A Phase III Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Safety and Efficacy of Tiotropium Inhalation Solution Delivered Via Respimat Inhaler (2.5 and 5 µg Once Daily) Compared With Placebo Over 52 Weeks in Patients With Moderate to Severe Persistent Asthma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 285
- 试验地点
- 55
- 主要终点
- Number of Patients With Drug-related Adverse Events
研究概览
简要总结
The aim of this trial is to evaluate the safety and efficacy of 2.5 and 5 µg tiotropium over a 52-week treatment period as compared to placebo. 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 to severe persistent asthma. Efficacy and safety will be assessed by measuring effects on lung function, effects on asthma exacerbations, effects on asthma control, 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 Respimat (low dose)
Tiotropium low dose once daily delivered with Respimat inhaler
干预措施: Tiotropium Respimat (Drug)
Tiotropium Respimat (high dose)
Tiotropium high dose once daily delivered with Respimat inhaler
干预措施: Tiotropium Respimat (Drug)
Placebo Respimat
Tiotropium placebo once daily delivered with Respimat inhaler
干预措施: Placebo Respimat (Drug)
结局指标
主要结局
Number of Patients With Drug-related Adverse Events
时间窗: after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409
The primary endpoint is the number of patients with drug-related adverse events
次要结局
- Weekly Mean Number of Puffs of Rescue Medication During the Whole Day (Response)(baseline and week 52)
- Trough FEV1 Response(baseline and week 52)
- Trough PEF Response(baseline and week 52)
- Trough FVC Response(baseline and week 52)
- Weekly Mean PEFpm Response(baseline and week 52)
- Weekly Mean Score of Asthma Symptoms During the Day (Response)(baseline and week 52)
- Weekly Mean Score of Asthma Symptoms in the Morning (Response)(baseline and week 52)
- Weekly Mean PEFam Response(baseline and week 52)
- Weekly Mean PEF Variability Response(baseline and week 52)