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.

Boehringer Ingelheim Pharmaceuticals, Inc.0 个研究点目标入组 596 人开始时间: 2009年5月5日最近更新: 2012年7月10日

试验速览

暂无简介。

•- 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

•- known hypersensitivity to study drug or its components
•- participation in another study with an Investigational drug within
•- 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

发起方