Randomised, Double-blind, Placebo-controlled, 3-way Cross-over Study to Determine the Effect of Treatment of Orally Inhaled BI 1744 CL (5 µg [2 Actuations of 2.5 µg] and 10 µg [2 Actuations of 5 µg]) Delivered by the Respimat® Inhaler on Exercise Endurance Time During Constant Work Rate Cycle Ergometry in Patients With Chronic Obstructive Pulmonary Disease
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 151
- Locations
- 19
- Primary Endpoint
- Adjusted Mean Endurance Time After 6 Weeks
Study Overview
Brief Summary
To compare the effects of BI 1744 CL versus placebo on exercise tolerance after 6 weeks of treatment in patients with Chronic Obstructive Pulmonary Disease
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Olodaterol (BI 1744) Low
Low dose inhaled orally once daily from the Respimat inhaler
Intervention: Olodaterol (BI 1744) (Drug)
Olodaterol (BI 1744) Low
Low dose inhaled orally once daily from the Respimat inhaler
Intervention: Olodaterol (BI 1744) Placebo (Drug)
Olodaterol (BI 1744) High
High dose inhaled orally once daily from the Respimat inhaler
Intervention: Olodaterol (BI 1744) (Drug)
Placebo
Olodaterol (BI 1744) placebo inhaled once daily from the Respimat inhaler
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Adjusted Mean Endurance Time After 6 Weeks
Time Frame: 6 weeks
Primary endpoint was endurance time during constant work rate ergometry to symptom limitation at 75% of maximal work capacity after 6 weeks of treatment. Mixed effects model on log10 transformation data. Adjusted means are back transformed to report as geometric means. Standard errors (SEs) are calculated using the delta method.
Secondary Outcomes
- Adjusted Mean Inspiratory Capacity at Isotime After 6 Weeks(6 weeks)
- Adjusted Mean Inspiratory Capacity at End of Exercise After 6 Weeks(6 weeks)
- Adjusted Mean Borg Scale of Breathing Discomfort at Pre-exercise After 6 Weeks(6 weeks)
- Adjusted Mean Borg Scale of Breathing Discomfort at End of Exercise After 6 Weeks(6 weeks)
- Change From Baseline to Day 43 in Blood Pressure(Baseline and Week 6)
- Adjusted Mean Borg Scale of Breathing Discomfort at Isotime After 6 Weeks(6 weeks)
- Adjusted Mean Functional Residual Capacity 1 Hour Post-dose After 6 Weeks(6 weeks)
- Adjusted Mean Forced Vital Capacity, 1 Hour Post-dose After 6 Weeks(6 weeks)
- Adjusted Mean Peak Expiratory Flow Rate, 30 Minutes Pre-dose After 6 Weeks(6 weeks)
- Change From Baseline to Day 43 in Pulse Rate(Baseline and Week 6)
- Number of Patients With Notable Changes in Heart Rate(Baseline and Week 6)
- Adjusted Mean Inspiratory Capacity at Pre-exercise After 6 Weeks(6 weeks)
- Adjusted Mean Forced Expiratory Volume in 1 Second, 30 Minutes Pre-dose After 6 Weeks(6 weeks)
- Number of Patients With Notable Increase in QRS Intervals(Baseline and Week 6)
- Adjusted Mean Functional Residual Capacity 30 Minutes Pre-dose After 6 Weeks(6 weeks)
- Adjusted Mean Inspiratory Capacity 30 Minutes Pre-dose After 6 Weeks(6 weeks)
- Adjusted Mean Inspiratory Capacity 1 Hour Post-dose After 6 Weeks(6 weeks)
- Adjusted Mean Total Lung Capacity 1 Hour Post-dose After 6 Weeks(6 weeks)
- Adjusted Mean Peak Expiratory Flow Rate, 1 Hour Post-dose After 6 Weeks(6 weeks)
- Number of Patients With Notable Increase in PR Intervals(Baseline and Week 6)
- Adjusted Mean Total Lung Capacity 30 Minutes Pre-dose After 6 Weeks(6 weeks)
- Adjusted Mean Forced Expiratory Volume in 1 Second, 1 Hour Post-dose After 6 Weeks(6 weeks)
- Adjusted Mean Forced Vital Capacity, 30 Minutes Pre-dose After 6 Weeks(6 weeks)