Effect of Treatment BI 1744 CL (5 and 10 mcg) Versus Placebo on Exercise Endurance Time During Constant Work Rate Cycle Ergometry I
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Registration Number
- NCT01040130
- Lead Sponsor
- Boehringer Ingelheim
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 151
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Olodaterol (BI 1744) High Olodaterol (BI 1744) High dose inhaled orally once daily from the Respimat inhaler Placebo Placebo Olodaterol (BI 1744) placebo inhaled once daily from the Respimat inhaler Olodaterol (BI 1744) Low Olodaterol (BI 1744) Low dose inhaled orally once daily from the Respimat inhaler Olodaterol (BI 1744) Low Olodaterol (BI 1744) Placebo Low dose inhaled orally once daily from the Respimat inhaler
- Primary Outcome Measures
Name Time Method Adjusted Mean Endurance Time After 6 Weeks 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 Outcome Measures
Name Time Method Adjusted Mean Forced Expiratory Volume in 1 Second, 30 Minutes Pre-dose After 6 Weeks 6 weeks Adjusted Mean Functional Residual Capacity 30 Minutes Pre-dose After 6 Weeks 6 weeks Adjusted Mean Inspiratory Capacity at Pre-exercise After 6 Weeks 6 weeks Adjusted Mean Forced Expiratory Volume in 1 Second, 1 Hour Post-dose After 6 Weeks 6 weeks Adjusted Mean Inspiratory Capacity at Isotime After 6 Weeks 6 weeks Isotime is defined as the endurance time of the constant work rate exercise test of shortest duration from Baseline visit, and Week 6 of each of the three treatment periods.
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 Borg scale rates discomfort with breathing at rest, during exercise and at end-exercise on a scale from 0=Nothing at all to 10=Maximal discomfort.
Adjusted Mean Borg Scale of Breathing Discomfort at End of Exercise After 6 Weeks 6 weeks Borg scale rates discomfort with breathing at rest, during exercise and at end-exercise on a scale from 0=Nothing at all to 10=Maximal discomfort.
Adjusted Mean Borg Scale of Breathing Discomfort at Isotime After 6 Weeks 6 weeks Isotime is defined as the endurance time of the constant work rate exercise test of shortest duration from Baseline visit, and Week 6 of each of the three treatment periods.
Borg scale rates discomfort with breathing at rest, during exercise and at end-exercise on a scale from 0=Nothing at all to 10=Maximal discomfort.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 Change from Baseline to Day 43 in Pulse rate with spirometry. Baseline is defined as mean of pre-treatment values at a given time point.
Number of Patients With Notable Changes in Heart Rate Baseline and Week 6 Number of Patients with notable changes in heart rate (HR). Notable HR increase defined as \>=25% increase and on-treatment HR \> 100 bpm; Notable HR decrease defined as \>=25% decrease and on-treatment HR \< 50 bpm.
Change From Baseline to Day 43 in Blood Pressure Baseline and Week 6 Change from Baseline to Day 43 in Blood Pressure with spirometry. Baseline is defined as mean of pre-treatment values at a given time point.
Number of Patients With Notable Increase in QRS Intervals Baseline and Week 6 Number of Patients with notable increase in QRS intervals. Notable QRS interval increase defined as \>=10% increase and on-treatment QRS interval \> 110 ms.
Adjusted Mean Inspiratory Capacity 30 Minutes Pre-dose After 6 Weeks 6 weeks Measured using body plethysmography
Adjusted Mean Inspiratory Capacity 1 Hour Post-dose After 6 Weeks 6 weeks Measured using body plethysmography
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 Number of Patients with notable increase in PR intervals. Notable PR interval increase defined as \>=25% increase and on-treatment PR interval \> 200 ms.
Adjusted Mean Total Lung Capacity 30 Minutes Pre-dose After 6 Weeks 6 weeks Measured using body plethysmography
Adjusted Mean Forced Vital Capacity, 30 Minutes Pre-dose After 6 Weeks 6 weeks
Trial Locations
- Locations (19)
1222.37.6171 Boehringer Ingelheim Investigational Site
🇦🇺Daw Park, South Australia, Australia
1222.37.4371 Boehringer Ingelheim Investigational Site
🇦🇹Gänserndorf, Austria
1222.37.6172 Boehringer Ingelheim Investigational Site
🇦🇺Melbourne, Victoria, Australia
1222.37.1074 Boehringer Ingelheim Investigational Site
🇨🇦Montreal, Quebec, Canada
1222.37.6174 Boehringer Ingelheim Investigational Site
🇦🇺Clayton, Victoria, Australia
1222.37.6173 Boehringer Ingelheim Investigational Site
🇦🇺Heidelberg, Victoria, Australia
1222.37.33002 Boehringer Ingelheim Investigational Site
🇫🇷Montpellier, France
1222.37.4972 Boehringer Ingelheim Investigational Site
🇩🇪Halle, Germany
1222.37.4372 Boehringer Ingelheim Investigational Site
🇦🇹Neumarkt am Wallersee, Austria
1222.37.4971 Boehringer Ingelheim Investigational Site
🇩🇪Rüdersdorf, Germany
1222.37.33006 Boehringer Ingelheim Investigational Site
🇫🇷Paris, France
1222.37.1073 Boehringer Ingelheim Investigational Site
🇨🇦Ste-Foy, Quebec, Canada
1222.37.33005 Boehringer Ingelheim Investigational Site
🇫🇷Bethune Cedex, France
1222.37.1072 Boehringer Ingelheim Investigational Site
🇨🇦Hamilton, Ontario, Canada
1222.37.33003 Boehringer Ingelheim Investigational Site
🇫🇷Strasbourg, France
1222.37.33001 Boehringer Ingelheim Investigational Site
🇫🇷Nîmes, France
1222.37.4973 Boehringer Ingelheim Investigational Site
🇩🇪Magdeburg, Germany
1222.37.33004 Boehringer Ingelheim Investigational Site
🇫🇷Perpignan, France
1222.37.4970 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany