A 26-week Treatment Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled (Open Label) Study to Assess the Efficacy, Safety and Tolerability of QVA149 (110/50 μg q.d.) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Trial Profile

A 26-week Treatment Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled (Open Label) Study to Assess the Efficacy, Safety and Tolerability of QVA149 (110/50 μg q.d.) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Completed
Phase of Trial: Phase III

Latest Information Update: 07 Sep 2016

At a glance

  • Drugs Glycopyrrolate/indacaterol (Primary) ; Glycopyrrolate; Indacaterol; Tiotropium bromide
  • Indications Chronic obstructive pulmonary disease
  • Focus Registrational; Therapeutic Use
  • Acronyms GLEAM; SHINE
  • Sponsors Novartis Pharmaceuticals
  • Most Recent Events

    • 06 Apr 2016 Results of pooled analysis of 3 trials (NCT01727141, NCT01712516, NCT01202188) published in the International Journal of Clinical Pharmacology and Therapeutics
    • 23 Sep 2013 Results from this trial contributed to the approval of glycopyrrolate/indacaterol, delivered via the Ultibro Breezhaler, by the European Commission according to a Vectura Group media release.
    • 11 Sep 2013 Pooled analysis presented at the 23rd Annual Congress of the European Respiratory Society.
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