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.

Trial Profile

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.

Completed
Phase of Trial: Phase III

Latest Information Update: 02 May 2017

At a glance

  • Drugs Glycopyrrolate/indacaterol (Primary) ; Umeclidinium/vilanterol
  • Indications Chronic obstructive pulmonary disease
  • Focus Registrational; Therapeutic Use
  • Sponsors Novartis
  • Most Recent Events

    • 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.
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