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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)

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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)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Jan 2022

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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

    • 24 Jul 2019 Results of pooled post hoc analysis of data from the ARISE (NCT01285492), SHINE (NCT01202188) and SPARK (NCT01120691) studies evaluating the efficacy of Indacaterol/glycopyrronium versus open label Tiotropium or glycopyrronium in COPD patients published in the Respirology
    • 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.

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