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 Adolescents (12 to 17 Yrs Old) With Moderate Persistent Asthma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 19
- 主要终点
- Forced Expiratory Volume (FEV1) Peak (0-3h) Response
研究概览
简要总结
The primary objective of this trial is to evaluate the efficacy and safety of tiotropium 1.25 mcg (2 actuations of 0.625 mcg), tiotropium 2.5 mcg (2 actuations of 1.25 mcg) and tiotropium 5 mcg (2 actuations of 2.5 mcg) once daily in the evening delivered by the Respimat inhaler in adolescents (12 to 17 yrs) with moderate persistent asthma, compared to placebo and on top of maintenance therapy with an inhaled corticosteroid controller medication. It is a randomised, double-blind, placebo-controlled Phase II trial with incomplete cross-over design. Patients need to be still symptomatic, i. e. not fully controlled with their maintenance treatment.
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
- 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
Treatment A
patients inhale 2 puffs (dose of 1.25 mcg) once daily in the evening via Respimat inhaler
干预措施: tiotropium bromide (Drug)
Treatment C
patients inhale 2 puffs (dose of 5 mcg) once daily in the evening via Respimat inhaler
干预措施: tiotropium bromide (Drug)
Placebo
patients inhale 2 puffs of placebo matching tiotropium once daily in the evening via Respimat inhaler
干预措施: Placebo (Drug)
Treatment B
patients inhale 2 puffs (dose of 2.5 mcg) 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)
- FEV1 Area Under the Curve From 0 to 3 h (AUC0-3h) Response(Baseline and 4 weeks)
- FEV1 Individual Measurements Response at Each Time-point(Baseline and 4 weeks (10 min pre-dose, 30 min, 1,2,3 hours post-dose))
- Forced Vital Capacity (FVC) Peak (0-3h) Response(Baseline and 4 weeks)
- FVC Trough Response(Baseline and 4 weeks)
- FVC Area Under the Curve From 0 to 3 h (AUC0-3h) Response(Baseline and 4 weeks)
- FVC Individual Measurements at Each Time-point(Baseline and 4 weeks (10 min pre-dose, 30 min, 1,2,3 hours post-dose))
- Forced Expiratory Flow (FEF) 25-75% Individual Measurements Response at Each Time Point(Baseline and 4 weeks (10 min pre-dose, 30 min, 1,2,3 hours post-dose))
- 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 Day(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))