A Phase II, Randomised, Double- Blind, Placebo Controlled, Cross-over Efficacy and Safety Comparison of Tiotropium 5 µg Administered Once Daily (in the Evening) and Tiotropium 2.5 µg Administered Twice Daily Delivered by the Respimat® Inhaler for Four Weeks Versus Placebo in Patients With Moderate Persistent Asthma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 15
- 主要终点
- Forced Expiratory Volume in One Second (FEV1) Area Under the Curve 0-24 Hours (AUC0-24h) Response
研究概览
简要总结
Rationale for the current trial is to demonstrate 24 hour bronchodilator efficacy and safety of tiotropium 5 µg administered once daily (in the evening) which is regarded beneficial for the compliance and convenience of the patient in comparison to placebo. Further the rationale is to evaluate efficacy and safety of tiotropium 2.5 µg administered twice daily delivered by the Respimat® inhaler in comparison to placebo and tiotropium 5 µg administered once daily (in the evening) delivered by the Respimat® inhaler in patients with moderate persistent asthma.
Rationale for the pharmacokinetic subinvestigation is to evaluate the 24 hours exposure to tiotropium in patients with moderate persistent asthma when administered 5 µg tiotropium once daily (in the evening) or 2.5 µg tiotropium twice daily.
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
- 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 daily dose q.d.
two actuations delivered via Respimat® inhaler
干预措施: Tiotropium 5 µg q.d. (Drug)
Tiotropium half daily dose b.i.d.
two actuations delivered via Respimat® inhaler
干预措施: Tiotropium 2.5 µg b.i.d (Drug)
Placebo
N/A (two actuations of placebo) delivered via Respimat® inhaler
干预措施: Placebo (Drug)
结局指标
主要结局
Forced Expiratory Volume in One Second (FEV1) Area Under the Curve 0-24 Hours (AUC0-24h) Response
时间窗: 10 minutes (min) prior to first dose (baseline) and -10 min, 30 min, 60 min, 2 hours (h) , 3 h, 4 h , 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose at week 4
Mixed Model Repeated Measure (MMRM) results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measurements performed in relation to evening dosing. AUC0-24h calculated using the trapezoidal rule divided by the observation time (24 hours) to report in litres.
次要结局
- Mean Pre-dose Morning Peak Expiratory Flow (PEF a.m.) Response During the Last Week on Treatment(Baseline and during week 4 of each treatment period)
- Mean Pre-dose Evening Peak Expiratory Flow (PEF p.m.) Response During the Last Week on Treatment(Baseline and during week 4 of each treatment period)
- FEV1 Area Under the Curve 0-12 Hours (AUC0-12h) Response(10 min prior to first dose (baseline) and -10 min, 30 min, 60 min, 2 h, 3 h, 4 h and 11 h 50 min related to evening dose at week 4)
- FEV1 Area Under the Curve 12-24 Hours (AUC12-24h) Response(10 min prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose at week 4)
- Peak FEV1 Within 24 Hours Post-dose Response(Baseline and 4 weeks)
- Trough FEV1 Response(Baseline and 4 weeks)
- Trough Forced Vital Capacity (FVC) Response(Baseline and 4 weeks)
- FVC Area Under the Curve 0-12 Hours (AUC0-12h) Response(10 min prior to first dose (baseline) and -10 min, 30 min, 60 min, 2 h, 3 h, 4 h and 11 h 50 min related to evening dose at week 4)
- FVC Area Under the Curve 12-24 Hours (AUC12-24h) Response(10 min prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose at week 4)
- Peak FVC Within 24 Hours Post-dose Response(Baseline and 4 weeks)
- Individual FEV1 Over Time (at Each Timepoint at Visits) Response(Baseline and 4 weeks)
- Individual FVC Over Time (at Each Timepoint at Visits) Response(Baseline and 4 weeks)
- Individual Peak Expiratory Flow (PEF) Over Time (at Each Timepoint at Visits) Response(Baseline and 4 weeks)
- FVC Area Under the Curve 0-24 Hours (AUC0-24h) Response(10 min prior to first dose (baseline) and -10 min, 30 min, 60 min, 2 h, 3 h, 4 h , 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose at week 4)
- PEF Area Under the Curve 0-24 Hours (AUC0-24h) Response(10 min prior to first dose (baseline) and -10 min, 30 min, 60 min, 2 h, 3 h, 4 h , 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose at week 4)
- PEF Variability Response (Last Week on Treatment)(Baseline and during week 4)
- Mean Number of Puffs of Rescue Medication During the Whole Day (Last Week on Treatment, Response Values)(Baseline and during week 4)
- Mean Number of Puffs of Rescue Medication During Daytime (Last Week on Treatment, Response Values)(Baseline and during week 4)
- Mean Number of Puffs of Rescue Medication During Nighttime (Last Week on Treatment, Response Values)(Baseline and during week 4)
- Mean Number of Night Awakenings During the Last Week on Treatment (Score, Response Values)(Baseline and during week 4)