Ellipta, Ultibro/Seebri Breezhaler
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.179
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.747
Confidence Interval (2-Sided) 95%
0.775 to 3.937
Estimation Comments Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta, Relvar Ellipta+LAMA
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.690
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.189
Confidence Interval (2-Sided) 95%
0.509 to 2.775
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta, Symbicort Turbuhaler
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.363
Confidence Interval (2-Sided) 95%
1.480 to 7.639
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta, Seretide Diskus
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.848
Confidence Interval (2-Sided) 95%
1.264 to 6.420
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Spiriva Handihaler, Incruse/Anoro Ellipta
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.630
Confidence Interval (2-Sided) 95%
1.986 to 10.791
Estimation Comments Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Incruse/Anoro Ellipta, Ultibro/Seebri Breezhaler
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.081
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.037
Confidence Interval (2-Sided) 95%
0.916 to 4.528
Estimation Comments Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta, Relvar Ellipta+LAMA
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.000
Confidence Interval (2-Sided) 95%
0.438 to 2.283
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator.
8.Secondary Outcome
Title Percentage of Participants Making at Least One Overall Error at Visit 1 in Primary DPI (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI)
Hide Description Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as “critical”, when the participant received a lesser/no dose and non-critical when the dose may not be affected, but the participant has demonstrated improper use of their DPI, as per the PIL. Overall errors is the combination of critical and non-critical errors. The percentage of participants with at least one overall error in primary DPI is presented. The aim of the analysis was to compare percentage of participants making at least one overall error with Ellipta versus all ICS/LABA+LAMA DPIs; hence, the arms were combined as pre-specified in the protocol and RAP.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title [Relvar Ellipta+LAMA]+[Symb Turb+LAMA]+[Seretide Diskus+LAMA] Relvar Ellipta
Hide Arm/Group Description:
All participants from Relvar Ellipta+LAMA, Symbicort Turbuhaler (Symb Turb)+LAMA, and Seretide Diskus+LAMA arms were included.
Participants prescribed a fixed dose combination of inhaled corticosteroid/long-acting beta agonist (ICS/LABA) via Relvar Ellipta for treatment of COPD were included. Participants were assessed for errors while using Relvar Ellipta prior to retraining on the correct use of Ellipta DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Relvar Ellipta within 6 weeks at Visit 2.
Overall Number of Participants Analyzed 150 50
Measure Type: Number
Unit of Measure: Percentage of participants
57 34
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection [Relvar Ellipta+LAMA]+[Symb Turb+LAMA]+[Seretide Diskus+LAMA], Relvar Ellipta
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.067
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.935
Confidence Interval (2-Sided) 95%
0.955 to 3.921
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection [Relvar Ellipta+LAMA]+[Symb Turb+LAMA]+[Seretide Diskus+LAMA], Relvar Ellipta
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.523
Confidence Interval (2-Sided) 95%
1.283 to 4.961
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator.
9.Secondary Outcome
Title Percentage of Participants Making at Least One Overall Error at Visit 1 in Primary DPI (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI
Hide Description Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as “critical”, when the participant received a lesser/no dose and non-critical when the dose may not be affected, but the participant has demonstrated improper use of their DPI, as per the PIL. Overall errors is the combination of critical and non-critical errors. The percentage of participants with at least one overall error in primary DPI is presented. The aim of the analysis was to compare percentage of participants making at least one overall error with Ellipta and Ellipta+LAMA versus Turbuhaler and Turbuhaler+LAMA and Diskus and Diskus+LAMA; hence, the arms were combined as pre-specified in the protocol and RAP.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Relvar Ellipta+[Relvar Ellipta+LAMA] Symbicort Turbuhaler+[Symbicort Turbuhaler+LAMA] Seretide Diskus+[Seretide Diskus+LAMA]
Hide Arm/Group Description:
All participants from Relvar Ellipta and Relvar Ellipta+LAMA arms were included.
All participants from Symbicort Turbuhaler and Symbicort Turbuhaler+LAMA arms were included.
All participants from Seretide Diskus and Seretide Diskus+LAMA arms were included.
Overall Number of Participants Analyzed 100 100 100
Measure Type: Number
Unit of Measure: Percentage of participants
34 67 63
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta+[Relvar Ellipta+LAMA], Symbicort Turbuhaler+[Symbicort Turbuhaler+LAMA]
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.399
Confidence Interval (2-Sided) 95%
1.252 to 4.596
Estimation Comments Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta+[Relvar Ellipta+LAMA], Seretide Diskus+[Seretide Diskus+LAMA]
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.082
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.812
Confidence Interval (2-Sided) 95%
0.926 to 3.544
Estimation Comments Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta+[Relvar Ellipta+LAMA], Symbicort Turbuhaler+[Symbicort Turbuhaler+LAMA]
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.840
Confidence Interval (2-Sided) 95%
2.135 to 6.905
Estimation Comments Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta+[Relvar Ellipta+LAMA], Seretide Diskus+[Seretide Diskus+LAMA]
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.231
Confidence Interval (2-Sided) 95%
1.810 to 5.766
Estimation Comments Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator.
10.Secondary Outcome
Title Percentage of Participants Making at Least One Overall Error at Visit 1-Dual Device Comparisons (Relvar Ellipta DPI Versus Relvar Ellipta With Any Other LAMA)
Hide Description Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as “critical”, when the participant received a lesser/no dose and non-critical when the dose may not be affected, but the participant has demonstrated improper use of their DPI, as per the PIL. Overall errors is the combination of critical and non-critical errors. The percentage of participants making at least one overall error in either one or both devices (where applicable) is presented.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Relvar Ellipta Relvar Ellipta+LAMA
Hide Arm/Group Description:
Participants prescribed a fixed dose combination of inhaled corticosteroid/long-acting beta agonist (ICS/LABA) via Relvar Ellipta for treatment of COPD were included. Participants were assessed for errors while using Relvar Ellipta prior to retraining on the correct use of Ellipta DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Relvar Ellipta within 6 weeks at Visit 2.
Participants prescribed a fixed dose combination of ICS/LABA via Relvar Ellipta along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
Overall Number of Participants Analyzed 50 50
Measure Type: Number
Unit of Measure: Percentage of participants
34 46
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta, Relvar Ellipta+LAMA
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.120
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.931
Confidence Interval (2-Sided) 95%
0.842 to 4.428
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta, Relvar Ellipta+LAMA
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.232
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.636
Confidence Interval (2-Sided) 95%
0.730 to 3.664
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator.
11.Secondary Outcome
Title Percentage of Participants Making at Least One Overall Error at Visit 1-Dual Device Comparisons (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI)
Hide Description Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. Errors made during demonstration by participants were defined as “critical”, when the participant received a lesser/no dose and non-critical when the dose may not be affected, but the participant has demonstrated improper use of their DPI, as per the PIL. Overall errors is the combination of critical and non-critical errors. Percentage of participants making at least one overall error in either one or both devices (where applicable) is presented. The aim of the analysis was to compare percentage of participants making at least one overall error with Ellipta versus all ICS/LABA+LAMA DPIs; hence, the arms were combined as pre-specified in the protocol and RAP.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Relvar Ellipta [Relvar Ellipta+LAMA]+[Symb Turb+LAMA]+[Seretide Diskus+LAMA]
Hide Arm/Group Description:
Participants prescribed a fixed dose combination of inhaled corticosteroid/long-acting beta agonist (ICS/LABA) via Relvar Ellipta for treatment of COPD were included. Participants were assessed for errors while using Relvar Ellipta prior to retraining on the correct use of Ellipta DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Relvar Ellipta within 6 weeks at Visit 2.
All participants from Relvar Ellipta+LAMA, Symbicort Turbuhaler (Symb Turb)+LAMA, and Seretide Diskus+LAMA arms were included.
Overall Number of Participants Analyzed 50 150
Measure Type: Number
Unit of Measure: Percentage of participants
34 71
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta, [Relvar Ellipta+LAMA]+[Symb Turb+LAMA]+[Seretide Diskus+LAMA]
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.217
Confidence Interval (2-Sided) 95%
2.019 to 8.807
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta, [Relvar Ellipta+LAMA]+[Symb Turb+LAMA]+[Seretide Diskus+LAMA]
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.410
Confidence Interval (2-Sided) 95%
2.660 to 11.005
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator.
12.Secondary Outcome
Title Percentage of Participants Making at Least One Overall Error at Visit 1-Dual Device Comparisons (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI)
Hide Description Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. Errors made during demonstration by participants were defined as “critical”, when the participant received a lesser/no dose and non-critical when the dose may not be affected, but the participant has demonstrated improper use of their DPI, as per the PIL. Overall errors is the combination of critical and non-critical errors. Percentage of participants making at least one overall error in either one or both devices (where applicable) is presented.The aim of the analysis was to compare percentage of participants making at least one overall error with Ellipta and Ellipta+LAMA versus Turbuhaler and Turbuhaler+LAMA and Diskus and Diskus+LAMA; hence, the arms were combined as pre-specified in the protocol and RAP.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Relvar Ellipta+[Relvar Ellipta+LAMA] Symbicort Turbuhaler+[Symbicort Turbuhaler+LAMA] Seretide Diskus+[Seretide Diskus+LAMA]
Hide Arm/Group Description:
All participants from Relvar Ellipta and Relvar Ellipta+LAMA arms were included.
All participants from Symbicort Turbuhaler and Symbicort Turbuhaler+LAMA arms were included.
All participants from Seretide Diskus and Seretide Diskus+LAMA arms were included.
Overall Number of Participants Analyzed 100 100 100
Measure Type: Number
Unit of Measure: Percentage of participants
40 72 74
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta+[Relvar Ellipta+LAMA], Symbicort Turbuhaler+[Symbicort Turbuhaler+LAMA]
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.477
Confidence Interval (2-Sided) 95%
1.274 to 4.815
Estimation Comments Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta+[Relvar Ellipta+LAMA], Seretide Diskus+[Seretide Diskus+LAMA]
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.748
Confidence Interval (2-Sided) 95%
1.328 to 5.683
Estimation Comments Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta+[Relvar Ellipta+LAMA], Symbicort Turbuhaler+[Symbicort Turbuhaler+LAMA]
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.896
Confidence Interval (2-Sided) 95%
2.133 to 7.118
Estimation Comments Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta+[Relvar Ellipta+LAMA], Seretide Diskus+[Seretide Diskus+LAMA]
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.777
Confidence Interval (2-Sided) 95%
2.508 to 9.100
Estimation Comments Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator.
13.Secondary Outcome
Title Percentage of Participants Making at Least One Critical Error at Visit 2-Primary Device Comparisons
Hide Description Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. Any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as “critical”, when the participant received a lesser/no dose. The percentage of participants making at least one critical error in the primary DPI is presented.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants with data available at Visit 2 were analyzed.
Arm/Group Title Relvar Ellipta Symbicort Turbuhaler Seretide Diskus Spiriva Handihaler Incruse/Anoro Ellipta Ultibro/Seebri Breezhaler Relvar Ellipta+LAMA Symbicort Turbuhaler+LAMA Seretide Diskus+LAMA
Hide Arm/Group Description:
Participants prescribed a fixed dose combination of inhaled corticosteroid/long-acting beta agonist (ICS/LABA) via Relvar Ellipta for treatment of COPD were included. Participants were assessed for errors while using Relvar Ellipta prior to retraining on the correct use of Ellipta DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Relvar Ellipta within 6 weeks at Visit 2.
Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler for treatment of COPD were included. Participants were assessed for errors while using Symbicort Turbuhaler prior to retraining on the correct use of Turbuhaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Symbicort Turbuhaler within 6 weeks at Visit 2.
Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus for treatment of COPD were included. Participants were assessed for errors while using Seretide Diskus prior to retraining on the correct use of Diskus at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Seretide Diskus within 6 weeks at Visit 2.
Participants prescribed a fixed dose of long-acting muscarinic antagonist (LAMA) via Spiriva Handihaler for treatment of COPD were included. Participants were assessed for errors while using Spiriva Handihaler prior to retraining on the correct use of Handihaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Spiriva Handihaler within 6 weeks at Visit 2.
Participants prescribed a fixed dose of LAMA via Incruse Ellipta or participants taking a fixed dose combination of LAMA/LABA via Anoro Ellipta for treatment of COPD were included. Participants were assessed for errors while using Incruse/Anoro Ellipta prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Incruse/Anoro Ellipta within 6 weeks at Visit 2.
Participants prescribed a fixed dose of LAMA via Seebri Breezehaler or participants taking a fixed dose combination of LAMA/LABA via a single DPI of Ultibro Breezehaler for treatment of COPD were included. Participants were assessed for errors while using Ultibro/Seebri Breezehaler prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Ultibro/Seebri Breezehaler within 6 weeks at Visit 2.
Participants prescribed a fixed dose combination of ICS/LABA via Relvar Ellipta along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
Overall Number of Participants Analyzed 50 48 45 47 50 47 49 49 46
Measure Type: Number
Unit of Measure: Percentage of participants
0 8 11 21 0 17 6 6 13
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta, Symbicort Turbuhaler
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.176
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 7.347
Confidence Interval (2-Sided) 95%
0.408 to 132.143
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta, Seretide Diskus
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.128
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 9.300
Confidence Interval (2-Sided) 95%
0.526 to 164.465
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Spiriva Handihaler, Incruse/Anoro Ellipta
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.038
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 20.454
Confidence Interval (2-Sided) 95%
1.190 to 351.613
Estimation Comments Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Incruse/Anoro Ellipta, Ultibro/Seebri Breezhaler
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.041
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 18.776
Confidence Interval (2-Sided) 95%
1.131 to 311.669
Estimation Comments Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta, Relvar Ellipta+LAMA
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.141
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 8.873
Confidence Interval (2-Sided) 95%
0.484 to 162.775
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta, Symbicort Turbuhaler
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.126
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 10.215
Confidence Interval (2-Sided) 95%
0.519 to 200.904
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta, Seretide Diskus
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.082
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 13.717
Confidence Interval (2-Sided) 95%
0.715 to 263.125
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Spiriva Handihaler, Incruse/Anoro Ellipta
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.024
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 28.283
Confidence Interval (2-Sided) 95%
1.561 to 512.532
Estimation Comments Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Incruse/Anoro Ellipta, Ultibro/Seebri Breezhaler
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.038
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 21.736
Confidence Interval (2-Sided) 95%
1.183 to 399.541
Estimation Comments Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta, Relvar Ellipta+LAMA
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.188
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 7.603
Confidence Interval (2-Sided) 95%
0.371 to 155.763
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
14.Secondary Outcome
Title Percentage of Participants Making at Least One Critical Error at Visit 2 in Primary DPI (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI)
Hide Description Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. Any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as “critical”, when the participant received a lesser/no dose. The percentage of participants making at least one critical error in the primary DPI is presented. The aim of the analysis was to compare percentage of participants making at least one critical error with Ellipta versus all ICS/LABA+LAMA DPIs; hence, the arms were combined as pre-specified in the protocol and RAP.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants with data available at Visit 2 were analyzed.
Arm/Group Title [Relvar Ellipta+LAMA]+[Symb Turb+LAMA]+[Seretide Diskus+LAMA] Relvar Ellipta
Hide Arm/Group Description:
All participants from Relvar Ellipta+LAMA, Symbicort Turbuhaler (Symb Turb)+LAMA, and Seretide Diskus+LAMA arms were included.
Participants prescribed a fixed dose combination of inhaled corticosteroid/long-acting beta agonist (ICS/LABA) via Relvar Ellipta for treatment of COPD were included. Participants were assessed for errors while using Relvar Ellipta prior to retraining on the correct use of Ellipta DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Relvar Ellipta within 6 weeks at Visit 2.
Overall Number of Participants Analyzed 144 50
Measure Type: Number
Unit of Measure: Percentage of participants
8 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection [Relvar Ellipta+LAMA]+[Symb Turb+LAMA]+[Seretide Diskus+LAMA], Relvar Ellipta
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.147
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 7.781
Confidence Interval (2-Sided) 95%
0.488 to 124.117
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection [Relvar Ellipta+LAMA]+[Symb Turb+LAMA]+[Seretide Diskus+LAMA], Relvar Ellipta
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.120
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 9.786
Confidence Interval (2-Sided) 95%
0.553 to 173.301
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
15.Secondary Outcome
Title Percentage of Participants Making at Least One Critical Error at Visit 2 in Primary DPI (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI
Hide Description Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. Any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors during demonstration by participants were defined as “critical”, when the participant received a lesser/no dose. The percentage of participants making at least one critical error in the primary DPI is presented. The aim of the analysis was to compare percentage of participants making at least one critical error with Ellipta and Ellipta+LAMA versus Turbuhaler and Turbuhaler+LAMA and Diskus and Diskus+LAMA; hence, the arms were combined as pre-specified in the protocol and RAP.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants with data available at Visit 2 were analyzed.
Arm/Group Title Relvar Ellipta+[Relvar Ellipta+LAMA] Symbicort Turbuhaler+[Symbicort Turbuhaler+LAMA] Seretide Diskus+[Seretide Diskus+LAMA]
Hide Arm/Group Description:
All participants from Relvar Ellipta and Relvar Ellipta+LAMA arms were included.
All participants from Symbicort Turbuhaler and Symbicort Turbuhaler+LAMA arms were included.
All participants from Seretide Diskus and Seretide Diskus+LAMA arms were included.
Overall Number of Participants Analyzed 99 97 91
Measure Type: Number
Unit of Measure: Percentage of participants
3 7 12
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta+[Relvar Ellipta+LAMA], Symbicort Turbuhaler+[Symbicort Turbuhaler+LAMA]
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.395
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.089
Confidence Interval (2-Sided) 95%
0.383 to 11.389
Estimation Comments Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta+[Relvar Ellipta+LAMA], Seretide Diskus+[Seretide Diskus+LAMA]
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.166
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.250
Confidence Interval (2-Sided) 95%
0.612 to 17.244
Estimation Comments Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta+[Relvar Ellipta+LAMA], Symbicort Turbuhaler+[Symbicort Turbuhaler+LAMA]
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.175
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.196
Confidence Interval (2-Sided) 95%
0.596 to 17.140
Estimation Comments Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta+[Relvar Ellipta+LAMA], Seretide Diskus+[Seretide Diskus+LAMA]
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.042
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.408
Confidence Interval (2-Sided) 95%
1.059 to 27.610
Estimation Comments Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
16.Secondary Outcome
Title Percentage of Participants Making at Least One Critical Error at Visit 2-Dual Device Comparisons (Relvar Ellipta DPI Versus Relvar Ellipta With Any Other LAMA)
Hide Description Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. Any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as “critical”, when the participant received a lesser/no dose. The percentage of participants making at least one critical error in either one or both devices (where applicable) is presented.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants with data available at Visit 2 were analyzed.
Arm/Group Title Relvar Ellipta Relvar Ellipta+LAMA
Hide Arm/Group Description:
Participants prescribed a fixed dose combination of inhaled corticosteroid/long-acting beta agonist (ICS/LABA) via Relvar Ellipta for treatment of COPD were included. Participants were assessed for errors while using Relvar Ellipta prior to retraining on the correct use of Ellipta DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Relvar Ellipta within 6 weeks at Visit 2.
Participants prescribed a fixed dose combination of ICS/LABA via Relvar Ellipta along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
Overall Number of Participants Analyzed 50 49
Measure Type: Number
Unit of Measure: Percentage of participants
0 8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta, Relvar Ellipta+LAMA
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.090
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 12.145
Confidence Interval (2-Sided) 95%
0.680 to 216.818
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta, Relvar Ellipta+LAMA
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.130
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 9.991
Confidence Interval (2-Sided) 95%
0.508 to 196.435
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
17.Secondary Outcome
Title Percentage of Participants Making at Least One Critical Error at Visit 2-Dual Device Comparisons (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI)
Hide Description Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. Any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as “critical”, when the participant received a lesser/no dose. The percentage of participants making at least one critical error in either one or both devices (where applicable) is presented. The aim of the analysis was to compare percentage of participants making at least one critical error with Ellipta versus all ICS/LABA+LAMA DPIs; hence, the arms were combined as pre-specified in the protocol and RAP.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants with data available at Visit 2 were analyzed.
Arm/Group Title Relvar Ellipta [Relvar Ellipta+LAMA]+[Symb Turb+LAMA]+[Seretide Diskus+LAMA]
Hide Arm/Group Description:
Participants prescribed a fixed dose combination of inhaled corticosteroid/long-acting beta agonist (ICS/LABA) via Relvar Ellipta for treatment of COPD were included. Participants were assessed for errors while using Relvar Ellipta prior to retraining on the correct use of Ellipta DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Relvar Ellipta within 6 weeks at Visit 2.
All participants from Relvar Ellipta+LAMA, Symbicort Turbuhaler (Symb Turb)+LAMA, and Seretide Diskus+LAMA arms were included.
Overall Number of Participants Analyzed 50 144
Measure Type: Number
Unit of Measure: Percentage of participants
0 13
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta, [Relvar Ellipta+LAMA]+[Symb Turb+LAMA]+[Seretide Diskus+LAMA]
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.079
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 11.907
Confidence Interval (2-Sided) 95%
0.753 to 188.208
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta, [Relvar Ellipta+LAMA]+[Symb Turb+LAMA]+[Seretide Diskus+LAMA]
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.063
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 15.060
Confidence Interval (2-Sided) 95%
0.866 to 262.042
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
18.Secondary Outcome
Title Percentage of Participants Making at Least One Critical Error at Visit 2-Dual Device Comparisons (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI)
Hide Description Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. Any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as “critical”, when the participant received a lesser/no dose. The percentage of participants making at least one critical error in either one or both devices (where applicable) is presented. The aim of the analysis was to compare percentage of participants making at least one critical error with Ellipta and Ellipta+LAMA versus Turbuhaler and Turbuhaler+LAMA and Diskus and Diskus+LAMA; hence, the arms were combined as pre-specified in the protocol and RAP.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants with data available at Visit 2 were analyzed.
Arm/Group Title Relvar Ellipta+[Relvar Ellipta+LAMA] Symbicort Turbuhaler+[Symbicort Turbuhaler+LAMA] Seretide Diskus+[Seretide Diskus+LAMA]
Hide Arm/Group Description:
All participants from Relvar Ellipta and Relvar Ellipta+LAMA arms were included.
All participants from Symbicort Turbuhaler and Symbicort Turbuhaler+LAMA arms were included.
All participants from Seretide Diskus and Seretide Diskus+LAMA arms were included.
Overall Number of Participants Analyzed 99 97 91
Measure Type: Number
Unit of Measure: Percentage of participants
4 11 13
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta+[Relvar Ellipta+LAMA], Symbicort Turbuhaler+[Symbicort Turbuhaler+LAMA]
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.239
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.670
Confidence Interval (2-Sided) 95%
0.521 to 13.690
Estimation Comments Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta+[Relvar Ellipta+LAMA], Seretide Diskus+[Seretide Diskus+LAMA]
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.200
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.929
Confidence Interval (2-Sided) 95%
0.567 to 15.125
Estimation Comments Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta+[Relvar Ellipta+LAMA], Symbicort Turbuhaler+[Symbicort Turbuhaler+LAMA]
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.078
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.269
Confidence Interval (2-Sided) 95%
0.848 to 21.489
Estimation Comments Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta+[Relvar Ellipta+LAMA], Seretide Diskus+[Seretide Diskus+LAMA]
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.046
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.132
Confidence Interval (2-Sided) 95%
1.031 to 25.550
Estimation Comments Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
19.Secondary Outcome
Title Percentage of Participants Making at Least One Overall Error at Visit 2-Primary Device Comparisons
Hide Description Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. Any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as “critical”, when the participant received a lesser/no dose and non-critical when the dose may not be affected, but the participant has demonstrated improper use of their DPI, as per the PIL. Overall errors is the combination of critical and non-critical errors. The percentage of participants making at least one overall error in the primary DPI is presented.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants with data available at Visit 2 were analyzed.
Arm/Group Title Relvar Ellipta Symbicort Turbuhaler Seretide Diskus Spiriva Handihaler Incruse/Anoro Ellipta Ultibro/Seebri Breezhaler Relvar Ellipta+LAMA Symbicort Turbuhaler+LAMA Seretide Diskus+LAMA
Hide Arm/Group Description:
Participants prescribed a fixed dose combination of inhaled corticosteroid/long-acting beta agonist (ICS/LABA) via Relvar Ellipta for treatment of COPD were included. Participants were assessed for errors while using Relvar Ellipta prior to retraining on the correct use of Ellipta DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Relvar Ellipta within 6 weeks at Visit 2.
Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler for treatment of COPD were included. Participants were assessed for errors while using Symbicort Turbuhaler prior to retraining on the correct use of Turbuhaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Symbicort Turbuhaler within 6 weeks at Visit 2.
Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus for treatment of COPD were included. Participants were assessed for errors while using Seretide Diskus prior to retraining on the correct use of Diskus at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Seretide Diskus within 6 weeks at Visit 2.
Participants prescribed a fixed dose of long-acting muscarinic antagonist (LAMA) via Spiriva Handihaler for treatment of COPD were included. Participants were assessed for errors while using Spiriva Handihaler prior to retraining on the correct use of Handihaler at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Spiriva Handihaler within 6 weeks at Visit 2.
Participants prescribed a fixed dose of LAMA via Incruse Ellipta or participants taking a fixed dose combination of LAMA/LABA via Anoro Ellipta for treatment of COPD were included. Participants were assessed for errors while using Incruse/Anoro Ellipta prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Incruse/Anoro Ellipta within 6 weeks at Visit 2.
Participants prescribed a fixed dose of LAMA via Seebri Breezehaler or participants taking a fixed dose combination of LAMA/LABA via a single DPI of Ultibro Breezehaler for treatment of COPD were included. Participants were assessed for errors while using Ultibro/Seebri Breezehaler prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Ultibro/Seebri Breezehaler within 6 weeks at Visit 2.
Participants prescribed a fixed dose combination of ICS/LABA via Relvar Ellipta along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
Participants prescribed a fixed dose combination of ICS/LABA via Symbicort Turbuhaler along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
Participants prescribed a fixed dose combination of ICS/LABA via Seretide Diskus along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
Overall Number of Participants Analyzed 50 48 45 47 50 47 49 49 46
Measure Type: Number
Unit of Measure: Percentage of participants
12 35 27 36 8 32 14 14 28
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta, Symbicort Turbuhaler
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.020
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.483
Confidence Interval (2-Sided) 95%
1.218 to 9.961
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta, Seretide Diskus
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.143
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.284
Confidence Interval (2-Sided) 95%
0.757 to 6.895
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Spiriva Handihaler, Incruse/Anoro Ellipta
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.268
Confidence Interval (2-Sided) 95%
1.615 to 17.187
Estimation Comments Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Incruse/Anoro Ellipta, Ultibro/Seebri Breezhaler
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.655
Confidence Interval (2-Sided) 95%
1.478 to 14.666
Estimation Comments Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta, Relvar Ellipta+LAMA
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.679
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.274
Confidence Interval (2-Sided) 95%
0.405 to 4.005
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta, Symbicort Turbuhaler
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.804
Confidence Interval (2-Sided) 95%
1.372 to 10.544
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta, Seretide Diskus
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.083
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.555
Confidence Interval (2-Sided) 95%
0.886 to 7.369
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Spiriva Handihaler, Incruse/Anoro Ellipta
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.930
Confidence Interval (2-Sided) 95%
1.890 to 18.611
Estimation Comments Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Incruse/Anoro Ellipta, Ultibro/Seebri Breezhaler
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.929
Confidence Interval (2-Sided) 95%
1.556 to 15.612
Estimation Comments Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta, Relvar Ellipta+LAMA
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.746
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.208
Confidence Interval (2-Sided) 95%
0.385 to 3.788
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
20.Secondary Outcome
Title Percentage of Participants Making at Least One Overall Error at Visit 2 in Primary DPI (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI)
Hide Description Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. Any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps listed in PILs for the respective DPI. The errors were defined as “critical”, when the participant received a lesser/no dose and non-critical when the dose may not be affected, but the participant has demonstrated improper use of their DPI, as per PIL. Overall errors is the combination of critical and non-critical errors. The percentage of participants making at least one overall error in primary DPI is presented. The aim of the analysis was to compare percentage of participants making at least one overall error with Ellipta versus all ICS/LABA+LAMA DPIs; hence, the arms were combined as pre-specified in the protocol and RAP.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants with data available at Visit 2 were analyzed.
Arm/Group Title [Relvar Ellipta+LAMA]+[Symb Turb+LAMA]+[Seretide Diskus+LAMA] Relvar Ellipta
Hide Arm/Group Description:
All participants from Relvar Ellipta+LAMA, Symbicort Turbuhaler (Symb Turb)+LAMA, and Seretide Diskus+LAMA arms were included.
Participants prescribed a fixed dose combination of inhaled corticosteroid/long-acting beta agonist (ICS/LABA) via Relvar Ellipta for treatment of COPD were included. Participants were assessed for errors while using Relvar Ellipta prior to retraining on the correct use of Ellipta DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Relvar Ellipta within 6 weeks at Visit 2.
Overall Number of Participants Analyzed 144 50
Measure Type: Number
Unit of Measure: Percentage of participants
19 12
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection [Relvar Ellipta+LAMA]+[Symb Turb+LAMA]+[Seretide Diskus+LAMA], Relvar Ellipta
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.404
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.502
Confidence Interval (2-Sided) 95%
0.578 to 3.905
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection [Relvar Ellipta+LAMA]+[Symb Turb+LAMA]+[Seretide Diskus+LAMA], Relvar Ellipta
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.330
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.591
Confidence Interval (2-Sided) 95%
0.625 to 4.050
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
21.Secondary Outcome
Title Percentage of Participants Making at Least One Overall Error at Visit 2 in Primary DPI (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI
Hide Description

Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. Any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps listed in PILs for the respective DPI. The errors were defined as “critical”, when the participant received a lesser/no dose and non-critical when the dose may not be affected, but the participant has demonstrated improper use of their DPI, as per PIL. Overall errors is the combination of critical and non-critical errors. The percentage of participants making at least one overall error in primary DPI is presented. The aim of the analysis was to compare percentage of participants making at least one overall error with Ellipta and Ellipta+LAMA versus Turbuhaler and Turbuhaler+LAMA and Diskus and Diskus+LAMA; hence, the arms were combined as pre-specified in the protocol and RAP.

.

Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants with data available at Visit 2 were analyzed.
Arm/Group Title Relvar Ellipta+[Relvar Ellipta+LAMA] Symbicort Turbuhaler+[Symbicort Turbuhaler+LAMA] Seretide Diskus+[Seretide Diskus+LAMA]
Hide Arm/Group Description:
All participants from Relvar Ellipta and Relvar Ellipta+LAMA arms were included.
All participants from Symbicort Turbuhaler and Symbicort Turbuhaler+LAMA arms were included.
All participants from Seretide Diskus and Seretide Diskus+LAMA arms were included.
Overall Number of Participants Analyzed 99 97 91
Measure Type: Number
Unit of Measure: Percentage of participants
13 25 27
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta+[Relvar Ellipta+LAMA], Symbicort Turbuhaler+[Symbicort Turbuhaler+LAMA]
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.189
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.738
Confidence Interval (2-Sided) 95%
0.761 to 3.968
Estimation Comments Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta+[Relvar Ellipta+LAMA], Seretide Diskus+[Seretide Diskus+LAMA]
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.086
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.079
Confidence Interval (2-Sided) 95%
0.901 to 4.799
Estimation Comments Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta+[Relvar Ellipta+LAMA], Symbicort Turbuhaler+[Symbicort Turbuhaler+LAMA]
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.082
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.950
Confidence Interval (2-Sided) 95%
0.918 to 4.142
Estimation Comments Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta+[Relvar Ellipta+LAMA], Seretide Diskus+[Seretide Diskus+LAMA]
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.415
Confidence Interval (2-Sided) 95%
1.161 to 5.024
Estimation Comments Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
22.Secondary Outcome
Title Percentage of Participants Making at Least One Overall Error at Visit 2-Dual Device Comparisons (Relvar Ellipta DPI Versus Relvar Ellipta With Any Other LAMA)
Hide Description Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. Any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as “critical”, when the participant received a lesser/no dose and non-critical when the dose may not be affected, but the participant has demonstrated improper use of their DPI, as per the PIL. Overall errors is the combination of critical and non-critical errors. The percentage of participants making at least one overall error in either one or both devices (where applicable) is presented.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants with data available at Visit 2 were analyzed.
Arm/Group Title Relvar Ellipta Relvar Ellipta+LAMA
Hide Arm/Group Description:
Participants prescribed a fixed dose combination of inhaled corticosteroid/long-acting beta agonist (ICS/LABA) via Relvar Ellipta for treatment of COPD were included. Participants were assessed for errors while using Relvar Ellipta prior to retraining on the correct use of Ellipta DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of Relvar Ellipta within 6 weeks at Visit 2.
Participants prescribed a fixed dose combination of ICS/LABA via Relvar Ellipta along with a fixed dose of LAMA via Spiriva Handihaler or Incruse Ellipta were included. Participants were assessed for errors while using combination DPI prior to retraining on the correct use of DPI at Visit 1 (Day 1). The participants were retrained on inhaler use following which they were reassessed for errors during use of combination DPI within 6 weeks at Visit 2.
Overall Number of Participants Analyzed 50 49
Measure Type: Number
Unit of Measure: Percentage of participants
12 16
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta, Relvar Ellipta+LAMA
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.472
Comments Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.510
Confidence Interval (2-Sided) 95%
0.492 to 4.633
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Relvar Ellipta, Relvar Ellipta+LAMA
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.553
Comments Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.402
Confidence Interval (2-Sided) 95%
0.459 to 4.283
Estimation Comments Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.
23.Secondary Outcome
Title Percentage of Participants Making at Least One Overall Error at Visit 2-Dual Device Comparisons (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI)
Hide Description