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

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ClinicalTrials.gov Identifier: NCT01315249
Recruitment Status : Completed
First Posted : March 15, 2011
Results First Posted : August 9, 2013
Last Update Posted : August 9, 2013
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: 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

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

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 
Overall Participants Analyzed 
[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

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

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

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 ]
  Show Outcome Measure 3

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 ]
  Hide Outcome Measure 4

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  

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 
Participants Analyzed   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 ]
  Show Outcome Measure 5

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

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

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  More Information