High Dose Trial in COPD
Phase 2
Completed
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Registration Number
- NCT00128440
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The primary objective of this study was to compare the efficacy and safety of 200 μg and 400 μg of BEA 2180 BR to tiotropium 5 μg and placebo when each was delivered by the Respimat® Inhaler once daily for four weeks in patients with COPD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 78
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method forced expiratory volume in one second (FEV1) area under curve 3 to 6 hours (AUC0-6h) after four weeks of treatment. after 4 weeks Trough forced expiratory volume (FEV1) response baseline to 24 hours post drug administration
- Secondary Outcome Measures
Name Time Method FVC AUC0-6h after 0 and 4 weeks after 0 and 4 weeks Individual FEV1 and FVC measurements at each time point 4 weeks Trough FVC response after 4 weeks after 4 weeks Weekly mean number of occasions of rescue therapy used per day [as occasion requires (PRN) albuterol] 4 weeks Physician's Global Evaluation 4 weeks All adverse events 28 weeks FEV1 and FVC peak response after 0 and 4 weeks after 0 and 4 weeks Weekly mean pre-dose morning and evening PEFR 4 weeks COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest 4 weeks Pulse rate and blood pressure (seated) recorded in conjunction with spirometry for the first three hours following dosing 28 weeks 12-lead ECGs at baseline (-10 minutes) and at 25 minutes, 2 and 6 hours post dose on Day 1 and 29 of each treatment period (Visits 2-9) 28 weeks
Trial Locations
- Locations (1)
Boehringer Ingelheim Investigational Site
🇺🇸Tacoma, Washington, United States