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 ug and 5 ug Once Daily) Compared to Placebo Over 12 Weeks in Mild Persistent Asthma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 465
- 试验地点
- 62
- 主要终点
- Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 12 Weeks.
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 compared to placebo over 12 week treatment period. Tiotropium inhalation solution will be delivered via Respimat inhaler and will be examined on top of maintenance inhaled corticosteroid treatment in patients with mild persistent asthma. Efficacy and safety will be assessed by measuring the effects on lung functions, effects on lung exacerbations, effects on asthma control and numbers 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 5 mcg
once daily delivered via Respimat inhaler
干预措施: tiotropium 5 mcg (Drug)
tiotropium 2.5 mcg
once daily delivered via Respimat inhaler
干预措施: tiotropium 2.5 mcg (Drug)
placebo
once daily delivered via Respimat inhaler
干预措施: placebo (Drug)
结局指标
主要结局
Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 12 Weeks.
时间窗: Baseline and 12 weeks
Peak FEV1 0-3h response was defined as the difference between the maximum FEV1 measured within the first 3 hours post dosing after a treatment period of 12 weeks and the FEV1 baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.
次要结局
- Peak (Within 3 Hours Post-dosing) Forced Vital Capacity (FVC) Response at the End of the 12-week Treatment Period.(Baseline and 12 weeks)
- FEV1 Area Under the Curve (AUC0-3h) Response at the End of the 12-week Treatment Period.(Baseline and 12 weeks)
- FVC (AUC0-3h) Response at the End of the 12-week Treatment Period.(Baseline and 12 weeks)
- Asthma Control Questionnaire (ACQ) Responder After 12 Weeks of Treatment(12 weeks)
- Time to First Severe Asthma Exacerbation During the 12-week Treatment.(12 weeks)
- Time to First Asthma Exacerbation During the 12-week Treatment.(12 weeks)
- Trough FEV1 Response Determined After a Treatment Period of 12 Weeks.(Baseline and 12 weeks)
- Use of Rescue Medication During 24h Period(Baseline and 12 weeks)
- Use of Rescue Medication During Daytime(Baseline and 12 weeks)
- Use of Rescue Medication During Nighttime(Baseline and 12 weeks)