A Phase III, Randomised, Double Blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety Over 48 Weeks of Orally Inhaled Tiotropium Bromide (2.5 and 5 µg Once Daily ) Delivered by the Respimat® Inhaler in Adolescents (12 to 17 Years Old) With Moderate Persistent Asthma.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 398
- 试验地点
- 66
- 主要终点
- FEV1 peak0-3 Change From Baseline
研究概览
简要总结
The aim of the study is to evaluate efficacy and safety of a 48-week treatment with two doses of tiotropium bromide compared to placebo in adolescent patients with moderate persistent asthma. Efficacy and safety will be assessed by measuring lung function parameters and evaluating the effects on asthma exacerbations, on Quality of life, on health care resource utilisation an on the 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
- 12 Years 至 17 Years（Child）
- 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
placebo
once daily, delivered with Respimat inhaler
干预措施: placebo Respimat (Drug)
tiotropium low dose
once daily, delivered with Respimat inhaler
干预措施: tiotropium Respimat low dose (Drug)
tiotropium high dose
once daily, delivered with Respimat inhaler
干预措施: tiotropium Respimat high dose (Drug)
结局指标
主要结局
FEV1 peak0-3 Change From Baseline
时间窗: Baseline and 24 weeks
Change from baseline in peak Forced expiratory volume in 1 second within the first 3 hours post dosing (FEV1 peak0-3) measured at week 24. Note, the measured values presented are actually adjusted means.
次要结局
- Trough FEV1 Change From Baseline(Baseline and 24 weeks)
- FVC peak0-3 Change From Baseline(Baseline and 24 weeks)
- Trough FVC Change From Baseline(Baseline and 24 weeks)
- FEV1 AUC (0-3h) Change From Baseline(Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks)
- FVC AUC (0-3h) Change From Baseline(Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks)
- FEF25-75 Change From Baseline(Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks)
- Use of PRN Rescue Medication During the Daytime(Baseline and Week 24)
- Use of PRN Rescue Medication During the Night-time(Baseline and week 24)
- Use of PRN Rescue Medication During the Day(Baseline and week 24)
- Control of Asthma as Assessed by ACQ Total Score(Baseline and week 24)
- ACQ Total Score Responders(Week 24)
- Control of Asthma as Assessed by ACQ6(Baseline and week 24)
- ACQ6 Responders(Week 24)
- Time to First Severe Asthma Exacerbation During the 48 Week Treatment Period(48 weeks)
- Time to First Asthma Exacerbation During the 48 Week Treatment Period(Week 48)