A Phase III Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution Delivered Via Respimat® Inhaler (2.5 and 5 µg Once Daily) Compared With Placebo and Salmeterol HFA MDI (50 µg Twice Daily) Over 24 Weeks in Moderate Persistent Asthma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,032
- 试验地点
- 125
- 主要终点
- Peak FEV1 Within 3 Hours Post-dose Response
研究概览
简要总结
The aim of this trial is to evaluate the efficacy and safety of 2.5 and 5 mcg tiotropium over a 24-week treatment period as compared to placebo and salmeterol (50 mcg twice daily). Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined on top of maintenance treatment with inhaled corticosteroid controller medication in patients with moderate persistent asthma. Efficacy and safety will be assessed by measuring effects on lung function, effects on asthma exacerbations, effects on quality of life, effects on asthma control, effects on health care resource utilisation, and number of adverse events.
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
- 18 Years 至 75 Years（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 low dose
Once daily, delivered with Respimat® inhaler (+ inhalation of placebo HFA MDI twice daily)
干预措施: placebo (Drug)
tiotropium low dose
Once daily, delivered with Respimat® inhaler (+ inhalation of placebo HFA MDI twice daily)
干预措施: tiotropium Respimat® low dose (Drug)
tiotropium high dose
Once daily, delivered with Respimat® inhaler (+ inhalation of placebo HFA MDI twice daily)
干预措施: tiotropium Respimat® high dose (Drug)
tiotropium high dose
Once daily, delivered with Respimat® inhaler (+ inhalation of placebo HFA MDI twice daily)
干预措施: placebo (Drug)
50 mcg salmeterol
Twice daily, delivered with HFA MDI (+ inhalation of placebo Respimat® inhaler once daily)
干预措施: placebo (Drug)
50 mcg salmeterol
Twice daily, delivered with HFA MDI (+ inhalation of placebo Respimat® inhaler once daily)
干预措施: 50 mcg salmeterol HFA MDI (Drug)
placebo
Once daily, delivered with Respimat® inhaler + twice daily delivered with HFA MDI
干预措施: placebo (Drug)
结局指标
主要结局
Peak FEV1 Within 3 Hours Post-dose Response
时间窗: 24 weeks
Peak forced expiratory volume in one second (FEV1) response within 3 hours post-dose determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.
Trough FEV1 Response
时间窗: 24 weeks
Trough FEV1 response determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.
The Responder Rate as Assessed by the ACQ From the Two Twin Trials 205.418 (NCT01172808) and the Present 205.419 (NCT01172821)
时间窗: 24 weeks
The responder rate as assessed by the Asthma Control Questionnaire (ACQ) determined at the end of the 24-week treatment period (on combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821)). A patient was considered to be a responder if he or she was reported with an improvement (decrease) in the ACQ total score of at least 0.5 points.
次要结局
- Peak FVC Within 3 Hours Post-dose Response(24 weeks)
- Trough FVC Response(24 weeks)
- FEV1 Area Under Curve 0-3 Hours (AUC0-3h) Response(24 weeks)
- FVC Area Under Curve 0-3 Hours (AUC0-3h) Response(24 weeks)
- Trough PEF Response(24 weeks)
- Total Asthma Quality of Life Questionnaire (AQLQs)) Score(24 weeks)
- Total Asthma Control Questionnaire (ACQ) Score(24 weeks)
- The Responder Rate as Assessed by the ACQ(24 weeks)
- Mean Pre-dose Morning PEF (PEF a.m.) Based on the Weekly Mean Response at Week 24(Baseline and last 7 days before week 24 visit)
- Mean Pre-dose Evening PEF (PEF p.m.) Based on the Weekly Mean Response at Week 24(Baseline and last 7 days before week 24 visit)
- PEF Variability(Last 7 days before week 24 visit)
- Mean Pre-dose Morning FEV1 (FEV1 a.m.) Based on the Weekly Mean Response at Week 24(Baseline and last 7 days before week 24 visit)
- Mean Pre-dose Evening FEV1 (FEV1 p.m.) Based on the Weekly Mean Response at Week 24(Baseline and last 7 days before week 24 visit)
- Mean Number of Puffs of Rescue Medication During the Entire 24-h Day Based on the Weekly Mean Response at Week 24(Baseline and last 7 days before week 24 visit)
- Asthma Symptom-free Days Based on the Weekly Mean Response at Week 24(Baseline and last 7 days before week 24 visit)
- Time to First Severe Asthma Exacerbation From the Two Twin Trials 205.418 (NCT01172808) and the Present 205.419 (NCT01172821)(24 weeks)
- Time to First Asthma Exacerbation From the Two Twin Trials 205.418 (NCT01172808) and the Present 205.419 (NCT01172821)(24 weeks)