A Randomised, Double-blind, 5 Treatment Arms, 4-period, Incomplete Cross-over Study to Determine the Effect of 6 Weeks Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (FDC) (2.5 / 5 µg; and 5 / 5 µg) (Delivered by the Respimat® Inhaler) Compared With Tiotropium (5 µg), Olodaterol (5 µg ) and Placebo (Delivered by the Respimat® Inhaler) on Lung Hyperinflation and Exercise Endurance Time During Constant Work Rate Cycle Ergometry in Patients With Chronic Obstructive Pulmonary Disease (COPD) [MORACTO TM 1]
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 295
- 试验地点
- 44
- 主要终点
- Inspiratory Capacity at Rest Before Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap
研究概览
简要总结
The primary objective of this trial is to investigate the effect of 6 weeks treatment with tiotropium + olodaterol fixed dose combination inhalation solution on lung hyperinflation and exercise tolerance in patients with COPD
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
Tiotropium 5 mcg QD
patient will receive tiotropium 5 mcg once daily
干预措施: Respimat (Device)
Olodaterol 5 mcg QD
patient will receive olodaterol 5 mcg once daily
干预措施: Olodaterol (Drug)
Tiotropium + olodaterol High dose QD
patient will receive tiotropium 5 mcg + olodaterol 5 mcg in a fixed dose combination once daily
干预措施: Tiotropium + Olodaterol (Drug)
Tiotropium + olodaterol High dose QD
patient will receive tiotropium 5 mcg + olodaterol 5 mcg in a fixed dose combination once daily
干预措施: Respimat (Device)
Tiotropium + olodaterol Low dose QD
patient will receive tiotropium 2.5 mcg + olodaterol 5 mcg in a fixed dose combination once daily
干预措施: Tiotropium + Olodaterol (Drug)
Tiotropium + olodaterol Low dose QD
patient will receive tiotropium 2.5 mcg + olodaterol 5 mcg in a fixed dose combination once daily
干预措施: Respimat (Device)
Tiotropium 5 mcg QD
patient will receive tiotropium 5 mcg once daily
干预措施: Tiotropium (Drug)
Olodaterol 5 mcg QD
patient will receive olodaterol 5 mcg once daily
干预措施: Respimat (Device)
Placebo QD
干预措施: Placebo (Drug)
Placebo QD
干预措施: Respimat (Device)
结局指标
主要结局
Inspiratory Capacity at Rest Before Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap
时间窗: 6 weeks
Inspiratory capacity (IC) at rest before constant work rate cycle ergometry to symptom limitation at 75% maximal work capacity (Wcap). Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1. The presented means are adjusted means from the MMRM (Mixed Effects Model Repeated Measures) model.
Endurance Time During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap
时间窗: 6 weeks
Endurance time during constant work rate cycle ergometry (CWRCE) to symptom limitation at 75% work capacity (Wcap). Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1. The presented means are adjusted mean from the MMRM model.
次要结局
- Slope of the Intensity of Breathing Discomfort During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Work Capacity(6 weeks)
- Forced Expiratory Volume in 1 Second (One Hour Post-dose)(6 weeks)