A Randomised, Double Blind, Parallel Group Study to Assess the Efficacy and Safety of 12 Weeks of Once Daily, Orally Inhaled, Co-administration of Olodaterol 5µg (Delivered by the Respimat® Inhaler) and Tiotropium 18µg (Delivered by the HandiHaler®) Compared to Once Daily, Orally Inhaled, Co-administration of Placebo (Delivered by the Respimat® Inhaler) and Tiotropium 18µg (Delivered by the HandiHaler®) in Patients With Chronic Obstructive Pulmonary Disease (COPD)[ANHELTO TM 2]
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,137
- 试验地点
- 94
- 主要终点
- FEV1 AUC0-3h Response at 12 Weeks; Defined as Change From Baseline to Week 12
研究概览
简要总结
The overall objective of this study is to assess efficacy and safety of 12 weeks, once daily, orally inhaled co-administration of olodaterol 5 µg (delivered by the Respimat® Inhaler) and tiotropium (delivered by the Handihaler® as Spiriva Handihaler®), compared to tiotropium (Spiriva Handihaler®) monotherapy on lung function 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
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
Olodaterol andTiotropium
2 puffs Olodaterol from Respimat and one capsule Tiotropium by Handihaler once daily in am, co-administered
干预措施: Tiotropium (Drug)
Olodaterol andTiotropium
2 puffs Olodaterol from Respimat and one capsule Tiotropium by Handihaler once daily in am, co-administered
干预措施: Olodaterol (Drug)
Placebo and Tiotropium
2 puffs placebo inhalation solution from Respimat and one capsule Tiotropium by Handihaler once daily in am, co-administered
干预措施: Tiotropium (Drug)
Placebo and Tiotropium
2 puffs placebo inhalation solution from Respimat and one capsule Tiotropium by Handihaler once daily in am, co-administered
干预措施: Placebo matching Olodaterol (Drug)
结局指标
主要结局
FEV1 AUC0-3h Response at 12 Weeks; Defined as Change From Baseline to Week 12
时间窗: baseline and 12 weeks
FEV1 (Forced expiratory volume in 1 second) AUC0-3h (area under the curve) response at 12 weeks; defined as change from baseline to Week 12. AUC was standardized by dividing by time unit.
Trough FEV1 Response at 12 Weeks; Defined as Change From Baseline to Week 12
时间窗: baseline and 12 weeks
Trough FEV1 (Forced expiratory volume in 1 second) response at 12 weeks; defined as change from baseline to Week 12
次要结局
- Trough FVC Response at 12 Weeks; Defined as Change From Baseline(baseline and 12 weeks)
- Rescue Medication Usage - Percentage of Rescue Free Days(over 12 weeks)
- Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime)(over 12 weeks)
- Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime)(over 12 weeks)
- Saint George Respiratory Questionnaire - (Total Score) Based on Combined 1222.51 and 1222.52 Data(12 weeks)
- Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily)(over 12 weeks)
- Peak FEV1 Response at 12 Weeks - Defined as Change From Baseline(baseline and 12 weeks)
- FVC AUC0-3h Response at 12 Weeks; Defined as Change From Baseline(baseline and 12 Weeks)
- Peak FVC Response at 12 Weeks; Defined as Change From Baseline(baseline and 12 weeks)