EUCTR2008-001156-43-NL进行中（未招募）不适用
A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis. - Tiotropium in CF
Boehringer Ingelheim bv0 个研究点目标入组 596 人开始时间: 2008年9月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 596
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- male or female patients with a documented diagnosis of Cystic Fibrosis (CF) and/or
- •a genotype with two identifiable mutations consistent with CF accompanied by one
- •or more clinical features with the CF phenotype
- •- pre-bronchodilator FEV1 =25% of predicted values
- •- clinically stable as defined by no evidence of acute upper or lower respiratory tract
- •infection within 4 week of screening; no pulmonary exacerbation requiring use of
- •i.v./oral/inhaled antibiotics, or oral corticosteroids within 4 weeks of screening; pre-
- •bronchodilator FEV1 at Visit 2 within 10% of FEV1 at Visit 1
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- known hypersensitivity to study drug or its components
- •- participation in another study with an Investigational drug within one month or
- •six half lives (whichever is greater) preceding the screening visit.
- •- pregnancy or child-bearing potential and not using medically approved form of
- •contraception
- •- new chronic medication for CF within four weeks of screening.
- •- clinically significant disease (other than CF) medical condition that would
- •compromise safety
研究者
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