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.
Phase of Trial: Phase III
Latest Information Update: 04 Apr 2018
At a glance
- Drugs Glycopyrrolate/indacaterol (Primary) ; Umeclidinium/vilanterol
- Indications Chronic obstructive pulmonary disease
- Focus Registrational; Therapeutic Use
- Sponsors Novartis
- 29 Mar 2017 Status changed from recruiting to completed.
- 21 Dec 2016 Primary endpoint has not been met. (To demonstrate non-inferiority of QVA149 compared to umeclidinium/vilanterol in terms of FEV1 AUC 0-24h), as reported in a Novartis media release.
- 21 Dec 2016 According to a Novartis media release, full evaluation of the trial data is ongoing and will be communicated in due course.