A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Determine the Effect of 12 Weeks Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (2.5/5 µg and 5/5 µg) Delivered by the Respimat® Inhaler, on Exercise Endurance Time During Constant Work Rate Cycle Ergometry in Patients With Chronic Obstructive Pulmonary Disease (COPD)[Torracto (TM)]
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 404
- 试验地点
- 60
- 主要终点
- Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) After 12 Weeks
研究概览
简要总结
The primary objective of this study is to compare the effects of orally inhaled tiotropium + olodaterol fixed dose combination (2.5/5 µg; 5/5 µg) with placebo on exercise tolerance after 12 weeks of treatment in patients with COPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
tiotropium+olodaterol low dose
once daily 2 puffs, fixed dose combination (FDC) solution for inhalation Respimat
干预措施: Respimat inhaler (Device)
tiotropium+olodaterol low dose
once daily 2 puffs, fixed dose combination (FDC) solution for inhalation Respimat
干预措施: tiotropium+olodaterol (low dose) (Drug)
tiotropium+olodaterol high dose
once daily 2 puffs, FDC solution for inhalation Respimat
干预措施: tiotropium + olodaterol (high dose) (Drug)
tiotropium+olodaterol high dose
once daily 2 puffs, FDC solution for inhalation Respimat
干预措施: Respimat inhaler (Device)
placebo
once daily 2 puffs, solution for inhalation Respimat
干预措施: Respimat inhaler (Device)
placebo
once daily 2 puffs, solution for inhalation Respimat
干预措施: placebo to tiotropium+olodaterol (Drug)
结局指标
主要结局
Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) After 12 Weeks
时间窗: 12 weeks
Primary endpoint was endurance time during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity after 12 weeks of treatment. The endurance time in seconds was transformed using log10 scale to correct skewness in endurance time on original scale and then the MMRM model was fitted to the log10-transformed data and the least square means and SEs were obtained. To present the results in a way easier for interpretation, the least square mean from the MMRM fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate for the log10 of geometric mean and the corresponding SE was transformed using delta method to get the corresponding SEs of the geometric mean.
次要结局
- Adjusted Mean Inspiratory Capacity at Pre-exercise After 6 Weeks(6 weeks)
- Adjusted Mean Slope of the Intensity of Breathing Discomfort After Week 6(6 weeks)
- Adjusted Mean 1-hour, Post-dose Forced Expiratory Volume in One Second (FEV1) After 6 Weeks(6 weeks)
- Adjusted Mean Inspiratory Capacity at Pre-exercise After 12 Weeks(12 weeks)
- Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) on Day 1(1 day)
- Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) After 6 Weeks Treatment(6 weeks)
- Adjusted Mean Slope of the Intensity of Breathing Discomfort After Week 12(12 weeks)
- Adjusted Mean Endurance Time During Endurance Shuttle Walk Test (ESWT) After 12 Weeks(12 weeks)
- Adjusted Mean Inspiratory Capacity at Pre-exercise After 1 Day(1 day)
- Adjusted Mean Slope of the Intensity of Breathing Discomfort on Day 1(1 day)
- Adjusted Mean 1-hour, Post-dose Forced Expiratory Volume in One Second (FEV1) on Day 1(1 day)
- Adjusted Mean 1-hour, Post-dose Forced Expiratory Volume in One Second (FEV1) After 12 Weeks(12 weeks)