A randomized, double-blind, double-dummy, active (formoterol 12 microg b.i.d. [twice daily]) and placebo controlled, multi-center, 5 period crossover study to assess the bronchodilatory efficacy and safety of single doses of indacaterol 150 microg, 300 microg and 600 microg delivered via single dose dry powder inhaler versus placebo in patients with moderate to severe COPD [chronic obstructive pulmonary disease].

Trial Profile

A randomized, double-blind, double-dummy, active (formoterol 12 microg b.i.d. [twice daily]) and placebo controlled, multi-center, 5 period crossover study to assess the bronchodilatory efficacy and safety of single doses of indacaterol 150 microg, 300 microg and 600 microg delivered via single dose dry powder inhaler versus placebo in patients with moderate to severe COPD [chronic obstructive pulmonary disease].

Completed
Phase of Trial: Phase II/III

Latest Information Update: 24 Oct 2011

At a glance

  • Drugs Formoterol; Indacaterol
  • Indications Chronic obstructive pulmonary disease
  • Focus Pharmacodynamics; Registrational; Therapeutic Use
  • Sponsors Novartis
  • Most Recent Events

    • 24 Oct 2011 Actual end date (January 2007) added as reported by ClinicalTrials.gov.
    • 07 Oct 2008 Results were reported at the Annual Congress of the European Respiratory Society.
    • 07 Oct 2008 Secondary endpoint 'Forced vital capacity' has been met.
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