Conditions: Asthma
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 98
Healthy volunteers: no

Brief summary:
Determine the 24-hour FEV1-profile of tiotropium solution for inhalation after 4 weeks treatment periods of 5 mcg tiotropium administered once daily in the evening and 2.5 mcg tiotropium administered twice daily (morning and evening). In addition compare the 24 hours pharmacokinetic profile of 5 mcg tiotropium administered once daily and 2.5mcg tiotropium administered twice daily in pharmacokinetic sub-investigation.

Detailed description:

Arms:
arm 1: 2 puffs of daily dose (5 mcg) in the evening and 2 puffs of matching placebo in the morning via Respimat inhaler arm 2: 2 puffs of half daily dose (2.5 mcg) twice daily, in the evening and in the morning via Respimat inhaler

Interventions: intervention 1: Tiotropium 5 mcg qd intervention 2: Tiotropium 2.5 mcg bid
Intervention descriptions: intervention 1: 2 puffs (2.5 mcg each) in the evening 5 mcg in total and 2 puffs of matching placebo in the morning intervention 2: 2 puffs (1.25 mcg each) twice daily, in the evening and in the morning, 5 mcg in total

Protocol document: