A Phase III Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution Delivered Via Respimat® Inhaler (5 mcg/Day) Over 48 Weeks as add-on Controller Therapy on Top of Usual Care in Patients With Severe Persistent Asthma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 459
- 试验地点
- 73
- 主要终点
- Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 24 Weeks.
研究概览
简要总结
The trial is a randomised, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of 5 µg tiotropium over a 48-week treatment period as compared to placebo. Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined as add-on controller therapy on top of usual care in patients with severe persistent asthma.
The primary objective of each trial is to evaluate the long term efficacy of tiotropium over placebo on top of usual care in patients with severe persistent asthma as determined by pulmonary function testing, effects on asthma exacerbations, effects on quality of life, on asthma control and health care resource utilisation. The secondary objective of each trial is to compare the long term safety of tiotropium with placebo in this patient population.
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
- 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 5mcg/day
patient to receive double-blind treatment with either 5mcg/day tiotropium inhalation solution or placebo inhalation solution
干预措施: tiotropium 5mcg/day (Drug)
placebo
patient to receive double-blind treatment with either 5mcg/day tiotropium inhalation solution or placebo inhalation solution
干预措施: placebo (Drug)
结局指标
主要结局
Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 24 Weeks.
时间窗: Baseline and 24 weeks
Peak FEV1 0-3h response was defined as the difference between the maximum FEV1 measured within the first 3 hours post dosing after a treatment period of 24 weeks and the FEV1 baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.
Time to First Severe Asthma Exacerbation During the 48-week Treatment of the Pooled Data From the Two Twin Trials 205.416 (NCT00772538) and the Present 205.417 (NCT00776984).
时间窗: 48 weeks
Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.
Trough FEV1 Response Determined After a Treatment Period of 24 Weeks.
时间窗: Baseline and 24 weeks
The trough FEV1 is defined as the pre-dose FEV1 measured 10 minutes before the last administration of randomised treatment. Trough FEV1 response was defined as the difference between the trough FEV1 measured after a treatment period of 24 weeks and the FEV1 baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.
次要结局
- Mean Pre-dose FEV1 a.m. Response (Diary Data) of Last-7-days-before-week 24-visit.(Baseline and last 7 days before week 24 visit)
- Mean Pre-dose FEV1-p.m.Response (Diary Data) of Last-7-days-before-week 24-visit.(Baseline and last 7 days before week 24 visit)
- Time to First Severe Asthma Exacerbation During the 48-week Treatment.(48 weeks)
- Time to First Hospitalisation for Asthma Exacerbation During the 48-week Treatment Period.(48 weeks)
- ACQ at the End of the 48-week Treatment Period.(48 weeks)
- Asthma Symptom Free Days Response During the Last-7-days-before-week-24-visit .(Baseline and last 7 days before week 24 visit)
- Number of Hospitalisations for Asthma Exacerbations Per Patient During the 48-week Treatment Period.(48 weeks)
- Trough FVC Response at the End of the 24-week Treatment Period.(Baseline and 24 weeks)
- FVC (AUC0-3h) Response at the End of the 24-week Treatment Period.(Baseline and 24 weeks)
- AUC0-3h FEV1 Response at the End of the 48-week Treatment Period.(Baseline and 48 weeks)
- Number of Asthma Exacerbations Per Patient During the 48-week Treatment Period.(48 weeks)
- Number of Patients With at Least One Asthma Exacerbation During the 48-week Treatment Period.(48 weeks)
- Number of Patients With at Least One Hospitalisation for Asthma Exacerbation During the 48-week Treatment Period.(48 weeks)
- AQLQ(S) Total Score at the End of the 48-week Treatment Period.(48 weeks)
- Asthma Control as Assessed by Asthma Control Questionnaire (ACQ) at the End of the 24-week Treatment Period.(24 weeks)
- FEV1 Area Under the Curve (AUC0-3h) Response at the End of the 24-week Treatment Period.(Baseline and 24 weeks)
- Peak FEV1 0-3h Response at the End of the 48-week Treatment Period.(Baseline and 48 weeks)
- Trough FEV1 Response at the End of the 48-week Treatment Period.(Baseline and 48 weeks)
- Mean PEF Variability Response (Absolute Difference Between Morning and Evening PEF Value Divided by Their Mean) of Last-7-days-before-week 24-visit.(Baseline and last 7 days before week 24 visit)
- Quality of Life as Assessed by Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) at the End of the 24-week Treatment Period.(24 weeks)
- Peak (Within 3 Hours Post-dosing) Forced Vital Capacity (FVC) Response at the End of the 24-week Treatment Period.(Baseline and 24 weeks)
- Peak FVC 0-3h Response at the End of the 48-week Treatment Period.(Baseline and 48 weeks)
- Trough FVC Response at the End of the 48-week Treatment Period.(Baseline and 48 weeks)
- FVC AUC0-3h Response at the End of the 48-week Treatment Period.(Baseline and 48 weeks)
- Mean Pre-dose Morning Peak Expiratory Flow (PEFa.m.) Response (Diary Data) of Last-7-days-before-week-24-visit .(Baseline and last 7 days before week 24 visit)
- Mean Pre-dose Evening Peak Expiratory Flow (PEFp.m.) Response (Diary Data) of Last-7-days-before-week 24-visit.(Baseline and last 7 days before week 24 visit)
- Number of Severe Asthma Exacerbations Per Patient During the 48-week Treatment Period.(48 weeks)
- Number of Patients With at Least One Severe Asthma Exacerbation During the 48-week Treatment Period.(48 weeks)
- Mean Pro Re Nata (as Needed, PRN) Rescue Medication Use Response During the Last-7-days-before-week-24-visit .(Baseline and last 7 days before week 24 visit)