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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Ciclesonide; Fluticasone; Salmeterol Xinafoate; Tiotropium Bromide

Criteria

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