Conditions: Asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1032
Healthy volunteers: no

Brief summary:
The aim of this trial is to evaluate the efficacy and safety of 2.5 and 5 mcg tiotropium over a 24-week treatment period as compared to placebo and salmeterol (50 mcg twice daily). 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 persistent asthma. Efficacy and safety will be assessed by measuring effects on lung function, effects on asthma exacerbations, effects on quality of life, effects on asthma control, effects on health care resource utilisation, and number of adverse events.

Detailed description:

Arms:
arm 1: Once daily, delivered with Respimat® inhaler (+ inhalation of placebo HFA MDI twice daily) arm 2: Once daily, delivered with Respimat® inhaler (+ inhalation of placebo HFA MDI twice daily) arm 3: Twice daily, delivered with HFA MDI (+ inhalation of placebo Respimat® inhaler once daily) arm 4: Once daily, delivered with Respimat® inhaler + twice daily delivered with HFA MDI

Interventions: intervention 1: placebo intervention 2: placebo intervention 3: placebo intervention 4: tiotropium Respimat® low dose intervention 5: placebo intervention 6: tiotropium Respimat® high dose intervention 7: 50 mcg salmeterol HFA MDI intervention 8: placebo
Intervention descriptions: intervention 1: Placebo that represents BI drug intervention 2: Placebo that represents comparator intervention 3: Placebo that represents comparator intervention 4: IMP intervention 5: Placebo that represents BI drug intervention 6: IMP intervention 7: Active comparator intervention 8: Placebo that represents comparator

Protocol document: