A Phase II/III, Randomised, Double-blind, Placebo-controlled, Parallel Group Trial to Evaluate Safety and Efficacy of Tiotropium Inhalation Solution (2.5 µg and 5 µg) Administered Once Daily in the Afternoon Via Respimat® Inhaler for 12 Weeks in Patients 1 to 5 Years Old With Persistent Asthma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 33
- 主要终点
- FEV1 Peak (0-3h) Change From Baseline
研究概览
简要总结
The primary objective of this trial is to evaluate the safety and efficacy of two doses of tiotropium inhalation solution delivered via the Respimat® inhaler once daily in the afternoon in patients (1 to 5 years old) with persistent asthma on top of inhaled corticosteroid (ICS) treatment.
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
- 1 Year 至 5 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
tiotropium low dose
Once daily, delivered with Respimat® inhaler
干预措施: tiotropium-bromide (Drug)
tiotropium high dose
Once daily, delivered with Respimat® inhaler
干预措施: tiotropium-bromide (Drug)
placebo
Once daily, delivered with Respimat® inhaler
干预措施: placebo (Drug)
结局指标
主要结局
FEV1 Peak (0-3h) Change From Baseline
时间窗: 10 minutes before drug administration and 30 minutes, 1 hour (h), 2h and 3h after drug administration at baseline and week 12
Change from baseline in peak Forced expiratory volume in 1 second within the first 3 hours post dosing (FEV1 peak (0-3h)) measured at week 12
Weekly Mean Combined Daytime Asthma Symptom Score
时间窗: Baseline and 12 weeks
Change from baseline in the weekly mean combined daytime asthma symptom score as assessed by the Paediatric Asthma Caregivers Diary (PACD) in the last week of the 12 week treatment period. The PACD is a diary designed to evaluate daily asthma symptoms in children aged 2-5 years. The diary consists of three questions to be answered each morning, when the child wakes up, and seven questions to be answered each evening, right after the child goes to bed for the night. A week was defined as 7 days. The combined daytime score is the average of scores from questions 4 - 7 in the diary which are questions regarding severity of cough, wheezing, trouble breathing and interference with activities, scores for each question range from 0 (best) to 5 (worst). The week 12 weekly mean is the mean of the responses for each day averaged over the 7 days in week 12, so combined daytime asthma symptom scores also range from 0 (best) to 5 (worst). The measured values presented are adjusted means.
次要结局
- Individual FEV1 Measurements(Baseline and 12 weeks)
- Individual FVC Measurements(Baseline and 12 weeks)
- Weekly Mean Overnight Asthma Symptom Score Response(Baseline and 12 weeks)
- Weekly Mean Nighttime Awakenings Due to Asthma Symptoms(Baseline and 12 weeks)
- FEV1 AUC (0-3h) Change From Baseline(10 minutes before drug administration and 30 minutes, 1 hour (h), 2h and 3h after drug administration at baseline and week 12)
- Trough FVC Change From Baseline(Baseline and 12 weeks)
- FVC AUC (0-3h) Change From Baseline(10 minutes before drug administration and 30 minutes, 1 hour (h), 2h and 3h after drug administration at baseline and week 12)
- Weekly Percentage of Days Without Asthma Symptoms(12 weeks)
- Weekly Percentage of Days With Use of Salbutamol (Albuterol) Rescue Medication(12 weeks)
- Trough FEV1 Change From Baseline(Baseline and 12 weeks)
- FVC Peak (0-3h) Change From Baseline(10 minutes before drug administration and 30 minutes, 1 hour (h), 2h and 3h after drug administration at baseline and week 12)