Phase 3
Completed N=355
Efficacy and Safety Study of Indacaterol Maleate/Glycopyrronium Bromide in Chronic Obstructive Pulmonary Disease (COPD) Patients.
Source: ClinicalTrials.gov NCT02487498 ↗Enrolled (actual)
355
Serious AEs
5.1%
Results posted
Apr 2018
Primary outcomePrimary: Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h — 0.1846; 0.2028 Liters — p=0.415
◆ 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 |
0.1846; 0.2028 | — |
| SECONDARY Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h |
0.1846; 0.2028 | — |
| SECONDARY Superiority of QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Trough FEV1 (Mean of 23h 15 Minutes and 23 h 45 Minutes Post Previous Morning Dose) |
0.1676; 0.1767 | — |
| SECONDARY Change From Baseline in FEV1 AUC 12-24h |
0.1625; 0.1539 | — |
| SECONDARY Change From Baseline in FEV1 AUC 0-12h |
0.2077; 0.2496 | — |
| 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 |
0.2663; 0.2938; 0.1970; 0.2519; 0.1513; 0.2015 | — |
| SECONDARY QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Pre-dose Trough FEV1 (Mean of 15 Minutes and 45 Minutes Pre Morning Dose) |
0.1827; 0.2043 | — |
| SECONDARY QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point |
0.1134; 0.1117; 0.1448; 0.1591; 0.1630; 0.1836 | — |
| SECONDARY QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point |
0.1994; 0.2054; 0.2454; 0.2589; 0.2734; 0.3028 | — |
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 (NCT02487498) 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.