A Comparison of the Effects of Tiotropium Inhalation qd and Salmeterol Inhalation Bid on Arterial Blood Gases.
To evaluate changes in PaO2 following inhalation of Tiotropium by HandiHaler compared to Salmeterol MDI in patients with moderate to severe COPD...
Brief Summary
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: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Tiotropium
- Drug: Salmeterol
Outcome Measures for this Clinical Trial
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.
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Boehringer Ingelheim Pharmaceuticals Industry
Overall Clinical Trial Officials and Contacts
Boehringer Ingelheim Study Coordinator Study Chair Boehringer Ingelheim Pharmaceuticals
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00274534
