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Clinical trial

Efficacy and Safety Study of QVA149 in COPD Patients

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Last updated:28th Jul 2015
Identifier: NCT02487446

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

Related journal:
- 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.

Category Value
Date last updated at source 2017-12-26
Study type(s) Interventional
Expected enrolment 357
Study start date 2015-07-28
Estimated primary completion date 2016-09-12

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