Cystic fibrosis. MedDRA version: 9.1 Level: LLT Classification code 10011762 Term: Cystic fibrosis
Conditions
Interventions
Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation
Pharmaceutical Form: Inhalation vapour, solution
Other descriptive name: TIOTROPIUM
Concentration unit: µg microgram(s)
Concentratio
Sponsors
Boehringer Ingelheim France
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;Secondary Objective: Selection of the optimal dose will be based on bronchodilator efficacy, safety evaluations and pharmacokinetic evaluations. ;Primary end point(s): Co-primary endpoints: - change from baseline in forced expiratory volume in one second (FEV1) area under the curve (AUC)0-4h at the end of Week 12 (Visit 6) - change from baseline in trough FEV1 at the end of Week 12 (Visit 6) | — |
Countries
Belgium, France, Germany, Italy, Netherlands, Portugal, United Kingdom
Outcome results
None listed