A Multicener, Randomised, Double-blind, Placebo-controlled Study, to Assess the Long Term Safety of 52 Weeks Treatment With QVA149 (110 ug Indacaterol/50ug Glycopyrrolate) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Trial Profile

A Multicener, Randomised, Double-blind, Placebo-controlled Study, to Assess the Long Term Safety of 52 Weeks Treatment With QVA149 (110 ug Indacaterol/50ug Glycopyrrolate) 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)
  • Indications Chronic obstructive pulmonary disease
  • Focus Adverse reactions; Registrational
  • Acronyms ENLIGHTEN
  • Sponsors Novartis Pharmaceuticals
  • Most Recent Events

    • 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 Results for symptom scores presented at the 23rd Annual Congress of the European Respiratory Society.
    • 11 Sep 2013 Pooled tolerability analysis of the SHINE, ILLUMINATE, ENLIGHTEN and ARISE trials presented at the 23rd Annual Congress of the European Respiratory Society.
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