Conditions: Asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 285
Healthy volunteers: no

Brief summary:
The aim of this trial is to evaluate the safety and efficacy of 2.5 and 5 µg tiotropium over a 52-week treatment period as compared to placebo. Tiotropium inhalation solution delivered by the Respimat inhaler will be examined on top of maintenance treatment with inhaled corticosteroid controller medication in patients with moderate to severe persistent asthma. Efficacy and safety will be assessed by measuring effects on lung function, effects on asthma exacerbations, effects on asthma control, and number of adverse events.

Detailed description:

Arms:
arm 1: Tiotropium low dose once daily delivered with Respimat inhaler arm 2: Tiotropium high dose once daily delivered with Respimat inhaler arm 3: Tiotropium placebo once daily delivered with Respimat inhaler

Interventions: intervention 1: Tiotropium Respimat intervention 2: Placebo Respimat intervention 3: Tiotropium Respimat
Intervention descriptions: intervention 1: Tiotropium high dose once daily delivered with Respimat inhaler intervention 2: Tiotropium placebo once daily delivered with Respimat inhaler intervention 3: Tiotropium low dose once daily delivered with Respimat inhaler

Protocol document: