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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)

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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)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Jan 2022

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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; Novartis Healthcare; Novartis Pharmaceuticals

Most Recent Events

  • 10 Jan 2022 New source identified and integrated (Japan Pharmaceutical Information Center - Clinical Trials Information record: JapicCTI111408).
  • 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
  • 18 Jul 2019 This trial has been completed in United Kingdom, according to European Clinical Trials Database.

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