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Trial record 22 of 318 for:    FLUTICASONE AND SALMETEROL

Assessment of Switching From Salmeterol/Fluticasone to Indacaterol/Glycopyrronium in a symtomaticCOPD Patient Cohort (FLASH)

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ClinicalTrials.gov Identifier: NCT02516592
Recruitment Status : Completed
First Posted : August 6, 2015
Results First Posted : March 21, 2019
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition COPD
Interventions Drug: QVA149 110/50 micrograms
Drug: Salmeterol/fluticasone 50/500 microgrammes
Enrollment 500
Recruitment Details A total of 502 patients were randomized, of which 498 patients were included in the Full Analysis Set (FAS)
Pre-assignment Details  
Arm/Group Title QVA149 110/50 Micrograms Salmeterol/Fluticasone 50/500 Micrograms
Hide Arm/Group Description QVA149 110/50 micrograms o.d. Capsules for inhalation salmeterol/fluticasone 50/500 micrograms b.i.d. Dry inhalation powder
Period Title: Overall Study
Started 251 251
Full Analysis Set 248 250
Completed 235 238
Not Completed 16 13
Reason Not Completed
Patient withdrew consent             5             2
Protocol deviation             4             4
Lost to Follow-up             2             3
Patient/guardian decision             2             1
Adverse Event             1             2
Abnormal test procedure result             1             0
Death             1             1
Arm/Group Title QVA149 110/50 Micrograms Salmeterol/Fluticasone 50/500 Micrograms Total
Hide Arm/Group Description QVA149 110/50 micrograms o.d. Capsules for inhalation salmeterol/fluticasone 50/500 micrograms b.i.d. Dry inhalation powder Total of all reporting groups
Overall Number of Baseline Participants 251 251 502
Hide Baseline Analysis Population Description
The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to. A total of 502 patients were randomized, of which 498 patients were included in the Full Analysis Set (FAS)
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 248 participants 250 participants 498 participants
65  (9.14) 65.1  (8.44) 65  (8.79)
[1]
Measure Analysis Population Description: The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 248 participants 250 participants 498 participants
Female
28
  11.3%
26
  10.4%
54
  10.8%
Male
220
  88.7%
224
  89.6%
444
  89.2%
[1]
Measure Analysis Population Description: The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to.
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 248 participants 250 participants 498 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
115
  46.4%
118
  47.2%
233
  46.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   0.8%
0
   0.0%
2
   0.4%
White
123
  49.6%
126
  50.4%
249
  50.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
8
   3.2%
6
   2.4%
14
   2.8%
[1]
Measure Analysis Population Description: The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to
1.Primary Outcome
Title Change From Baseline in Trough Pre-dose FEV1 in Both Arms
Hide Description Pulmonary function assessments were performed using centralized spirometry according to international standards. Mean trough pre-dose FEV1 at Week 12 is defined as the average of the measurements taken -45min and -15min pre study medication dose in the clinic after 12 weeks of treatment (Day 84). The baseline measurement is defined as the average of the scheduled FEV1 values prior to first intake of randomized study drug at Day 1 (Visit 2).
Time Frame Baseline, week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to
Arm/Group Title QVA149 110/50 Micrograms Salmeterol/Fluticasone 50/500 Micrograms
Hide Arm/Group Description:
QVA149 110/50 micrograms o.d. Capsules for inhalation
salmeterol/fluticasone 50/500 micrograms b.i.d. Dry inhalation powder
Overall Number of Participants Analyzed 248 250
Least Squares Mean (Standard Error)
Unit of Measure: Liters
0.036  (0.0151) -0.009  (0.0152)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QVA149 110/50 Micrograms, Salmeterol/Fluticasone 50/500 Micrograms
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.028
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.045
Confidence Interval (2-Sided) 95%
0.005 to 0.084
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Transitional Dyspnea Index (TDI) Focal Score
Hide Description Transition Dyspnea Index (TDI) is an instrument used to assess a participant's level of dyspnea. The TDI focal score have three domains: functional impairment, magnitude of task and magnitude of effort. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of ≥1 was defined as a clinically important improvement from baseline.
Time Frame Baseline, week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to.
Arm/Group Title QVA149 110/50 Micrograms Salmeterol/Fluticasone 50/500 Micrograms
Hide Arm/Group Description:
QVA149 110/50 micrograms o.d. Capsules for inhalation
salmeterol/fluticasone 50/500 micrograms b.i.d. Dry inhalation powder
Overall Number of Participants Analyzed 248 250
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
3.24  (0.405) 2.79  (0.399)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QVA149 110/50 Micrograms, Salmeterol/Fluticasone 50/500 Micrograms
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.063
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.46
Confidence Interval (2-Sided) 95%
-0.03 to 0.94
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in FVC (Forced Vital Capacity)
Hide Description Pulmonary function assessments were performed using centralized spirometry according to international standards. FVC wil follow the same analysis as for FEV1
Time Frame week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to
Arm/Group Title QVA149 110/50 Micrograms Salmeterol/Fluticasone 50/500 Micrograms
Hide Arm/Group Description:
QVA149 110/50 micrograms o.d. Capsules for inhalation
salmeterol/fluticasone 50/500 micrograms b.i.d. Dry inhalation powder
Overall Number of Participants Analyzed 248 250
Least Squares Mean (Standard Error)
Unit of Measure: Liters
0.073  (0.0248) -0.028  (0.0250)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QVA149 110/50 Micrograms, Salmeterol/Fluticasone 50/500 Micrograms
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.102
Confidence Interval (2-Sided) 95%
0.037 to 0.167
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Total Symptom Score- CAT (COPD Assessment Test)
Hide Description The participants will record their COPD symptoms in this test before every clinic visit, this will include : cough, phlegm, chest tightness, breathlessness, limitation in activities, energy, soundly sleep, etc. A higher score indicates a worse health status. The result is immediately available without the need for any calculation, apart from summing the scores on individual items. Scores of 0 - 10 represent mild, 11 - 20 represent moderate, 21 - 30 represent severe and 31 - 40 represent very severe clinical impact of COPD upon the patient.
Time Frame week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to
Arm/Group Title QVA149 110/50 Micrograms Salmeterol/Fluticasone 50/500 Micrograms
Hide Arm/Group Description:
QVA149 110/50 micrograms o.d. Capsules for inhalation
salmeterol/fluticasone 50/500 micrograms b.i.d. Dry inhalation powder
Overall Number of Participants Analyzed 248 250
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
13.4  (0.48) 13.8  (0.47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QVA149 110/50 Micrograms, Salmeterol/Fluticasone 50/500 Micrograms
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.319
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-1.3 to 0.4
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Mean Daily Use of Rescue Medication
Hide Description Use of rescue medication (number of puffs taken in the previous 12 hours) is recorded morning and evening, by the patient, in a paper diary. A negative change from baseline indicates an improvement.
Time Frame over 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to
Arm/Group Title QVA149 110/50 Micrograms Salmeterol/Fluticasone 50/500 Micrograms
Hide Arm/Group Description:
QVA149 110/50 micrograms o.d. Capsules for inhalation
salmeterol/fluticasone 50/500 micrograms b.i.d. Dry inhalation powder
Overall Number of Participants Analyzed 248 250
Least Squares Mean (Standard Error)
Unit of Measure: Number of puffs
1.05  (0.132) 1.09  (0.130)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QVA149 110/50 Micrograms, Salmeterol/Fluticasone 50/500 Micrograms
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.662
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.04
Confidence Interval (2-Sided) 95%
-0.20 to 0.13
Estimation Comments [Not Specified]
Time Frame All AEs starting on or after the time of first administration of double-blind study drug but not later than 7 days (30 days in the case of an SAE) after the last administration are included in the summaries
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title QVA149 Salm/Flut
Hide Arm/Group Description QVA149 110/50 micrograms o.d. Capsules for inhalation salmeterol/fluticasone 50/500 micrograms b.i.d. Dry inhalation powder
All-Cause Mortality
QVA149 Salm/Flut
Affected / at Risk (%) Affected / at Risk (%)
Total   1/248 (0.40%)   1/250 (0.40%) 
Show Serious Adverse Events Hide Serious Adverse Events
QVA149 Salm/Flut
Affected / at Risk (%) Affected / at Risk (%)
Total   9/248 (3.63%)   9/250 (3.60%) 
Cardiac disorders     
Acute myocardial infarction  1  0/248 (0.00%)  1/250 (0.40%) 
Atrial fibrillation  1  1/248 (0.40%)  0/250 (0.00%) 
Bundle branch block right  1  1/248 (0.40%)  0/250 (0.00%) 
Congenital, familial and genetic disorders     
Thalassaemia beta  1  1/248 (0.40%)  0/250 (0.00%) 
Eye disorders     
Cataract  1  0/248 (0.00%)  1/250 (0.40%) 
Entropion  1  0/248 (0.00%)  1/250 (0.40%) 
Gastrointestinal disorders     
Abdominal distension  1  0/248 (0.00%)  1/250 (0.40%) 
Abdominal pain upper  1  0/248 (0.00%)  1/250 (0.40%) 
Inguinal hernia  1  1/248 (0.40%)  0/250 (0.00%) 
General disorders     
Sudden death  1  1/248 (0.40%)  0/250 (0.00%) 
Hepatobiliary disorders     
Bile duct obstruction  1  0/248 (0.00%)  1/250 (0.40%) 
Hydrocholecystis  1  0/248 (0.00%)  1/250 (0.40%) 
Jaundice  1  0/248 (0.00%)  1/250 (0.40%) 
Infections and infestations     
Pneumonia  1  0/248 (0.00%)  1/250 (0.40%) 
Injury, poisoning and procedural complications     
Heat stroke  1  1/248 (0.40%)  0/250 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  0/248 (0.00%)  1/250 (0.40%) 
Rhabdomyolysis  1  1/248 (0.40%)  0/250 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neuroendocrine carcinoma metastatic  1  1/248 (0.40%)  0/250 (0.00%) 
Pancreatic carcinoma  1  0/248 (0.00%)  1/250 (0.40%) 
Nervous system disorders     
Cerebral infarction  1  1/248 (0.40%)  0/250 (0.00%) 
Ischaemic stroke  1  1/248 (0.40%)  0/250 (0.00%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  0/248 (0.00%)  1/250 (0.40%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  3/248 (1.21%)  3/250 (1.20%) 
Pneumonia aspiration  1  1/248 (0.40%)  0/250 (0.00%) 
Vascular disorders     
Penetrating aortic ulcer  1  1/248 (0.40%)  0/250 (0.00%) 
1
Term from vocabulary, MedDRA (20.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
QVA149 Salm/Flut
Affected / at Risk (%) Affected / at Risk (%)
Total   39/248 (15.73%)   50/250 (20.00%) 
Gastrointestinal disorders     
Dry mouth  1  0/248 (0.00%)  3/250 (1.20%) 
Infections and infestations     
Upper respiratory tract infection  1  6/248 (2.42%)  5/250 (2.00%) 
Viral upper respiratory tract infection  1  3/248 (1.21%)  4/250 (1.60%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  24/248 (9.68%)  31/250 (12.40%) 
Cough  1  6/248 (2.42%)  3/250 (1.20%) 
Dyspnoea  1  2/248 (0.81%)  6/250 (2.40%) 
Oropharyngeal pain  1  0/248 (0.00%)  3/250 (1.20%) 
Vascular disorders     
Hypertension  1  5/248 (2.02%)  2/250 (0.80%) 
1
Term from vocabulary, MedDRA (20.0)
Indicates events were collected by systematic assessment
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.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
EMail: novartis.email@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02516592     History of Changes
Other Study ID Numbers: CQVA149A3405
First Submitted: August 4, 2015
First Posted: August 6, 2015
Results First Submitted: April 23, 2018
Results First Posted: March 21, 2019
Last Update Posted: March 21, 2019