Phase 3
Completed N=357
Efficacy and Safety Study of QVA149 in COPD Patients
Source: ClinicalTrials.gov NCT02487446 ↗Enrolled (actual)
357
Serious AEs
6.5%
Results posted
Dec 2017
Primary outcomePrimary: Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h — 0.2321; 0.2436 Liters — p=0.139
◆ Published Evidence
Established
38citations · ~4 / year
Dual Bronchodilation with Indacaterol Maleate/Glycopyrronium Bromide Compared with Umeclidinium Bromide/Vilanterol in Patients with Moderate-to-Severe COPD: Results from Two Randomized, Controlled, Cross-over Studies.
Summary
The purpose of this study is to demonstrate that the efficacy of the combination product QVA149 is similar to the efficacy of the combination product umeclidinium/vilanterol on a pre-specified endpoint of FEV1 AUC0-24h while maintaining an acceptable safety profile.
Linked Publications
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Dual Bronchodilation with Indacaterol Maleate/Glycopyrronium Bromide Compared with Umeclidinium Bromide/Vilanterol in Patients with Moderate-to-Severe COPD: Results from Two Randomized, Controlled, Cross-over Studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h |
0.2321; 0.2436 | — |
| SECONDARY Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h |
0.2321; 0.2436 | — |
| SECONDARY Change From Baseline in Trough FEV1 (Mean of 23h 15 Minutes and 23 h 45 Minutes Post Previous Morning Dose) |
0.1891; 0.2043 | — |
| SECONDARY Change From Baseline in FEV1 AUC 12-24h |
0.2076; 0.2025 | — |
| SECONDARY Change From Baseline in FEV1 AUC 0-12h |
0.2543; 0.2848 | — |
| SECONDARY Change From Baseline in FEV1 AUC 0-4h, AUC 4-8h, AUC 8-12h, AUC 12-16h, AUC 16-20h and AUC 20-24h |
0.3223; 0.3289; 0.2399; 0.2831; 0.1911; 0.2411 | — |
| SECONDARY Change From Baseline in Pre-dose Trough FEV1 (Mean of 15 Minutes and 45 Minutes Pre Morning Dose) |
0.2302; 0.2450 | — |
| SECONDARY QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point |
0.1112; 0.1201; 0.1509; 0.1682; 0.1602; 0.1945 | — |
| SECONDARY QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point |
0.2177; 0.2218; 0.2566; 0.2927; 0.2811; 0.3325 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female adults aged ≥40 yrs
- Smoking history of at least 10 pack years
- Diagnosis of stable Chronic Obstructive Pulmonary Disease (COPD) as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2015)
- Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)< 80% and ≥ 30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) <70%
- Modified Medical Research Council questionnaire grade of 2 or higher
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 (NCT02487446) and the linked publication. 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.