Efficacy and Safety Comparison of Steroid or Placebo in Combination With Salmeterol and Tiotropium in COPD

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.

This efficacy and safety study compares four different combinations of blinded inhaled steroid treatments on top of open-label tiotropium and salmeterol in patients with chronic obstructive pulmonary disease (COPD). The primary objective is the effect on lung function parameters.

Inclusion Criteria:

• Relatively stable, moderate to severe COPD
• Male or female patients 40 years of age or older.
• Current or ex-smokers with a smoking history of more than 10 pack years

Exclusion Criteria:

• Other significant disease that can influence the study results or be a safety risk for the patient
• Other medication that can influence the study results
• Hypersensitivity to the study medication
• Patients with unstable COPD