Efficacy and Safety Study of QVA149 in COPD Patients
Status: | Completed |
---|---|
Conditions: | Chronic Obstructive Pulmonary Disease, Pulmonary |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 40 - Any |
Updated: | 12/27/2017 |
Start Date: | July 28, 2015 |
End Date: | September 12, 2016 |
A Multi-center, Randomized, Double-blind, Double-dummy, Active Controlled, 2-period Cross-over Study to Assess the Efficacy, Safety and Tolerability of Indacaterol Maleate/Glycopyrronium Bromide Compared to Umeclidinium Bromide/Vilanterol in COPD Patients With Moderate to Severe Airflow Limitation
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.
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.
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
We found this trial at
59
sites
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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