Efficacy and Safety Study of QVA149 in COPD Patients

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.


Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 357 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date: July 28, 2015
Primary Completion Date: September 12, 2016
Study Completion Date: September 12, 2016

Arms and Interventions:
- Experimental: First QVA149, then Umeclidinium/vilanterol
- Experimental: First Umeclidinium/vilanterol, then QVA149