Conditions: Asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 401
Healthy volunteers: no

Brief summary:
The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution (2.5 mcg and 5 mcg) delivered via Respimat® inhaler once daily in the evening over 12 weeks, compared to placebo, as add-on controller therapy on top of usual care in children (6 to 11 years old) with severe persistent asthma.

Detailed description:

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

Interventions: intervention 1: Placebo intervention 2: Tiotropium low dose mcg intervention 3: Tiotropium high dose
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: