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Clinical trial

Efficacy and Safety Study of Indacaterol Maleate/Glycopyrronium Bromide in Chronic Obstructive Pulmonary Disease (COPD) Patients.

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Last updated:27th Jul 2015
Identifier: NCT02487498

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: 355 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, Two-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 27, 2015
Primary Completion Date: September 6, 2016
Study Completion Date: September 6, 2016

Arms and Interventions:
- Experimental:
QVA149
- Active Comparator: Umeclidinium/vilanterol



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 2017-04-27
Study type(s) Interventional
Expected enrolment 355
Study start date 2015-07-27
Estimated primary completion date 2016-09-06

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