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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 ]

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

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 ]
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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 ]

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

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

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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