A Randomized, Double-blind, Placebo-controlled Parallel Group Study to Investigate the Safety and Efficacy of Two Doses of Tiotropium Bromide (2.5 mcg and 5 mcg) Administered Once Daily Via the Respimat Device for 12 Weeks in Patients With Cystic Fibrosis.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 510
- 试验地点
- 107
- 主要终点
- Percent Predicted FEV1 AUC0-4 Response at the End of Week 12
研究概览
简要总结
This study evaluates the effects of 12-week treatment with two doses of tiotropium bromide (2.5 mcg q.d. and 5 mcg q.d.) compared to placebo administered via the Respimat device on lung function in patients with Cystic Fibrosis. The selection of the optimal dose will be based on bronchodilator efficacy, safety evaluations and pharmacokinetic evaluations
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
- 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 Respimat 2.5 mcg
patient to receive low dose tiotropium once daily
干预措施: tiotropium bromide-low dose-2.5mcg (Drug)
Tiotropium Respimat 5 mcg
patient to receive high dose tiotropium once daily
干预措施: Tiotropium bromide 5 mcg (Drug)
Placebo Respimat
patient to receive placebo once daily
干预措施: Placebo Respimat (Drug)
结局指标
主要结局
Percent Predicted FEV1 AUC0-4 Response at the End of Week 12
时间窗: Baseline, Week 12
Outcome measure description: Change from baseline in percent predicted Forced Expiratory Volume in one second (FEV1) Area Under the Curve from 0 to 4 hours (AUC0-4). Calculated as percent predicted at week 12 minus percent predicted at baseline.
Percent Predicted FEV1 Trough Response at the End of Week 12
时间窗: Baseline, Week 12
Outcome measure description: Change from baseline in percent predicted trough Forced Expiratory Volume in one second. Calculated as percent predicted at week 12 minus percent predicted at baseline.
次要结局
- Percent Predicted FVC AUC0-4 Response at the End of Week 12(Baseline, Week 12)
- Percent Predicted FVC Trough Response at the End of Week 12(Baseline, Week 12)
- Pre-bronchodilator FEF25-75 Percent Predicted at the End of Week 12(Baseline, Week 12)
- Change From Baseline in Residual Volume/Total Lung Capacity (RV/TLC) at the End of Week 12(Baseline, Week 12)
- Respiratory and Systemic Symptoms Questionnaire (RSSQ)(12 weeks)
- Change From Baseline in CFQ Scores - Adult Group(12 weeks)
- Change From Baseline in CFQ Scores - Adolescents Group(12 weeks)
- Change From Baseline in CFQ Scores - Parent Questionnaire(12 weeks)
- Amount of Tiotropium Eliminated in Urine From 0 to 4 Hours at Steady State (Ae0-4,ss)(pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose)
- Maximum Measured Concentration at Steady State (Cmax,ss)(pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose)
- Time From Dosing to the Maximum Concentration (Tmax,ss)(pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose)
- Clinical Relevant Abnormalities for Vital Signs and Laboratory Evaluation(From first drug administration until 30 days after last drug administration (up to 121 days))