Randomized, Double-blind, Double-dummy, Active-controlled, 4 Period Complete Cross-over Study to Compare the Effect on Lung Function of 6 Weeks Once Daily Treatment With Orally Inhaled Tiotropium+Olodaterol Fixed Dose Combination Delivered by the Respimat® Inhaler vs. 6 Weeks Twice Daily Treatment With Fluticasone Propionate+Salmeterol Fixed Dose Combination Delivered by the Accuhaler® in Patients With Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 229
- 试验地点
- 29
- 主要终点
- FEV1 AUC (0-12h) Change From Patient Baseline After 6 Weeks of Treatment
研究概览
简要总结
The objective of the trial is to compare the lung function profile of once daily treatment with tiotropium+olodaterol FDC [2.5/ 5µg and 5/ 5µg] delivered by the RESPIMAT with the lung function profile of twice daily treatment with fluticasone propionate+salmeterol FDC [250/50µg and 500/50µg] delivered by the Accuhaler® after 6 weeks of treatment.
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
T+O FDC dosage 1
Low dose
干预措施: placebo (Drug)
ICS/LABA FDC Dosage 1
Low dose
干预措施: placebo (Drug)
T+O FDC dosage 2
High dose
干预措施: placebo (Drug)
ICS/LABA FDC Dosage 2
High dose
干预措施: placebo (Drug)
T+O FDC dosage 1
Low dose
干预措施: olodaterol (Drug)
T+O FDC dosage 1
Low dose
干预措施: tiotropium (Drug)
ICS/LABA FDC Dosage 1
Low dose
干预措施: fluticasone propionate (Drug)
T+O FDC dosage 2
High dose
干预措施: tiotropium (Drug)
T+O FDC dosage 2
High dose
干预措施: olodaterol (Drug)
ICS/LABA FDC Dosage 1
Low dose
干预措施: salmeterol (Drug)
ICS/LABA FDC Dosage 2
High dose
干预措施: fluticasone propionate (Drug)
ICS/LABA FDC Dosage 2
High dose
干预措施: salmeterol (Drug)
结局指标
主要结局
FEV1 AUC (0-12h) Change From Patient Baseline After 6 Weeks of Treatment
时间窗: Baseline and 6 weeks.
Change from patient baseline in Forced Expiratory Volume in one second (FEV1) Area Under the FEV1-time Curve from 0 to 12hours post-dose (AUC 0-12h) \[L\] after 6 weeks of treatment. Measured values presented are actually adjusted means. The period baseline is defined as the pre-dose measurement taken at on the day 1 of each period. The patient baseline is defined as the mean of non-missing period baselines for each patient.
次要结局
- FEV1 AUC (0-24h) Change From Patient Baseline After 6 Weeks of Treatment(Baseline and 6 weeks.)
- Trough FEV1 Change From Patient Baseline After 6 Weeks of Treatment(Baseline and 6 weeks.)
- FEV1 AUC (12-24h) Change From Patient Baseline After 6 Weeks of Treatment(Baseline and 6 weeks.)
- FEV1 Peak (0-3h) Change From Patient Baseline After 6 Weeks of Treatment(Baseline and 6 weeks.)