Conditions: Asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 403
Healthy volunteers: no

Brief summary:
The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5 mcg and 5 mcg once daily in the evening) over 48 weeks, compared to placebo, in children (6 to 11 years old) with moderate persistent asthma.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: Tiotropium low dose QD intervention 2: Tiotropium high dose QD intervention 3: Placebo
Intervention descriptions: intervention 1: 2 actuations once daily in the evening intervention 2: 2 actuations once daily in the evening intervention 3: 2 actuations once daily in the evening

Protocol document: