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A Study to Evaluate Annual Rate of Exacerbations and Safety of 3 Dosage Strengths of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

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ClinicalTrials.gov Identifier: NCT01017952
Recruitment Status : Completed
First Posted : November 23, 2009
Results First Posted : August 19, 2013
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Pulmonary Disease, Chronic Obstructive
Interventions Drug: FF/GW642444 Inhalation Powder
Drug: GW642444 Inhalation Powder
Enrollment 1635
Recruitment Details  
Pre-assignment Details At Visit (V) 1, eligible participants (par.) entered a 4-week, open-label Run-in Period (RIP) to establish a stable Baseline. At V 2, eligible par. were randomized to a 52-week, double-blind Treatment Period. 2635 par. were screened, 2092 par. entered the RIP, and 1635 par. were randomized, out of which 1633 par. received >=1 study treatment dose.
Arm/Group Title FP/SAL 250/50 µg BID VI 25 µg QD FF/VI 50/25 µg QD FF/VI 100/25 µg QD FF/VI 200/25 µg QD
Hide Arm/Group Description Participants (Par.) were instructed to take open label Fluticasone Propionate and Salmeterol (FP/SAL) 250/50 microgram (µg) twice daily (BID) from the ACCUHALER/DISKUS, one inhalation each morning and evening with approximately 12 hours between doses. In addition, all par. were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] and/or nebules) to be used as needed throughout the study. Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study. Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the NDPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study. Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the NDPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study. Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the NDPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
Period Title: 4-week, Open-label Run-In Period
Started 2092 0 0 0 0
Completed 1633 0 0 0 0
Not Completed 459 0 0 0 0
Reason Not Completed
Did Not Meet Continuation Criteria             356             0             0             0             0
Adverse Event             23             0             0             0             0
Study Closed/Tterminated             1             0             0             0             0
Lost to Follow-up             6             0             0             0             0
Physician Decision             10             0             0             0             0
Withdrawal by Subject             63             0             0             0             0
Period Title: 52-week, Double-blind Treatment Period
Started 0 409 412 403 409
Completed the Treatment Period 0 285 [1] 305 [1] 293 [1] 307 [1]
Completed 0 284 [2] 303 [2] 291 [2] 306 [2]
Not Completed 0 125 109 112 103
Reason Not Completed
Adverse Event             0             25             32             35             30
Withdrawal by Subject             0             30             22             25             25
Lack of Efficacy             0             35             14             16             14
Protocol Violation             0             7             11             9             8
Met Protocol-Defined Stopping Criteria             0             11             13             12             9
Study Closed/Terminated             0             1             1             0             0
Lost to Follow-up             0             6             8             6             10
Physician Decision             0             10             8             9             7
[1]
Par. completed the treatment period if they attended the last treatment visit (Visit 11).
[2]
Par. completed the study if they completed the treatment period and safety follow-up phone contact.
Arm/Group Title VI 25 µg QD FF/VI 50/25 µg QD FF/VI 100/25 µg QD FF/VI 200/25 µg QD Total
Hide Arm/Group Description Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study. Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the NDPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study. Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the NDPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study. Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the NDPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study. Total of all reporting groups
Overall Number of Baseline Participants 409 412 403 409 1633
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 409 participants 412 participants 403 participants 409 participants 1633 participants
63.6  (9.29) 63.7  (9.56) 64.0  (9.28) 63.5  (8.84) 63.7  (9.24)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 409 participants 412 participants 403 participants 409 participants 1633 participants
Female
174
  42.5%
181
  43.9%
181
  44.9%
191
  46.7%
727
  44.5%
Male
235
  57.5%
231
  56.1%
222
  55.1%
218
  53.3%
906
  55.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 409 participants 412 participants 403 participants 409 participants 1633 participants
White 360 359 353 359 1431
African American/ African Heritage 9 14 7 9 39
Asian 4 3 5 3 15
African American/African Heritage & White 0 1 1 0 2
American Indian or Alaska Native & White 20 19 21 20 80
Asian & White 0 0 0 1 1
Native Hawaiian or other Pacific Islander 0 0 0 1 1
American Indian or Alaska Native 16 16 16 16 64
1.Primary Outcome
Title Annual Rate of Moderate and Severe COPD Exacerbations Expressed as Least Square Mean
Hide Description The annual rate of moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations during the treatment (trt) period (per participant [par.] per year) was assessed. An exacerbation of COPD, is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptoms (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. The COPD exacerbation was categorized as mild, moderate and severe by the investigator. Mild: worsening symptoms of COPD that were self-managed by the par. without the use of oral corticosteroids or antibiotics; Moderate: worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics; Severe: worsening symptoms of COPD that required treatment with in-patient hospitalization.
Time Frame From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all par. randomized who received at least 1 dose of study drug and with available data for analysis. Analysis used a negative binomial regression model with covariates of trt, smoking status at Screening, Baseline pre-dose Day 1 % predicted FEV1 and region and with logarithm of time on trt as an offset variable.
Arm/Group Title VI 25 µg QD FF/VI 50/25 µg QD FF/VI 100/25 µg QD FF/VI 200/25 µg QD
Hide Arm/Group Description:
Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
Overall Number of Participants Analyzed 409 412 403 409
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Exacerbations per participant per year
1.14
(0.99 to 1.32)
0.92
(0.79 to 1.07)
0.90
(0.77 to 1.05)
0.79
(0.67 to 0.92)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VI 25 µg QD, FF/VI 50/25 µg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.040
Comments [Not Specified]
Method Generalized Linear Model
Comments Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.81
Confidence Interval (2-Sided) 95%
0.66 to 0.99
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VI 25 µg QD, FF/VI 100/25 µg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.024
Comments [Not Specified]
Method Generalized Linear Model
Comments Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
0.64 to 0.97
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection VI 25 µg QD, FF/VI 200/25 µg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Generalized Linear Model
Comments Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.69
Confidence Interval (2-Sided) 95%
0.56 to 0.85
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Time to First Occurrence of Moderate or Severe COPD Exacerbation
Hide Description Time to first occurrence analyzed by using a Cox proportional hazards model with covariates of treatment, smoking status at screening (stratum), baseline disease severity (pre-dose Day 1 % predicted FEV1) and centre grouping. An exacerbation of COPD is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptoms (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. A moderate exacerbation is defined as worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics. A severe exacerbation is defined as worsening symptoms of COPD that required treatment with in-patient hospitalization. The number of participants with a moderate or severe COPD exacerbation while on treatment are presented.
Time Frame From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title VI 25 µg QD FF/VI 50/25 µg QD FF/VI 100/25 µg QD FF/VI 200/25 µg QD
Hide Arm/Group Description:
Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
Overall Number of Participants Analyzed 409 412 403 409
Measure Type: Number
Unit of Measure: Participants
197 198 177 160
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VI 25 µg QD, FF/VI 50/25 µg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.177
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.71 to 1.06
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VI 25 µg QD, FF/VI 100/25 µg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.036
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.66 to 0.99
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection VI 25 µg QD, FF/VI 200/25 µg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.66
Confidence Interval (2-Sided) 95%
0.54 to 0.82
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Annual Rate of Exacerbations Requiring Systemic/Oral Corticosteroids Expressed as Least Square Mean
Hide Description The annual rate of COPD exacerbations during the treatment period (per participant per year) that required systemic/oral corticosteroids was assessed. An exacerbation of COPD is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptom (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. The COPD exacerbation was categorized as mild, moderate, and severe by the investigator. Mild: worsening symptoms of COPD that were self-managed by the participant. Mild exacerbations were not associated with the use of oral corticosteroids or antibiotics. Moderate: worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics. Severe: worsening symptoms of COPD that required treatment with in-patient hospitalization.
Time Frame From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all par. randomized who received at least 1 dose of study drug and with available data for analysis. Analysis used a negative binomial regression model with covariates of trt, smoking status at Screening, Baseline pre-dose Day 1 % predicted FEV1 and region and with logarithm of time on trt as an offset variable.
Arm/Group Title VI 25 µg QD FF/VI 50/25 µg QD FF/VI 100/25 µg QD FF/VI 200/25 µg QD
Hide Arm/Group Description:
Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
Overall Number of Participants Analyzed 409 412 403 409
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Exacerbations per participant per year
0.86
(0.72 to 1.03)
0.72
(0.60 to 0.86)
0.66
(0.55 to 0.80)
0.56
(0.46 to 0.68)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VI 25 µg QD, FF/VI 50/25 µg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.154
Comments [Not Specified]
Method Generalized Linear Model
Comments Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.65 to 1.07
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VI 25 µg QD, FF/VI 100/25 µg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.041
Comments [Not Specified]
Method Generalized Linear Model
Comments Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.60 to 0.99
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection VI 25 µg QD, FF/VI 200/25 µg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Generalized Linear Model
Comments Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.65
Confidence Interval (2-Sided) 95%
0.51 to 0.84
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Trough FEV1 at Week 52 (Visit 11)
Hide Description Pulmonary function was measured by forced expiratory volume in one second (FEV1). Trough FEV1 was defined as the 24-hour post-dose FEV1 assessment, which was obtained at each visit. Analysis performed using a repeated measures model with covariates of treatment, smoking status at Screening (stratum), baseline (pre-dose Day 1), centre grouping, Week, Week by Baseline, and Week by treatment interactions.
Time Frame Baseline to Visit 11 (Week 52)/Early Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Number of participants presented represent those with data available at the time point being presented, however all participants in the ITT population without missing covariate information and with at least one post Baseline measurement are included in the analysis.
Arm/Group Title VI 25 µg QD FF/VI 50/25 µg QD FF/VI 100/25 µg QD FF/VI 200/25 µg QD
Hide Arm/Group Description:
Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
Overall Number of Participants Analyzed 276 304 287 300
Least Squares Mean (Standard Error)
Unit of Measure: Liters
-0.019  (0.0116) 0.015  (0.0113) 0.005  (0.0115) 0.006  (0.0113)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VI 25 µg QD, FF/VI 50/25 µg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.034
Comments Nominal p-value
Method Mixed Models Analysis
Comments Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 0.034
Confidence Interval (2-Sided) 95%
0.003 to 0.066
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VI 25 µg QD, FF/VI 100/25 µg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.143
Comments [Not Specified]
Method Mixed Models Analysis
Comments Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 0.024
Confidence Interval (2-Sided) 95%
-0.008 to 0.056
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection VI 25 µg QD, FF/VI 200/25 µg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.115
Comments [Not Specified]
Method Mixed Models Analysis
Comments Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 0.026
Confidence Interval (2-Sided) 95%
-0.006 to 0.057
Estimation Comments [Not Specified]
Time Frame Serious adverse events (SAEs) and non-serious AEs will be collected from Baseline to the end of the treatment period (up to 52 weeks).
Adverse Event Reporting Description SAEs and non-serious adverse events are reported for members of the Intent-to-Treat Population, comprised of all randomized participants who received at least one dose of study medication during the treatment period.
 
Arm/Group Title VI 25 µg QD FF/VI 50/25 µg QD FF/VI 100/25 µg QD FF/VI 200/25 µg QD
Hide Arm/Group Description Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study. Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study. Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study. Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
All-Cause Mortality
VI 25 µg QD FF/VI 50/25 µg QD FF/VI 100/25 µg QD FF/VI 200/25 µg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
VI 25 µg QD FF/VI 50/25 µg QD FF/VI 100/25 µg QD FF/VI 200/25 µg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   66/409 (16.14%)   71/412 (17.23%)   67/403 (16.63%)   61/409 (14.91%) 
Blood and lymphatic system disorders         
Anaemia  1  1/409 (0.24%)  0/412 (0.00%)  2/403 (0.50%)  0/409 (0.00%) 
Cardiac disorders         
Atrial fibrillation  1  1/409 (0.24%)  1/412 (0.24%)  2/403 (0.50%)  0/409 (0.00%) 
Acute myocardial infarction  1  0/409 (0.00%)  1/412 (0.24%)  2/403 (0.50%)  0/409 (0.00%) 
Angina pectoris  1  1/409 (0.24%)  1/412 (0.24%)  0/403 (0.00%)  0/409 (0.00%) 
Bradycardia  1  0/409 (0.00%)  0/412 (0.00%)  0/403 (0.00%)  2/409 (0.49%) 
Cardiac arrest  1  0/409 (0.00%)  1/412 (0.24%)  1/403 (0.25%)  0/409 (0.00%) 
Cardiac failure  1  1/409 (0.24%)  0/412 (0.00%)  1/403 (0.25%)  0/409 (0.00%) 
Myocardial infarction  1  0/409 (0.00%)  1/412 (0.24%)  0/403 (0.00%)  1/409 (0.24%) 
Supraventricular tachycardia  1  2/409 (0.49%)  0/412 (0.00%)  0/403 (0.00%)  0/409 (0.00%) 
Tachycardia  1  0/409 (0.00%)  0/412 (0.00%)  2/403 (0.50%)  0/409 (0.00%) 
Angina unstable  1  0/409 (0.00%)  1/412 (0.24%)  0/403 (0.00%)  0/409 (0.00%) 
Atrial flutter  1  0/409 (0.00%)  0/412 (0.00%)  0/403 (0.00%)  1/409 (0.24%) 
Cardiac failure congestive  1  0/409 (0.00%)  0/412 (0.00%)  1/403 (0.25%)  0/409 (0.00%) 
Cardiomyopathy  1  0/409 (0.00%)  1/412 (0.24%)  0/403 (0.00%)  0/409 (0.00%) 
Coronary artery disease  1  0/409 (0.00%)  1/412 (0.24%)  0/403 (0.00%)  0/409 (0.00%) 
Coronary artery stenosis  1  1/409 (0.24%)  0/412 (0.00%)  0/403 (0.00%)  0/409 (0.00%) 
Myocardial ischaemia  1  0/409 (0.00%)  0/412 (0.00%)  1/403 (0.25%)  0/409 (0.00%) 
Tachyarrhythmia  1  0/409 (0.00%)  0/412 (0.00%)  0/403 (0.00%)  1/409 (0.24%) 
Ventricular tachycardia  1  0/409 (0.00%)  0/412 (0.00%)  1/403 (0.25%)  0/409 (0.00%) 
Ear and labyrinth disorders         
Vertigo  1  0/409 (0.00%)  1/412 (0.24%)  0/403 (0.00%)  0/409 (0.00%) 
Endocrine disorders         
Hyperthyroidism  1  0/409 (0.00%)  0/412 (0.00%)  1/403 (0.25%)  1/409 (0.24%) 
Eye disorders         
Eye haemorrhage  1  0/409 (0.00%)  0/412 (0.00%)  0/403 (0.00%)  1/409 (0.24%) 
Gastrointestinal disorders         
Abdominal hernia  1  0/409 (0.00%)  1/412 (0.24%)  0/403 (0.00%)  1/409 (0.24%) 
Abdominal pain  1  0/409 (0.00%)  2/412 (0.49%)  0/403 (0.00%)  0/409 (0.00%) 
Constipation  1  0/409 (0.00%)  2/412 (0.49%)  0/403 (0.00%)  0/409 (0.00%) 
Small intestinal obstruction  1  1/409 (0.24%)  1/412 (0.24%)  0/403 (0.00%)  0/409 (0.00%) 
Abdominal adhesions  1  0/409 (0.00%)  1/412 (0.24%)  0/403 (0.00%)  0/409 (0.00%) 
Diverticulum intestinal  1  0/409 (0.00%)  1/412 (0.24%)  0/403 (0.00%)  0/409 (0.00%) 
Duodenal ulcer  1  0/409 (0.00%)  0/412 (0.00%)  0/403 (0.00%)  1/409 (0.24%) 
Gastric ulcer  1  0/409 (0.00%)  0/412 (0.00%)  0/403 (0.00%)  1/409 (0.24%) 
Gastrooesophageal reflux disease  1  0/409 (0.00%)  0/412 (0.00%)  1/403 (0.25%)  0/409 (0.00%) 
Ileus  1  0/409 (0.00%)  0/412 (0.00%)  0/403 (0.00%)  1/409 (0.24%) 
Inguinal hernia  1  0/409 (0.00%)  0/412 (0.00%)  0/403 (0.00%)  1/409 (0.24%) 
Intestinal obstruction  1  0/409 (0.00%)  1/412 (0.24%)  0/403 (0.00%)  0/409 (0.00%) 
Intestinal perforation  1  0/409 (0.00%)  1/412 (0.24%)  0/403 (0.00%)  0/409 (0.00%) 
Megacolon  1  1/409 (0.24%)  0/412 (0.00%)  0/403 (0.00%)  0/409 (0.00%) 
Oesophageal achalasia  1  0/409 (0.00%)  1/412 (0.24%)  0/403 (0.00%)  0/409 (0.00%) 
Oesophageal stenosis  1  1/409 (0.24%)  0/412 (0.00%)  0/403 (0.00%)  0/409 (0.00%) 
Pancreatitis acute  1  1/409 (0.24%)  0/412 (0.00%)  0/403 (0.00%)  0/409 (0.00%) 
General disorders         
Non-cardiac chest pain  1  2/409 (0.49%)  1/412 (0.24%)  0/403 (0.00%)  0/409 (0.00%) 
Chest pain  1  0/409 (0.00%)  0/412 (0.00%)  1/403 (0.25%)  1/409 (0.24%) 
Fatigue  1  0/409 (0.00%)  0/412 (0.00%)  1/403 (0.25%)  0/409 (0.00%) 
Hepatobiliary disorders         
Cholelithiasis  1  1/409 (0.24%)  1/412 (0.24%)  2/403 (0.50%)  0/409 (0.00%) 
Cholecystitis  1  1/409 (0.24%)  0/412 (0.00%)  1/403 (0.25%)  0/409 (0.00%) 
Cholecystitis acute  1  0/409 (0.00%)  0/412 (0.00%)  1/403 (0.25%)  0/409 (0.00%) 
Immune system disorders         
Anaphylactic shock  1  0/409 (0.00%)  1/412 (0.24%)  0/403 (0.00%)  0/409 (0.00%) 
Infections and infestations         
Pneumonia  1  6/409 (1.47%)  10/412 (2.43%)  12/403 (2.98%)  9/409 (2.20%) 
Infective exacerbation of chronic obstructive airways diseas  1  0/409 (0.00%)  2/412 (0.49%)  2/403 (0.50%)  3/409 (0.73%) 
Bronchitis  1  2/409 (0.49%)  2/412 (0.49%)  1/403 (0.25%)  0/409 (0.00%) 
Cellulitis  1  0/409 (0.00%)  0/412 (0.00%)  2/403 (0.50%)  1/409 (0.24%) 
Lower respiratory tract infection  1  1/409 (0.24%)  0/412 (0.00%)  0/403 (0.00%)  2/409 (0.49%) 
Diverticulitis  1  1/409 (0.24%)  1/412 (0.24%)  0/403 (0.00%)  0/409 (0.00%) 
Lobar pneumonia  1  0/409 (0.00%)  0/412 (0.00%)  2/403 (0.50%)  0/409 (0.00%) 
Urinary tract infection  1  0/409 (0.00%)  0/412 (0.00%)  1/403 (0.25%)  1/409 (0.24%) 
Abscess limb  1  0/409 (0.00%)  1/412 (0.24%)  0/403 (0.00%)  0/409 (0.00%) 
Bacteraemia  1  0/409 (0.00%)  1/412 (0.24%)  0/403 (0.00%)  0/409 (0.00%) 
Gastroenteritis  1  0/409 (0.00%)  1/412 (0.24%)  0/403 (0.00%)  0/409 (0.00%) 
Lung abscess  1  0/409 (0.00%)  0/412 (0.00%)  1/403 (0.25%)  0/409 (0.00%) 
Pelvic inflammatory disease  1  0/409 (0.00%)  0/412 (0.00%)  0/403 (0.00%)  1/409 (0.24%) 
Pneumonia primary atypical  1  0/409 (0.00%)  0/412 (0.00%)  1/403 (0.25%)  0/409 (0.00%) 
Postoperative wound infection  1  0/409 (0.00%)  0/412 (0.00%)  1/403 (0.25%)  0/409 (0.00%) 
Pyelonephritis  1  0/409 (0.00%)  0/412 (0.00%)  1/403 (0.25%)  0/409 (0.00%) 
Tracheobronchitis  1  0/409 (0.00%)  0/412 (0.00%)  1/403 (0.25%)  0/409 (0.00%) 
Injury, poisoning and procedural complications         
Hip fracture  1  1/409 (0.24%)  2/412 (0.49%)  0/403 (0.00%)  0/409 (0.00%) 
Acetabulum fracture  1  1/409 (0.24%)  0/412 (0.00%)  0/403 (0.00%)  0/409 (0.00%) 
Concussion  1  0/409 (0.00%)  0/412 (0.00%)  0/403 (0.00%)  1/409 (0.24%) 
Contusion  1  0/409 (0.00%)  0/412 (0.00%)  0/403 (0.00%)  1/409 (0.24%) 
Fall  1  0/409 (0.00%)  0/412 (0.00%)  1/403 (0.25%)  0/409 (0.00%) 
Femur fracture  1  0/409 (0.00%)  0/412 (0.00%)  0/403 (0.00%)  1/409 (0.24%) 
Humerus fracture  1  0/409 (0.00%)  0/412 (0.00%)  1/403 (0.25%)  0/409 (0.00%) 
Muscle strain  1  1/409 (0.24%)  0/412 (0.00%)  0/403 (0.00%)  0/409 (0.00%) 
Pelvic fracture  1  0/409 (0.00%)  0/412 (0.00%)  1/403 (0.25%)  0/409 (0.00%) 
Rib fracture  1  0/409 (0.00%)  1/412 (0.24%)  0/403 (0.00%)  0/409 (0.00%) 
Road traffic accident  1  0/409 (0.00%)  1/412 (0.24%)  0/403 (0.00%)  0/409 (0.00%) 
Spinal compression fracture  1  0/409 (0.00%)  0/412 (0.00%)  1/403 (0.25%)  0/409 (0.00%) 
Traumatic haematoma  1  1/409 (0.24%)  0/412 (0.00%)  0/403 (0.00%)  0/409 (0.00%) 
Investigations         
Blood pressure increased  1  0/409 (0.00%)  0/412 (0.00%)  1/403 (0.25%)  0/409 (0.00%) 
Electrocardiogram abnormal  1  0/409 (0.00%)  0/412 (0.00%)  1/403 (0.25%)  0/409 (0.00%) 
Metabolism and nutrition disorders         
Hyponatraemia  1  1/409 (0.24%)  0/412 (0.00%)  1/403 (0.25%)  0/409 (0.00%) 
Gout  1  0/409 (0.00%)  0/412 (0.00%)  0/403 (0.00%)  1/409 (0.24%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  1/409 (0.24%)  0/412 (0.00%)  1/403 (0.25%)  0/409 (0.00%) 
Musculoskeletal chest pain  1  2/409 (0.49%)  0/412 (0.00%)  0/403 (0.00%)  0/409 (0.00%) 
Arthropathy  1  0/409 (0.00%)  0/412 (0.00%)  0/403 (0.00%)  1/409 (0.24%) 
Osteoarthritis  1  0/409 (0.00%)  1/412 (0.24%)  0/403 (0.00%)  0/409 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Lung squamous cell carcinoma stage unspecified  1  0/409 (0.00%)  1/412 (0.24%)  1/403 (0.25%)  1/409 (0.24%) 
Prostate cancer  1  0/409 (0.00%)  1/412 (0.24%)  0/403 (0.00%)  1/409 (0.24%) 
Small cell lung cancer stage unspecified  1  0/409 (0.00%)  1/412 (0.24%)  0/403 (0.00%)  1/409 (0.24%) 
Thyroid cancer  1  0/409 (0.00%)  0/412 (0.00%)  0/403 (0.00%)  2/409 (0.49%) 
B-cell lymphoma  1  1/409 (0.24%)  0/412 (0.00%)  0/403 (0.00%)  0/409 (0.00%) 
Basal cell carcinoma  1  0/409 (0.00%)  0/412 (0.00%)  1/403 (0.25%)  0/409 (0.00%) 
Bladder cancer  1  1/409 (0.24%)  0/412 (0.00%)  0/403 (0.00%)  0/409 (0.00%) 
Bladder neoplasm  1  0/409 (0.00%)  0/412 (0.00%)  1/403 (0.25%)  0/409 (0.00%) 
Bone neoplasm  1  1/409 (0.24%)  0/412 (0.00%)  0/403 (0.00%)  0/409 (0.00%) 
Breast cancer  1  0/409 (0.00%)  0/412 (0.00%)  0/403 (0.00%)  1/409 (0.24%) 
Bronchial neoplasm  1  0/409 (0.00%)  0/412 (0.00%)  0/403 (0.00%)  1/409 (0.24%) 
Laryngeal cancer  1  1/409 (0.24%)  0/412 (0.00%)  0/403 (0.00%)  0/409 (0.00%) 
Leukaemia  1  0/409 (0.00%)  0/412 (0.00%)  0/403 (0.00%)  1/409 (0.24%) 
Lung neoplasm  1  0/409 (0.00%)  0/412 (0.00%)  0/403 (0.00%)  1/409 (0.24%) 
Lung neoplasm malignant  1  1/409 (0.24%)  0/412 (0.00%)  0/403 (0.00%)  0/409 (0.00%) 
Malignant melanoma  1  0/409 (0.00%)  0/412 (0.00%)  0/403 (0.00%)  1/409 (0.24%) 
Metastases to bone  1  0/409 (0.00%)  0/412 (0.00%)  1/403 (0.25%)  0/409 (0.00%) 
Metastases to gastrointestinal tract  1  0/409 (0.00%)  1/412 (0.24%)  0/403 (0.00%)  0/409 (0.00%) 
Metastatic squamous cell carcinoma  1  1/409 (0.24%)  0/412 (0.00%)  0/403 (0.00%)  0/409 (0.00%) 
Neoplasm malignant  1  1/409 (0.24%)  0/412 (0.00%)  0/403 (0.00%)  0/409 (0.00%) 
Neoplasm recurrence  1  0/409 (0.00%)  1/412 (0.24%)  0/403 (0.00%)  0/409 (0.00%) 
Neuroendocrine tumour  1  0/409 (0.00%)  1/412 (0.24%)  0/403 (0.00%)  0/409 (0.00%) 
Pelvic neoplasm  1  1/409 (0.24%)  0/412 (0.00%)  0/403 (0.00%)  0/409 (0.00%) 
Pituitary tumour benign  1  0/409 (0.00%)  1/412 (0.24%)  0/403 (0.00%)  0/409 (0.00%) 
Renal cancer  1  1/409 (0.24%)  0/412 (0.00%)  0/403 (0.00%)  0/409 (0.00%) 
Renal cell carcinoma  1  0/409 (0.00%)  0/412 (0.00%)  0/403 (0.00%)  1/409 (0.24%) 
Skin cancer  1  0/409 (0.00%)  1/412 (0.24%)  0/403 (0.00%)  0/409 (0.00%) 
Squamous cell carcinoma  1  0/409 (0.00%)  1/412 (0.24%)  0/403 (0.00%)  0/409 (0.00%) 
Uterine leiomyoma  1  0/409 (0.00%)  0/412 (0.00%)  1/403 (0.25%)  0/409 (0.00%) 
Nervous system disorders         
Cerebrovascular accident  1  2/409 (0.49%)  1/412 (0.24%)  0/403 (0.00%)  1/409 (0.24%) 
Syncope  1  0/409 (0.00%)  1/412 (0.24%)  2/403 (0.50%)  0/409 (0.00%) 
Cerebral ischaemia  1  0/409 (0.00%)  1/412 (0.24%)  0/403 (0.00%)  0/409 (0.00%) 
Convulsion  1  1/409 (0.24%)  0/412 (0.00%)  0/403 (0.00%)  0/409 (0.00%) 
Ischaemic stroke  1  0/409 (0.00%)  1/412 (0.24%)  0/403 (0.00%)  0/409 (0.00%) 
Presyncope  1  1/409 (0.24%)  0/412 (0.00%)  0/403 (0.00%)  0/409 (0.00%) 
Subarachnoid haemorrhage  1  0/409 (0.00%)  0/412 (0.00%)  1/403 (0.25%)  0/409 (0.00%) 
Transient ischaemic attack  1  0/409 (0.00%)  0/412 (0.00%)  0/403 (0.00%)  1/409 (0.24%) 
Psychiatric disorders         
Major depression  1  0/409 (0.00%)  0/412 (0.00%)  1/403 (0.25%)  1/409 (0.24%) 
Suicidal ideation  1  0/409 (0.00%)  0/412 (0.00%)  1/403 (0.25%)  0/409 (0.00%) 
Renal and urinary disorders         
Renal failure acute  1  1/409 (0.24%)  0/412 (0.00%)  1/403 (0.25%)  0/409 (0.00%) 
Calculus ureteric  1  0/409 (0.00%)  0/412 (0.00%)  0/403 (0.00%)  1/409 (0.24%) 
Haematuria  1  0/409 (0.00%)  0/412 (0.00%)  0/403 (0.00%)  1/409 (0.24%) 
Urinary bladder polyp  1  0/409 (0.00%)  1/412 (0.24%)  0/403 (0.00%)  0/409 (0.00%) 
Reproductive system and breast disorders         
Benign prostatic hyperplasia  1  1/409 (0.24%)  0/412 (0.00%)  0/403 (0.00%)  0/409 (0.00%) 
Cervical dysplasia  1  1/409 (0.24%)  0/412 (0.00%)  0/403 (0.00%)  0/409 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Chronic obstructive pulmonary disease  1  25/409 (6.11%)  26/412 (6.31%)  29/403 (7.20%)  23/409 (5.62%) 
Pneumothorax  1  0/409 (0.00%)  2/412 (0.49%)  1/403 (0.25%)  1/409 (0.24%) 
Respiratory failure  1  0/409 (0.00%)  2/412 (0.49%)  0/403 (0.00%)  2/409 (0.49%) 
Dyspnoea  1  1/409 (0.24%)  0/412 (0.00%)  1/403 (0.25%)  1/409 (0.24%) 
Pleural effusion  1  1/409 (0.24%)  1/412 (0.24%)  0/403 (0.00%)  0/409 (0.00%) 
Acute respiratory failure  1  1/409 (0.24%)  0/412 (0.00%)  0/403 (0.00%)  0/409 (0.00%) 
Chronic respiratory failure  1  1/409 (0.24%)  0/412 (0.00%)  0/403 (0.00%)  0/409 (0.00%) 
Haemoptysis  1  1/409 (0.24%)  0/412 (0.00%)  0/403 (0.00%)  0/409 (0.00%) 
Hypoxia  1  0/409 (0.00%)  0/412 (0.00%)  1/403 (0.25%)  0/409 (0.00%) 
Pulmonary bulla  1  0/409 (0.00%)  1/412 (0.24%)  0/403 (0.00%)  0/409 (0.00%) 
Pulmonary hypertension  1  0/409 (0.00%)  0/412 (0.00%)  1/403 (0.25%)  0/409 (0.00%) 
Pulmonary oedema  1  0/409 (0.00%)  0/412 (0.00%)  0/403 (0.00%)  1/409 (0.24%) 
Respiratory distress  1  0/409 (0.00%)  0/412 (0.00%)  1/403 (0.25%)  0/409 (0.00%) 
Skin and subcutaneous tissue disorders         
Angioedema  1  0/409 (0.00%)  0/412 (0.00%)  1/403 (0.25%)  0/409 (0.00%) 
Urticaria  1  0/409 (0.00%)  0/412 (0.00%)  1/403 (0.25%)  0/409 (0.00%) 
Vascular disorders         
Aortic aneurysm  1  0/409 (0.00%)  0/412 (0.00%)  0/403 (0.00%)  1/409 (0.24%) 
Arteriosclerosis  1  1/409 (0.24%)  0/412 (0.00%)  0/403 (0.00%)  0/409 (0.00%) 
Circulatory collapse  1  0/409 (0.00%)  0/412 (0.00%)  0/403 (0.00%)  1/409 (0.24%) 
Deep vein thrombosis  1  0/409 (0.00%)  0/412 (0.00%)  0/403 (0.00%)  1/409 (0.24%) 
Haemorrhage  1  0/409 (0.00%)  0/412 (0.00%)  1/403 (0.25%)  0/409 (0.00%) 
Labile blood pressure  1  1/409 (0.24%)  0/412 (0.00%)  0/403 (0.00%)  0/409 (0.00%) 
Peripheral arterial occlusive disease  1  1/409 (0.24%)  0/412 (0.00%)  0/403 (0.00%)  0/409 (0.00%) 
Thrombophlebitis  1  1/409 (0.24%)  0/412 (0.00%)  0/403 (0.00%)  0/409 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
VI 25 µg QD FF/VI 50/25 µg QD FF/VI 100/25 µg QD FF/VI 200/25 µg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   211/409 (51.59%)   229/412 (55.58%)   239/403 (59.31%)   249/409 (60.88%) 
Gastrointestinal disorders         
Diarrhoea  1  4/409 (0.98%)  10/412 (2.43%)  14/403 (3.47%)  15/409 (3.67%) 
General disorders         
Oedema peripheral  1  16/409 (3.91%)  12/412 (2.91%)  12/403 (2.98%)  8/409 (1.96%) 
Infections and infestations         
Nasopharyngitis  1  58/409 (14.18%)  54/412 (13.11%)  68/403 (16.87%)  82/409 (20.05%) 
Oral candidiasis  1  29/409 (7.09%)  39/412 (9.47%)  39/403 (9.68%)  40/409 (9.78%) 
Upper respiratory tract infection  1  31/409 (7.58%)  37/412 (8.98%)  39/403 (9.68%)  36/409 (8.80%) 
Sinusitis  1  19/409 (4.65%)  26/412 (6.31%)  20/403 (4.96%)  27/409 (6.60%) 
Bronchitis  1  20/409 (4.89%)  25/412 (6.07%)  16/403 (3.97%)  23/409 (5.62%) 
Influenza  1  6/409 (1.47%)  18/412 (4.37%)  14/403 (3.47%)  18/409 (4.40%) 
Pharyngitis  1  12/409 (2.93%)  10/412 (2.43%)  10/403 (2.48%)  13/409 (3.18%) 
Rhinitis  1  12/409 (2.93%)  14/412 (3.40%)  5/403 (1.24%)  10/409 (2.44%) 
Pneumonia  1  6/409 (1.47%)  8/412 (1.94%)  14/403 (3.47%)  11/409 (2.69%) 
Lower respiratory tract infection  1  13/409 (3.18%)  7/412 (1.70%)  12/403 (2.98%)  5/409 (1.22%) 
Oropharyngeal candidiasis  1  3/409 (0.73%)  15/412 (3.64%)  11/403 (2.73%)  5/409 (1.22%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  23/409 (5.62%)  19/412 (4.61%)  30/403 (7.44%)  17/409 (4.16%) 
Arthralgia  1  17/409 (4.16%)  6/412 (1.46%)  20/403 (4.96%)  13/409 (3.18%) 
Nervous system disorders         
Headache  1  30/409 (7.33%)  34/412 (8.25%)  32/403 (7.94%)  33/409 (8.07%) 
Respiratory, thoracic and mediastinal disorders         
Oropharyngeal pain  1  18/409 (4.40%)  23/412 (5.58%)  17/403 (4.22%)  26/409 (6.36%) 
Cough  1  20/409 (4.89%)  14/412 (3.40%)  15/403 (3.72%)  22/409 (5.38%) 
Dyspnoea  1  16/409 (3.91%)  12/412 (2.91%)  13/403 (3.23%)  10/409 (2.44%) 
Vascular disorders         
Hypertension  1  16/409 (3.91%)  12/412 (2.91%)  10/403 (2.48%)  15/409 (3.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01017952     History of Changes
Other Study ID Numbers: 102970
First Submitted: November 19, 2009
First Posted: November 23, 2009
Results First Submitted: May 30, 2013
Results First Posted: August 19, 2013
Last Update Posted: August 31, 2018