A 52-week Treatment, Multi-center, Randomized, Open Label, Parallel Group Study to Assess the Long Term Safety and Tolerability of QVA149 (110 Mcg Indacaterol / 50 Mcg Glycopyrrolate o.d.) Using Tiotropium (18 Mcg o.d.) as an Active Control in Japanese Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Trial Profile

A 52-week Treatment, Multi-center, Randomized, Open Label, Parallel Group Study to Assess the Long Term Safety and Tolerability of QVA149 (110 Mcg Indacaterol / 50 Mcg Glycopyrrolate o.d.) Using Tiotropium (18 Mcg o.d.) as an Active Control in Japanese 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) ; Tiotropium bromide
  • Indications Chronic obstructive pulmonary disease
  • Focus Adverse reactions
  • Acronyms ARISE
  • Sponsors Novartis; 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 Pooled analysis assessing lung function 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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