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.

Conditions: Cystic fibrosis.
MedDRA version: 9.1Level: LLTClassification code 10011762Term: Cystic fibrosis

Registration Number: EUCTR2008-001156-43-PT

Lead Sponsor: Boehringer Ingelheim Pharmaceuticals, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 596

Inclusion Criteria

- 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

Exclusion Criteria

- 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: This study evaluates the effects of 12-week treatment with two doses of tiotropium bromide (2.5 µg q.d. and 5 µg q.d.) compared to placebo administered via the Respimat® device on lung function in patients with CF.<br>;Secondary Objective: Selection of the optimal dose will be based on bronchodilator efficacy, safety<br>evaluations and pharmacokinetic evaluations. ;Primary end point(s): Co-primary endpoints:<br>- change from baseline in forced expiratory volume in one second (FEV1) area under<br>the curve (AUC)0-4h at the end of Week 12 (Visit 6)<br>- change from baseline in trough FEV1 at the end of Week 12 (Visit 6)

Secondary Outcome Measures