QVA149 Versus Fluticasone/Salmeterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) (ILLUMINATE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01315249
First received: March 11, 2011
Last updated: July 9, 2013
Last verified: July 2013
Results First Received: February 28, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease (COPD)
Interventions: Drug: indacaterol and glycopyrronium (QVA149)
Drug: Placebo to fluticasone/salmeterol
Drug: fluticasone/salmeterol
Drug: Placebo to indacaterol and glycopyrronium (QVA149)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All eligible patients were randomized to one of the 2 arms in a 1:1 ratio for 26 weeks of treatment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 523 patients were randomized. A total of 522 patients (99.8%) were included in the Full analysis Set (FAS) and Safety set. One patient was excluded who was randomized in error and did not receive study medication.

Reporting Groups
  Description
QVA149 Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
Fluticasone/Salmeterol Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).

Participant Flow:   Overall Study
    QVA149     Fluticasone/Salmeterol  
STARTED     259     264  
COMPLETED     215     217  
NOT COMPLETED     44     47  
Adverse Event                 22                 26  
Withdrawal by Subject                 11                 10  
Protocol Violation                 8                 5  
Abnormal test results                 1                 2  
Administrative problems                 1                 0  
inability to use device                 1                 0  
Lack of Efficacy                 0                 1  
Lost to Follow-up                 0                 2  
Death                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
QVA149 Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
Fluticasone/Salmeterol Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
Total Total of all reporting groups

Baseline Measures
    QVA149     Fluticasone/Salmeterol     Total  
Number of Participants  
[units: participants]
  258     264     522  
Age  
[units: years]
Mean ± Standard Deviation
  63.2  ± 8.16     63.4  ± 7.71     63.3  ± 7.93  
Gender  
[units: participants]
     
Female     77     75     152  
Male     181     189     370  



  Outcome Measures
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1.  Primary:   Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12   [ Time Frame: Week 26 ]

Measure Type Primary
Measure Title Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12
Measure Description Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. FEV1 was normalized by 12 hours (divided by time). This outcome measures absolute values at week 26. Results are obtained from linear mixed model.
Time Frame Week 26  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Full Analysis Set (FAS) included all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.

Reporting Groups
  Description
QVA149 Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
Fluticasone/Salmeterol Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).

Measured Values
    QVA149     Fluticasone/Salmeterol  
Number of Participants Analyzed  
[units: participants]
  212     216  
Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12  
[units: liters]
Least Squares Mean ± Standard Error
  1.69  ± 0.027     1.56  ± 0.026  

No statistical analysis provided for Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12



2.  Secondary:   Standardized Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 Hours   [ Time Frame: Week 12 ]

Measure Type Secondary
Measure Title Standardized Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 Hours
Measure Description Standardized Forced Expiratory Volume in 1 Second (FEV1) was measured with spirometry conducted according to internationally accepted standards. Measurements were made between 0 and 12 hours after treatment. FEV1 was normalized by 12 hours (divided by time). This outcome measures absolute values at week 12. Results are obtained from linear mixed model.
Time Frame Week 12  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.

Reporting Groups
  Description
QVA149 Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
Fluticasone/Salmeterol Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).

Measured Values
    QVA149     Fluticasone/Salmeterol  
Number of Participants Analyzed  
[units: participants]
  255     261  
Standardized Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 Hours  
[units: liters]
Least Squares Mean ± Standard Error
  1.71  ± 0.023     1.59  ± 0.022  

No statistical analysis provided for Standardized Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 Hours



3.  Secondary:   Forced Vital Capacity at All-time Points (Week 12)   [ Time Frame: -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 12 ]

Measure Type Secondary
Measure Title Forced Vital Capacity at All-time Points (Week 12)
Measure Description

Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.

This outcome measures absolute values at -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose week 12. Results are obtained from linear mixed model.

Time Frame -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 12  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.

Reporting Groups
  Description
QVA149 Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
Fluticasone/Salmeterol Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).

Measured Values
    QVA149     Fluticasone/Salmeterol  
Number of Participants Analyzed  
[units: participants]
  230     237  
Forced Vital Capacity at All-time Points (Week 12)  
[units: liters]
Least Squares Mean ± Standard Error
   
-45 minutes (n=230 QVA149; 237 flut/salm)     3.37  ± 0.046     3.16  ± 0.044  
-15 minutes (n=228 QVA149; 235 flut/salm)     3.37  ± 0.047     3.17  ± 0.045  
5 minutes (n=229 QVA149; 236 flut/salm)     3.44  ± 0.048     3.20  ± 0.046  
30 minutes (n=229 QVA149; 235 flut/salm)     3.48  ± 0.048     3.23  ± 0.046  
1 hour (n=228 QVA149; 236 flut/salm)     3.49  ± 0.049     3.26  ± 0.047  
2 hours (n=229 QVA149; 237 flut/salm)     3.54  ± 0.048     3.31  ± 0.046  
4 hours (n=228 QVA149; 237 flut/salm)     3.49  ± 0.050     3.33  ± 0.048  
8 hours (n=228 QVA149; 237 flut/salm)     3.46  ± 0.048     3.27  ± 0.046  
12 hours (n=228 QVA149; 236 flut/salm)     3.45  ± 0.050     3.26  ± 0.049  

No statistical analysis provided for Forced Vital Capacity at All-time Points (Week 12)



4.  Secondary:   Forced Vital Capacity at All-time Points (Week 26)   [ Time Frame: -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 26 ]

Measure Type Secondary
Measure Title Forced Vital Capacity at All-time Points (Week 26)
Measure Description

Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.

This outcome measures absolute values at -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 26. Results are obtained from linear mixed model.

Time Frame -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 26  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.

Reporting Groups
  Description
QVA149 Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
Fluticasone/Salmeterol Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).

Measured Values
    QVA149     Fluticasone/Salmeterol  
Number of Participants Analyzed  
[units: participants]
  213     216  
Forced Vital Capacity at All-time Points (Week 26)  
[units: liters]
Least Squares Mean ± Standard Error
   
-45 minutes (n=213 QVA149; 216 flut/salm)     3.32  ± 0.047     3.13  ± 0.045  
-15 minutes (n=213 QVA149; 215 flut/salm)     3.33  ± 0.044     3.12  ± 0.043  
5 minutes (n=212 QVA149; 215 flut/salm)     3.42  ± 0.051     3.17  ± 0.049  
30 minutes (n=212 QVA149; 214 flut/salm)     3.47  ± 0.053     3.23  ± 0.051  
1 hour (n=212 QVA149; 216 flut/salm)     3.50  ± 0.051     3.23  ± 0.049  
2 hours (n=212 QVA149; 216 flut/salm)     3.51  ± 0.051     3.29  ± 0.049  
4 hours (n=212 QVA149; 215 flut/salm)     3.45  ± 0.053     3.28  ± 0.050  
8 hours (n=212 QVA149; 216 flut/salm)     3.40  ± 0.053     3.21  ± 0.050  
12 hours (n=211 QVA149; 213 flut/salm)     3.40  ± 0.053     3.18  ± 0.051  

No statistical analysis provided for Forced Vital Capacity at All-time Points (Week 26)



5.  Secondary:   Focal Score of the Transitional Dyspnea Index (TDI)   [ Time Frame: 12 weeks and 26 weeks ]

Measure Type Secondary
Measure Title Focal Score of the Transitional Dyspnea Index (TDI)
Measure Description Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement.
Time Frame 12 weeks and 26 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.

Reporting Groups
  Description
QVA149 Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
Fluticasone/Salmeterol Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).

Measured Values
    QVA149     Fluticasone/Salmeterol  
Number of Participants Analyzed  
[units: participants]
  224     236  
Focal Score of the Transitional Dyspnea Index (TDI)  
[units: units on a scale]
Least Squares Mean ± Standard Error
   
12 weeks (n=224 QVA149; 236 flut/salm)     2.03  ± 0.388     1.45  ± 0.374  
26 weeks (n=212 QVA149; 213 flut/salm)     2.36  ± 0.388     1.60  ± 0.376  

No statistical analysis provided for Focal Score of the Transitional Dyspnea Index (TDI)



6.  Secondary:   Total Score of the St. George's Respiratory Questionnaire (SGRQ-C)   [ Time Frame: 12 weeks and 26 weeks ]

Measure Type Secondary
Measure Title Total Score of the St. George's Respiratory Questionnaire (SGRQ-C)
Measure Description The total score of the St. George's Respiratory Questionnaire (SGRQ-C) is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life.
Time Frame 12 weeks and 26 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.

Reporting Groups
  Description
QVA149 Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
Fluticasone/Salmeterol Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).

Measured Values
    QVA149     Fluticasone/Salmeterol  
Number of Participants Analyzed  
[units: participants]
  230     238  
Total Score of the St. George's Respiratory Questionnaire (SGRQ-C)  
[units: units on a scale]
Least Squares Mean ± Standard Error
   
12 weeks (n=230 QVA149; 238 flut/salm)     36.74  ± 1.175     36.03  ± 1.132  
26 weeks (n=211 QVA149; 216 flut/salm)     35.45  ± 1.448     36.68  ± 1.386  

No statistical analysis provided for Total Score of the St. George's Respiratory Questionnaire (SGRQ-C)



7.  Secondary:   Mean Change From Baseline in Daily Number of Puffs of Rescue Medication   [ Time Frame: Baseline, 12 weeks and 26 weeks ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Daily Number of Puffs of Rescue Medication
Measure Description Participants maintained a diary to record the daily number of puffs of rescue medication used to treat COPD symptoms.
Time Frame Baseline, 12 weeks and 26 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.

Reporting Groups
  Description
QVA149 Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
Fluticasone/Salmeterol Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).

Measured Values
    QVA149     Fluticasone/Salmeterol  
Number of Participants Analyzed  
[units: participants]
  253     259  
Mean Change From Baseline in Daily Number of Puffs of Rescue Medication  
[units: puffs]
Least Squares Mean ± Standard Error
   
Weeks 1 to12     -2.18  ± 0.187     -1.90  ± 0.184  
Weeks 1 to 26     -2.32  ± 0.194     -1.93  ± 0.191  

No statistical analysis provided for Mean Change From Baseline in Daily Number of Puffs of Rescue Medication



8.  Secondary:   Change From Baseline in Symptom Scores Reported Using the Ediary   [ Time Frame: 12 weeks and 26 weeks ]

Measure Type Secondary
Measure Title Change From Baseline in Symptom Scores Reported Using the Ediary
Measure Description

Participants maintained an ediary to record daily symptom scores (AM and PM) over 12 weeks and 26 weeks of treatment. This analysis compares the mean symptom scores over 12 weeks and 26 weeks compared to baseline. The diary records morning and evening daily clinical symptoms including cough, wheezing, shortness of breath, sputum volume, sputum purulence, night time awakenings and rescue medication use.

Scale ranges: ranges are 0 to 3 with varying scale descriptions that pertain to the question being asked.

0 is the minimum score = “none” or “No symptoms” or “never” or “No”

  1. = mild, a little
  2. = moderate
  3. = severe For the scale range provided, high values represent a worse outcome.
Time Frame 12 weeks and 26 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.

Reporting Groups
  Description
QVA149 Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
Fluticasone/Salmeterol Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).

Measured Values
    QVA149     Fluticasone/Salmeterol  
Number of Participants Analyzed  
[units: participants]
  253     259  
Change From Baseline in Symptom Scores Reported Using the Ediary  
[units: units on a scale]
Least Squares Mean ± Standard Error
   
Weeks 1-12     -1.08  ± 0.135     -1.17  ± 0.133  
Weeks 1-26     -1.28  ± 0.140     -1.24  ± 0.138  

No statistical analysis provided for Change From Baseline in Symptom Scores Reported Using the Ediary



9.  Secondary:   Inspiratory Capacity (IC) at All-time Points (12 Weeks)   [ Time Frame: 12 weeks ]

Measure Type Secondary
Measure Title Inspiratory Capacity (IC) at All-time Points (12 Weeks)
Measure Description After 12 weeks of treatment, Inspiratory Capacity (IC) was measured via spirometry, conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters.
Time Frame 12 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Inspiratory capacity was measured for a subset of patients QVA149 group: (78 patients (30.2%)) at baseline and 49-73 patients contributing observations at post-baseline visits.

flut/salm group: (86 patients (32.6%)) at baseline and 60-79 patients contributing observations at post-baseline visits.


Reporting Groups
  Description
QVA149 Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
Fluticasone/Salmeterol Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).

Measured Values
    QVA149     Fluticasone/Salmeterol  
Number of Participants Analyzed  
[units: participants]
  58     72  
Inspiratory Capacity (IC) at All-time Points (12 Weeks)  
[units: Liters]
Least Squares Mean ± Standard Error
   
-20 minutes (n=51 QVA149; 65 flut/salm)     2.39  ± 0.081     2.31  ± 0.073  
25 minutes (n=56 QVA149; 71 flut/salm)     2.55  ± 0.075     2.42  ± 0.068  
1 hour (n=59 QVA149; 68 flut/salm)     2.54  ± 0.079     2.43  ± 0.072  
3 hours (n=54 QVA149; 67 flut/salm)     2.52  ± 0.086     2.45  ± 0.079  
7 hours (n=58 QVA149; 67 flut/salm)     2.42  ± 0.080     2.41  ± 0.073  
11 hours (n=49 QVA149; 72 flut/salm)     2.40  ± 0.079     2.34  ± 0.070  

No statistical analysis provided for Inspiratory Capacity (IC) at All-time Points (12 Weeks)



10.  Secondary:   Inspiratory Capacity (IC) at All-time Points (26 Weeks)   [ Time Frame: 26 weeks ]

Measure Type Secondary
Measure Title Inspiratory Capacity (IC) at All-time Points (26 Weeks)
Measure Description After 26 weeks of treatment, Inspiratory Capacity (IC) was measured via spirometry, conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters.
Time Frame 26 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Inspiratory capacity was measured for a subset of patients QVA149 group: (78 patients (30.2%)) at baseline and 49-73 patients contributing observations at post-baseline visits.

flut/salm group: (86 patients (32.6%)) at baseline and 60-79 patients contributing observations at post-baseline visits.


Reporting Groups
  Description
QVA149 Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
Fluticasone/Salmeterol Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).

Measured Values
    QVA149     Fluticasone/Salmeterol  
Number of Participants Analyzed  
[units: participants]
  58     66  
Inspiratory Capacity (IC) at All-time Points (26 Weeks)  
[units: Liters]
Least Squares Mean ± Standard Error
   
-20 minutes (n=53 QVA149; 63 flut/salm)     2.25  ± 0.079     2.22  ± 0.071  
25 minutes (n=58 QVA149; 63 flut/salm)     2.41  ± 0.088     2.34  ± 0.080  
1 hour (n=53 QVA149; 63 flut/salm)     2.38  ± 0.087     2.35  ± 0.079  
3 hours (n=52 QVA149; 60 flut/salm)     2.33  ± 0.090     2.32  ± 0.080  
7 hours (n=56 QVA149; 61 flut/salm)     2.40  ± 0.82     2.30  ± 0.075  
11 hours (n=57 QVA149; 66 flut/salm)     2.37  ± 0.084     2.27  ± 0.075  

No statistical analysis provided for Inspiratory Capacity (IC) at All-time Points (26 Weeks)



11.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 26 weeks ]

Measure Type Secondary
Measure Title Number of Participants With Adverse Events
Measure Description The assessment of safety was based on Adverse Events. A summary of adverse events is presented with this outcome, additional details are provided in Adverse Events Section.
Time Frame 26 weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety set includes all participants who received at least one dose of study drug.

Reporting Groups
  Description
QVA149 Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
Fluticasone/Salmeterol Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).

Measured Values
    QVA149     Fluticasone/Salmeterol  
Number of Participants Analyzed  
[units: participants]
  258     264  
Number of Participants With Adverse Events  
[units: participants]
   
Any Adverse Event     143     159  
Death     0     1  
Serious Adverse Events     13     14  
Discontinued due to Adverse Events     22     27  
Discontinued due to Serious Adverse Events     5     9  
Discontinued due to non-Serious Adverse Events     17     18  

No statistical analysis provided for Number of Participants With Adverse Events




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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