A Randomised, Placebo-controlled, Double-blind, Single Dose, Cross-over Study to Evaluate the Efficacy and Safety of Orally Inhaled Tiotropium + Olodaterol as Both a Fixed Dose Combination and a Free Combination (Both Delivered by the Respimat® Inhaler) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 6
- 主要终点
- Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3hours) Response After Single-dose Administration
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy and safety of orally inhaled tiotropium and olodaterol as both a fixed dose combination and a free combination with respect to lung function and ECG parameters
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 —（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 FDC
patient will receive tiotropium and olodaterol in a fixed dose combination
干预措施: tiotropium (Drug)
Tiotropium/Olodaterol FDC
patient will receive tiotropium and olodaterol in a fixed dose combination
干预措施: olodaterol (Drug)
Tiotropium and Olodaterol FC
patient will receive tiotropium and olodaterol in a free combination
干预措施: olodaterol (Drug)
Tiotropium and Olodaterol FC
patient will receive tiotropium and olodaterol in a free combination
干预措施: tiotropium (Drug)
Placebo
patient will receive placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3hours) Response After Single-dose Administration
时间窗: 1 hour (h) and 10 min pre-dose and at 15 min, 30 min, 1 h, 2 h and 3 h post-dose
The response was defined as the change from patient baseline. Patient baseline was the average of the mean pre-dose values (period baseline) on each test day (Visit 2 (Day 1), Visit 3 (Day 22 (±7days)), and Visit 4 (Day 43±7days)). For patients who did not complete all periods, patient baseline was the average of the available period baselines. The means presented are the adjusted means.
次要结局
- Peak PR (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points(40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose)
- Mean QRS (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points(40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose)
- Mean (Heart Rate Corrected QT Interval (Using Fredericia Adjustment)) QTcF Interval Change From Patient Baseline Over All Post-dose Time Points(40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose)
- Peak QTcF Interval Change From Patient Baseline Over All Post-dose Time Points(40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose)
- Mean Heart Rate Change From Patient Baseline Over All Post-dose Time Points(40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose)
- Heart Rate Change From Patient Baseline at Individual Post-dose Time Points(40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose)
- Mean QT (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points(40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose)
- Peak Heart Rate Change From Patient Baseline Over All Post-dose Time Points(40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose)
- Peak RR Change From Patient Baseline Over All Post-dose Time Points(40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose)
- RR Change From Patient Baseline at Individual Post-dose Time Points(40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose)
- QT Change From Patient Baseline at Individual Post-dose Time Points(40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose)
- QRS Change From Patient Baseline at Individual Post-dose Time Points(40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose)
- Mean RR (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points(40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose)
- QTcB Change From Patient Baseline at Individual Post-dose Time Points(40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose)
- Mean PR (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points(40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose)
- Peak QRS (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points(40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose)
- Peak QT (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points(40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose)
- Mean QTcB (Heart Rate Corrected QT Interval (Using Bazett Adjustment)) Change From Patient Baseline Over All Post-dose Time Points(40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose)
- Peak QTcB (Heart Rate Corrected QT Interval (Using Bazett Adjustment)) Change From Patient Baseline Over All Post-dose Time Points(40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose)
- PR Change From Patient Baseline at Individual Post-dose Time Points(40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose)