Conditions: Asthma
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 94
Healthy volunteers: no

Brief summary:
Rationale for the current trial is to demonstrate 24 hour bronchodilator efficacy and safety of tiotropium 5 µg administered once daily (in the evening) which is regarded beneficial for the compliance and convenience of the patient in comparison to placebo. Further the rationale is to evaluate efficacy and safety of tiotropium 2.5 µg administered twice daily delivered by the Respimat® inhaler in comparison to placebo and tiotropium 5 µg administered once daily (in the evening) delivered by the Respimat® inhaler in patients with moderate persistent asthma.

Rationale for the pharmacokinetic subinvestigation is to evaluate the 24 hours exposure to tiotropium in patients with moderate persistent asthma when administered 5 µg tiotropium once daily (in the evening) or 2.5 µg tiotropium twice daily.

Detailed description:

Arms:
arm 1: two actuations delivered via Respimat® inhaler arm 2: two actuations delivered via Respimat® inhaler arm 3: N/A (two actuations of placebo) delivered via Respimat® inhaler

Interventions: intervention 1: Tiotropium 2.5 µg b.i.d intervention 2: Placebo intervention 3: Tiotropium 5 µg q.d.
Intervention descriptions: intervention 1: 2.5 µg (two actuations of 1.25 µg) delivered via Respimat® inhaler intervention 2: N/A (two actuations of placebo) delivered via Respimat® inhaler intervention 3: 5 µg (two actuations of 2.5 µg) delivered via Respimat® inhaler

Protocol document: