A Randomised, Double-blind, Parallel-group Study to Assess the Safety and Efficacy of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed-dose Combination (2.5µg / 5µg, 5µg / 5µg ) and Olodaterol (5 µg) Delivered by the RESPIMAT Inhaler 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
- 122
- 试验地点
- 24
- 主要终点
- Number (%) of Patients With Drug-related AEs
研究概览
简要总结
The primary objective of this study is to assess the safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC and olodaterol (delivered by the RESPIMAT Inhaler) in Japanese patients with Chronic Obstructive Pulmonary Disease (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 —（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 (high dose)
Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT
干预措施: Tiotropium + Olodaterol (Drug)
Tiotropium + Olodaterol (high dose)
Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT
干预措施: Respimat (Device)
Olodaterol
Olodaterol solution for inhalation - RESPIMAT
干预措施: Olodaterol (Drug)
Olodaterol
Olodaterol solution for inhalation - RESPIMAT
干预措施: Respimat (Device)
Tiotropium + Olodaterol (low dose)
Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT
干预措施: Tiotropium + Olodaterol (Drug)
Tiotropium + Olodaterol (low dose)
Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT
干预措施: Respimat (Device)
结局指标
主要结局
Number (%) of Patients With Drug-related AEs
时间窗: From first drug administration until 21 days after the last administration, upto 392 days
Number (%) of patients with drug-related Adverse Events (AEs).
次要结局
- FEV1 AUC0-3h Response(Baseline and 1 h, 10 min pre-dose and 30 min, 1 h, 2 h, 3 h post-dose after 52 weeks)
- Trough FEV1 Response(Baseline and 1 h, 10 min pre-dose after 52 weeks)