Official Title: “A Multiple Dose Comparison of Tiotropium Inhalation Capsules and Salmeterol Inhalation Aerosol in a 12 Week, Randomized, Double-Blind, Double-Dummy Parallel Group Study in Patients With Chronic Obstructive Pulmonary Disease (COPD).”

To evaluate changes in PaO2 following inhalation of Tiotropium by HandiHaler compared to Salmeterol MDI in patients with moderate to severe COPD.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment

Intervention(s) in this Clinical Trial

• Drug: Tiotropium
• Drug: Salmeterol

Primary Measures

• The primary ctiterion for evaluation is change from baseline (Visit 2) in the PaO2 AUC for the time period 0 to105 min. obtained through ABGs at the end of each treatment period in patients with COPD.

Secondary Measures

• Maximum decline in PaO2 from (Visit 2) will be compared between treatment groups. PaO2. Maximum increase in alveolar-arterial oxygen gradient from Visit 2. Change from baseline (visit 2) FEV1 and FVC.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Boehringer Ingelheim Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Coordinator Study Chair Boehringer Ingelheim Pharmaceuticals  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00274534

Study ID Number: 205.234

ClinicalTrials.gov Identifier: NCT00274534

Health Authority: United States: Food and Drug Administration