QVA149 Versus Fluticasone/Salmeterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) (ILLUMINATE)
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
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
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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
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 | |
|---|---|---|---|
|
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
Show All Outcome Measures
| 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 ] |
| 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 ] |
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 |
| 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 ] |