Conditions: Cystic Fibrosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 510
Healthy volunteers: no

Brief summary:
This study evaluates the effects of 12-week treatment with two doses of tiotropium bromide (2.5 mcg q.d. and 5 mcg q.d.) compared to placebo administered via the Respimat device on lung function in patients with Cystic Fibrosis. The selection of the optimal dose will be based on bronchodilator efficacy, safety evaluations and pharmacokinetic evaluations

Detailed description:

Arms:
arm 1: patient to receive low dose tiotropium once daily arm 2: patient to receive high dose tiotropium once daily arm 3: patient to receive placebo once daily

Interventions: intervention 1: Placebo Respimat intervention 2: Tiotropium bromide 5 mcg intervention 3: tiotropium bromide-low dose-2.5mcg
Intervention descriptions: intervention 1: patient to receive placebo matching active drug once daily intervention 2: patient to recieve high dose tiotropium once daily intervention 3: patient to receive low dose tiotropium once daily

Protocol document: