Conditions: Asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 398
Healthy volunteers: no

Brief summary:
The aim of the study is to evaluate efficacy and safety of a 48-week treatment with two doses of tiotropium bromide compared to placebo in adolescent patients with moderate persistent asthma. Efficacy and safety will be assessed by measuring lung function parameters and evaluating the effects on asthma exacerbations, on Quality of life, on health care resource utilisation an on the number of adverse events.

Detailed description:

Arms:
arm 1: once daily, delivered with Respimat inhaler arm 2: once daily, delivered with Respimat inhaler arm 3: once daily, delivered with Respimat inhaler

Interventions: intervention 1: tiotropium Respimat low dose intervention 2: placebo Respimat intervention 3: tiotropium Respimat high dose
Intervention descriptions: intervention 1: IMP intervention 2: placebo representing comparator intervention 3: IMP

Protocol document: