A 4-week, Randomised, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Tiotropium + Olodaterol Fixed Dose Combination (5/5 µg) Delivered by the Respimat® Inhaler Versus the Free Combination of Tiotropium 5 µg and Olodaterol 5 µg Delivered by Separate Respimat® Inhalers in Patients With Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 221
- 试验地点
- 22
- 主要终点
- Trough Forced Expiratory Volume in 1 Second (FEV1) (in Liter) After 28 Days of Treatment
研究概览
简要总结
This is a 4-week, multicenter, randomized, double-blind, parallel group and active controlled study.
Patients will be randomized (1 to 1 ratio) to a 4-week double-blind treatment period of either FDC (fixed-dose combination) of tiotropium + olodaterol (5/5 µg) plus placebo or the free combination of tiotropium 5 µg and olodaterol 5 µg; all administered via the Respimat® inhaler. The purpose is to show non-inferiority between the FDC and the free combination of tiotropium and olodaterol 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 (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
FDC of tiotropium + olodaterol
Fixed Dose Combination of tiotropium + olodaterol
干预措施: FDC of tiotropium + olodaterol (Drug)
FDC of tiotropium + olodaterol
Fixed Dose Combination of tiotropium + olodaterol
干预措施: Placebo (Drug)
Free combination tiotropium + olodaterol
干预措施: Tiotropium (Drug)
Free combination tiotropium + olodaterol
干预措施: Olodaterol (Drug)
结局指标
主要结局
Trough Forced Expiratory Volume in 1 Second (FEV1) (in Liter) After 28 Days of Treatment
时间窗: Day 29
This outcome measure presents FEV1 after 28 days of treatment (measurement on Day 29). Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), and was measured at 24 hours (+/- 10 minutes) after trial medication administration at Visit 5. The FEV1 measurement at Visit 4, which was 24 hours after the last open-label run-in treatment intake and 15 minutes before the first double-blind study drug intake was the baseline measurement.
次要结局
- Trough Forced Vital Capacity (FVC) (in Liter) After 28 Days of Treatment(Day 29)
- Chronic Obstructive Pulmonary Disease (COPD) Assessment Test™ (CAT) Score on Day 28(Day 28)