A Randomised, Phase II, Double-Blind, Double-Dummy, Four-period Crossover Efficacy and Safety Comparison of 4-Week Treatment Periods of Blinded Fluticasone (500 mcg Bid, MDI), Ciclesonide (400 mcg qd, MDI), Ciclesonide (800 mcg qd, MDI) or Placebo in Free Combination With Open-Label Tiotropium (18 mcg qd, HandiHaler) and Salmeterol (50 mcg Bid, Diskus) in Patients With COPD.

Trial Profile

A Randomised, Phase II, Double-Blind, Double-Dummy, Four-period Crossover Efficacy and Safety Comparison of 4-Week Treatment Periods of Blinded Fluticasone (500 mcg Bid, MDI), Ciclesonide (400 mcg qd, MDI), Ciclesonide (800 mcg qd, MDI) or Placebo in Free Combination With Open-Label Tiotropium (18 mcg qd, HandiHaler) and Salmeterol (50 mcg Bid, Diskus) in Patients With COPD.

Completed
Phase of Trial: Phase II

Latest Information Update: 30 Oct 2014

At a glance

  • Drugs Tiotropium bromide (Primary) ; Ciclesonide; Fluticasone propionate; Salmeterol
  • Indications Chronic obstructive pulmonary disease
  • Focus Therapeutic Use
  • Sponsors Boehringer Ingelheim
  • Most Recent Events

    • 29 May 2014 The number of treatment arms changed from 3 (Tiotropium, Salmeterol and Steroid) to 4. Now the treatment arm consist of Tiotropium+salmeterol+fluticasone,Tiotropium+salmeterol+ciclesonide low,Tiotropium+salmeterol+ciclesonide high and placebo.
    • 14 Oct 2008 Actual start date changed from Nov 2007 to Oct 2007 as reported by ClinicalTrials.gov.
    • 14 Oct 2008 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
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