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A 52-week treatment, multicenter, randomized, double-blind, double dummy, placebo-controlled, parallel-group study to assess the efficacy, safety and tolerability of indacaterol (300 and 600 microg o.d.) in patients with chronic obstructive pulmonary disease, using formoterol (12 microg b.i.d.) as an active control

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Trial Profile

A 52-week treatment, multicenter, randomized, double-blind, double dummy, placebo-controlled, parallel-group study to assess the efficacy, safety and tolerability of indacaterol (300 and 600 microg o.d.) in patients with chronic obstructive pulmonary disease, using formoterol (12 microg b.i.d.) as an active control

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Aug 2019

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At a glance

  • Drugs Indacaterol (Primary) ; Formoterol
  • Indications Chronic obstructive pulmonary disease
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms INVOLVE
  • Sponsors Novartis
  • Most Recent Events

    • 31 Jul 2019 This trial has been completed in United Kingdom, according to European Clinical Trials Database.
    • 24 May 2017 Results (n=8445) of a pooled analysis from 11 Phase III/IIIb indacaterol studies assessing the efficacy and safety of once-daily indacaterol 150 and 300 ug in elderly patients with moderate to severe COPD, published in the Respiratory Medicine.
    • 01 Jun 2010 1-year results have been published in Thorax.
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