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-GB
• Lead Sponsor: Boehringer Ingelheim Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-14
• Last Update Posted: 10 July 2012

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 15% of FEV1 at Visit 1
- patients must be able to inhale medication in a reproducible manner from the Respimat inhaler and from a metered dose inhaler (MDI)
- patients taking a chronic medication must be willing to continue this therapy for the entire duration of the study
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 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified