Phase 3
Completed N=193
Comparison of Safety and Efficacy of the Combination Product QVA149A Against the Concurrent Administration of the Individual Components, QAB149 and NVA237, in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Source: ClinicalTrials.gov NCT01529632 ↗Enrolled (actual)
193
Serious AEs
5.2%
Results posted
Feb 2014
Primary outcomePrimary: Trough Forced Expiratory Volume in 1 Second (FEV1) After 28 Days of Blinded Treatment — 1.459; 1.465 Liters
Summary
The study assessed the safety and efficacy of the fixed combination product QVA149 versus the component products QAB149 and NVA237, administered concurrently, in patients that have moderate to severe chronic obstructive pulmonary disease (COPD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trough Forced Expiratory Volume in 1 Second (FEV1) After 28 Days of Blinded Treatment |
1.459; 1.465 | — |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-4 Hours at Day 1 |
1.597; 1.573 | — |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-4 Hours at Day 28 |
1.575; 1.587 | — |
| SECONDARY Peak Forced Expiratory Volume in 1 Second (FEV1) on Days 1 and 28 Post-dose |
1.668; 1.646; 1.643; 1.654 | — |
| SECONDARY Time Course of Forced Expiratory Volume in One Second (FEV1) (Pre-dose to 4 Hours Post Dose) on Day 28 |
1.452; 1.460; 1.449; 1.430; 1.491; 1.514 | — |
| SECONDARY Change From Baseline in the Mean Daily, (Daytime and Nighttime Combined) Number of Puffs of Rescue Medication Used Over 28 Days of Treatment |
2.24; 2.04; 1.85; 1.70 | — |
| SECONDARY Change From Baseline in Percentage of Days With 'no Daytime Symptoms' Over 28 Days of Treatment |
6.2; 3.9; 9.3; 6.0 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female adults aged ≥ 40 yrs
- Smoking history of at least 10 pack years
- Diagnosis of COPD (moderate to severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2010)
- Post-bronchodilator FEV1 < 80% and ≥ 30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) < 70%
Exclusion Criteria
- Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1
- Patients with concomitant pulmonary disease
- Patients with a history of asthma
- Any patient with lung cancer or a history of lung cancer
- Patients with a history of certain cardiovascular co-morbid conditions
- Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
- Patients in the active phase of a supervised pulmonary rehabilitation program
- Patients contraindicated for inhaled anticholinergic agents and β2 agonists
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01529632). 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. Informational only — not medical advice.