Phase 3
N=85
Effect of QVA149 on Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease (COPD)
COPD
Bottom Line
View on ClinicalTrials.gov: NCT01294787 ↗Enrolled (actual)
85
Serious AEs
1.3%
Results posted
Mar 2013
Primary outcome: Primary: Exercise Tolerance Comparison Between QVA149 and Placebo Groups — 507.8; 448.3 Seconds
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- indacaterol and glycopyrronium bromide (QVA149) (Drug); placebo (Drug); tiotropium (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Exercise Tolerance Comparison Between QVA149 and Placebo Groups |
507.8; 448.3 | — |
| SECONDARY Dynamic Inspiratory Capacity Comparison Between QVA149 and Placebo Groups |
2.42; 2.29; 2.11 | — |
| SECONDARY Trough 24 Hour Post Dose Inspiratory Capacity Comparison Between QVA149 and Placebo Groups |
2.25; 2.10; 2.06 | — |
| SECONDARY Trough 24 Hour Post Dose Forced Expiratory Volume in One Second Comparison Between QVA149 and Placebo Groups |
1.53; 1.43; 1.33 | — |
| SECONDARY Pulmonary Function Test Comparison Between QVA149 and Placebo Groups |
3.37; 3.22; 3.14; 3.43; 3.32; 3.16 | — |
| SECONDARY Pulmonary Function Test (RV) Comparison Between QVA149 and Placebo Groups |
3.66; 3.89; 3.94; 3.63; 3.66; 3.89 | — |
| SECONDARY Pulmonary Function Test (SGaw) Comparison Between QVA149 and Placebo Groups |
0.71; 0.58; 0.50; 0.71; 0.79; 0.50 | — |
| SECONDARY Pulmonary Function Test (FRC) Comparison Between QVA149 and Placebo Groups |
4.68; 4.78; 4.98; 4.62; 4.63; 4.92 | — |
| SECONDARY Spirometry After Three Weeks of Treatment on Patients Not Exercising |
2.34; 2.19; 2.01 | — |
| SECONDARY Exertional Dyspnea Comparison Between QVA149 and Placebo Groups |
3.77; 3.59; 3.87 | — |
| SECONDARY Leg Discomfort During Exercise Comparison Between QVA149 and Placebo Groups |
4.53; 4.57; 4.43 | — |
| SECONDARY Exercise Endurance Comparison Between QVA149 and Tiotropium Groups |
507.8; 514 | — |
| SECONDARY Exercise Endurance Time Comparison After a Single Dose of QVA149 Versus Placebo |
492.8; 481.0; 468.8 | — |
Summary
This study assessed the effect of once-daily indacaterol and glycopyrronium bromide (QVA149) on exercise endurance in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).
Eligibility Criteria
Inclusion Criteria
- Diagnosis of moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD) stage II or stage III according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines (2009)
- Qualifying spirometry, Forced Expiratory Volume in one second (FEV1) and post-bronchodilator FEV1/FVC (Forced Vital capacity)
- Smoking history ≥ 10 pack years
Exclusion Criteria
- Pregnant women or nursing mothers or women of child-bearing potential not using adequate contraception
- Cardiac abnormality
- History of asthma
- Contraindications to cardiopulmonary exercise testing
- Participation in active phase of pulmonary rehabilitation program
- History of cancer within the past 5 years
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01294787). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.