A Randomised, Double-blinded, Active-controlled 2-way Cross Over Trial to Assess the Effects of 6 Weeks Treatment of Once Daily Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination Delivered by RESPIMAT Inhaler Compared With Tiotropium Delivered by RESPIMAT Inhaler on Lung Hyperinflation, Exercise Capacity and Physical Activity in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 43
- 主要终点
- Inspiratory Capacity at Rest Measured at 60 Minutes Post-dose
研究概览
简要总结
This is a multi-centre, randomised, double-blinded, active-controlled, 2-way cross over trial to assess the effects of once daily administration of orally inhaled tiotropium + olodaterol FDC or tiotropium (both delivered by the RESPIMAT Inhaler) on pulmonary function (lung hyperinflation), exercise capacity (6-minute walk distance) and physical activities after 6 weeks of treatment in Japanese 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 (Participant, Investigator)
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
inhalation two puffs from the RESPIMAT inhaler, once a day, in the morning
干预措施: tiotropium (Drug)
tiotropium + olodaterol
inhalation two puffs from the RESPIMAT inhaler, once a day, in the morning
干预措施: olodaterol (Drug)
tiotropium
inhalation two puffs from the RESPIMAT inhaler, once a day, in the morning
干预措施: tiotropium (Drug)
结局指标
主要结局
Inspiratory Capacity at Rest Measured at 60 Minutes Post-dose
时间窗: Day 43, 60 minutes post-dose after 6 weeks of each treatment
At day 43 inspiratory capacity at rest measured at 60 minutes post-dose, after 6 weeks of each treatment. Adjusted mean was entered instead of mean in statistical analysis.
次要结局
- 6-minute Walk Distance [Meter](Day 43, 60 minutes post-dose after 6 weeks of each treatment)
- Average Number of Step Per Day (Step/Day)(2 weeks prior to Week 6 per treatment)
- Average Daily Duration (Minutes) of ≥ 4 Metabolic Equivalents (METs)(2 weeks prior to Week 6 per treatment)
- Average Daily Duration (Minutes) of ≥ 3 Metabolic Equivalents (METs)(2 weeks prior to Week 6 per treatment)
- Average Daily Duration (Minutes) of ≥ 2 Metabolic Equivalents (METs)(2 weeks prior to Week 6 per treatment)
- Average Daily Active Strength (Metabolic Equivalents*Minutes) of ≥ 3 METs(2 weeks prior to Week 6 per treatment)
- 60 Minutes Post-dose Slow Vital Capacity (SVC) (in Litre)(Day 43, 60 minutes post-dose after 6 weeks of each treatment)
- 30 Minutes Post-dose Forced Expiratory Volume in One Second (FEV1) (in Litre)(Day 43, 30 minutes post-dose after 6 weeks of each treatment)
- 30 Minutes Post-dose Forced Vital Capacity (FVC) (in Litre)(Day 43, 30 minutes post-dose after 6 weeks of each treatment)