Conditions: Asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 465
Healthy volunteers: no

Brief summary:
The aim of this trial is to evaluate the efficacy and safety of 2.5 and 5 mcg tiotropium compared to placebo over 12 week treatment period. Tiotropium inhalation solution will be delivered via Respimat inhaler and will be examined on top of maintenance inhaled corticosteroid treatment in patients with mild persistent asthma. Efficacy and safety will be assessed by measuring the effects on lung functions, effects on lung exacerbations, effects on asthma control and numbers of adverse events.

Detailed description:

Arms:
arm 1: once daily delivered via Respimat inhaler arm 2: once daily delivered via Respimat inhaler arm 3: once daily delivered via Respimat inhaler

Interventions: intervention 1: placebo intervention 2: tiotropium 2.5 mcg intervention 3: tiotropium 5 mcg
Intervention descriptions: intervention 1: To evaluate efficacy and safety of 2.5 and 5 mcg tiotropium versus placebo delivered via Respimat inhaler intervention 2: To evaluate efficacy and safety of 2.5 and 5 mcg tiotropium versus placebo delivered via Respimat inhaler intervention 3: To evaluate efficacy and safety of 2.5 and 5 mcg tiotropium versus placebo delivered via Respimat inhaler

Protocol document: