Conditions: Asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 102
Healthy volunteers: no

Brief summary:
The primary objective of this trial is to evaluate the safety and efficacy of two doses of tiotropium inhalation solution delivered via the Respimat® inhaler once daily in the afternoon in patients (1 to 5 years old) with persistent asthma on top of inhaled corticosteroid (ICS) treatment.

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-bromide intervention 2: tiotropium-bromide intervention 3: placebo
Intervention descriptions: intervention 1: IMP intervention 2: IMP intervention 3: placebo matching tiotropium

Protocol document: