A Comparison of the Effects of Tiotropium Inhalation qd and Salmeterol Inhalation Bid on Arterial Blood Gases.
Phase 3
Completed
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Registration Number
- NCT00274534
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
To evaluate changes in PaO2 following inhalation of Tiotropium by HandiHaler compared to Salmeterol MDI in patients with moderate to severe COPD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Not specified
- Target Recruitment
- 36
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method The change from baseline (Visit 2) in the PaO2 area under the curve (AUC) for the time period 0 to 105 minutes obtained through arterial blood gases (ABGs) at the end of each treatment period. up to day 90
- Secondary Outcome Measures
Name Time Method Occurrence of adverse events up to day 90 Pulse rate and sitting blood pressure in conjunction with spirometry up to day 90 Maximum increase in alveolar-arterial oxygen gradient from baseline up to day 90 Change from baseline (Visit 2) in FEV1 prior to insertion of catheter and 15 minutes post removal of catheter up to day 90 Change from baseline (Visit 2) in FVC prior to insertion of catheter and 15 minutes post removal of catheter up to day 90 Maximum decline in PaO2 from baseline up to day 90 Rescue medication use up to day 90 COPD symptom score up to day 90
Trial Locations
- Locations (2)
Hunter Holmes McGuire Medical Center
🇺🇸Richmond, Virginia, United States
Hines Veterans Administration Hospital
🇺🇸Hines, Illinois, United States