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.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 19
- 主要终点
- Adjusted Mean Endurance Time After 6 Weeks
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Olodaterol (BI 1744) Low
Low dose inhaled orally once daily from the Respimat inhaler
干预措施: Olodaterol (BI 1744) (Drug)
Olodaterol (BI 1744) Low
Low dose inhaled orally once daily from the Respimat inhaler
干预措施: Olodaterol (BI1744) (Drug)
Olodaterol (BI 1744) Low
Low dose inhaled orally once daily from the Respimat inhaler
干预措施: Olodaterol (BI 1744) placebo (Drug)
Olodaterol (BI 1744) High
High dose inhaled orally once daily from the Respimat inhaler
干预措施: Olodaterol (BI 1744) (Drug)
Placebo
Olodaterol (BI 1744) placebo inhaled orally from the Respimat inhaler
干预措施: Placebo (Drug)
结局指标
主要结局
Adjusted Mean Endurance Time After 6 Weeks
时间窗: 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.
次要结局
- Adjusted Mean Total Lung Capacity 1 Hour Post-dose After 6 Weeks(6 weeks)
- Adjusted Mean Forced Expiratory Volume in 1 Second, 30 Minutes Pre-dose After 6 Weeks(6 weeks)
- Change From Baseline to Day 43 in Blood Pressure(Baseline and Week 6)
- Adjusted Mean Functional Residual Capacity 1 Hour Post-dose After 6 Weeks(6 weeks)
- Adjusted Mean Inspiratory Capacity 1 Hour Post-dose After 6 Weeks(6 weeks)
- Adjusted Mean Forced Expiratory Volume in 1 Second, 1 Hour Post-dose After 6 Weeks(6 weeks)
- Change From Baseline to Day 43 in Pulse Rate(Baseline and Week 6)
- Adjusted Mean Inspiratory Capacity at Pre-exercise After 6 Weeks(6 weeks)
- Adjusted Mean Functional Residual Capacity 30 Minutes Pre-dose After 6 Weeks(6 weeks)
- Adjusted Mean Total Lung Capacity 30 Minutes Pre-dose After 6 Weeks(6 weeks)
- Adjusted Mean Peak Expiratory Flow Rate, 30 Minutes Pre-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 QRS Intervals(Baseline and Week 6)
- 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 Forced Vital Capacity, 30 Minutes Pre-dose After 6 Weeks(6 weeks)
- Number of Patients With Notable Changes in Heart Rate(Baseline and Week 6)
- Adjusted Mean Borg Scale of Breathing Discomfort at Isotime After 6 Weeks(6 weeks)
- Adjusted Mean Borg Scale of Breathing Discomfort at End of Exercise After 6 Weeks(6 weeks)
- Adjusted Mean Inspiratory Capacity 30 Minutes Pre-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, 1 Hour Post-dose After 6 Weeks(6 weeks)