A Phase II Randomised, Double-blind, Placebo-controlled Incomplete Crossover Trial With 4-week Treatment Periods to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution (Doses of 1.25 µg, 2.5 µg and 5 µg) Delivered Via Respimat® Inhaler Once Daily in the Evening in Children 6 to 11 Yrs Old With Moderate Persistent Asthma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 24
- 主要终点
- Forced Expiratory Volume (FEV1) Peak (0-3h) Response
研究概览
简要总结
The aim of this trial is to select an optimum dose may be selected based on bronchodilator efficacy, safety evaluations and pharmacokinetics of tiotropium bromide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 11 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
Treatment A
patients inhale 2 puffs (low dose) once daily in the evening via Respimat inhaler
干预措施: Tiotropium bromide (Drug)
Treatment B
patients inhale 2 puffs (medium dose) once daily in the evening via Respimat inhaler
干预措施: Tiotropium bromide (Drug)
Treatment C
patients inhale 2 puffs (high dose) once daily in the evening via Respimat inhaler
干预措施: Tiotropium bromide (Drug)
Treatment D
patients inhale 2 puffs of placebo inhalation solution matching tiotropium once daily in the evening via Respimat inhaler
干预措施: Tiotropium bromide (Drug)
结局指标
主要结局
Forced Expiratory Volume (FEV1) Peak (0-3h) Response
时间窗: Baseline and 4 weeks
The FEV1 peak (0-3h) response is determined at the end of the 4 week treatment period. This is the difference between the maximum FEV1 measured within the first 3 hours post dosing and the FEV1 baseline measurement. Analysis adjusted for treatment, period, patient and baseline using a mixed model.
次要结局
- Trough FEV1 Response(Baseline and 4 weeks)
- Forced Vital Capacity (FVC) Peak (0-3h) Response(Baseline and 4 weeks)
- FVC Trough Response(Baseline and 4 weeks)
- FEV1 Area Under the Curve From 0 to 3 h (AUC0-3h) Response(Baseline and 4 weeks)
- FVC Area Under the Curve From 0 to 3 h (AUC0-3h) Response(Baseline and 4 weeks)
- Mean Morning Peak Expiratory Flow (PEF) Response(Baseline and 4 weeks)
- Mean Evening PEF Response(Baseline and 4 weeks)
- Change From Baseline in the Number of Puffs of Rescue Medication Per Period (24 h, Daytime and Night-time Use)(Baseline and 4 weeks)
- Control of Asthma as Assessed by Asthma Control Questionnaire (ACQ)(4 weeks)
- Change From Baseline in Mean Number of Nighttime Awakenings(Baseline and last week of treatment (week 4))