Conditions: Cystic Fibrosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 464
Healthy volunteers: no

Brief summary:
To date, there have been no formal clinical studies completed using tiotropium in CF patients. While there is a large body of evidence demonstrating the efficacy and safety of tiotropium in patients with Chronic Obstructive Pulmonary Disease (COPD), relatively little is known about its efficacy and safety in patients with a diagnosis of cystic fibrosis. Therefore, Boehringer Ingelheim proposed to profile the long acting anticholinergic tiotropium and to generate adequate clinical data for use as a bronchodilator in paediatric and adult CF. The phase III trial (205.438) is a part of the approved Paediatric Investigation Plan (PIP) agreed for Spiriva® Respimat® in Cystic Fibrosis.

Detailed description:

Arms:
arm 1: 2 inhalations once daily delivered with Respimat® inhaler arm 2: 2 inhalations once daily delivered with Respimat® inhaler

Interventions: intervention 1: tiotropium Respimat® inhaler intervention 2: Placebo Respimat® inhaler
Intervention descriptions: intervention 1: to evaluate safety and efficacy tiotropium delivered with Respimat® inhaler compared to placebo. intervention 2: patient to receive placebo matching active drug once daily

Protocol document: