A Phase III Randomized, Double Blind, Double Dummy, Placebo Controlled, Multicenter, 4 Treatments, 3 Period Incomplete Block Crossover Study to Assess the Efficacy and Safety of Indacaterol 300 micrograms o.d. [once daily] Dosed in the Evening in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Salmeterol 50 micrograms b.i.d. [twice daily] as Active Control.

Trial Profile

A Phase III Randomized, Double Blind, Double Dummy, Placebo Controlled, Multicenter, 4 Treatments, 3 Period Incomplete Block Crossover Study to Assess the Efficacy and Safety of Indacaterol 300 micrograms o.d. [once daily] Dosed in the Evening in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Salmeterol 50 micrograms b.i.d. [twice daily] as Active Control.

Completed
Phase of Trial: Phase III

Latest Information Update: 27 Apr 2015

At a glance

  • Drugs Indacaterol (Primary) ; Salmeterol
  • Indications Chronic obstructive pulmonary disease
  • Focus Registrational; Therapeutic Use
  • Sponsors Novartis
  • Most Recent Events

    • 23 Jun 2012 Company added in the association field as reported by EudraCT.
    • 12 May 2012 Planned number of patients changed from 78 to 80 as reported by European Clinical Trials Database record.
    • 16 Sep 2010 Results published in Respiratory Medicine.
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