Conditions: Asthma
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 101
Healthy volunteers: no

Brief summary:
The aim of this trial is to select an optimum dose may be selected based on bronchodilator efficacy, safety evaluations and pharmacokinetics of tiotropium bromide.

Detailed description:

Arms:
arm 1: patients inhale 2 puffs (low dose) once daily in the evening via Respimat inhaler arm 2: patients inhale 2 puffs (medium dose) once daily in the evening via Respimat inhaler arm 3: patients inhale 2 puffs (high dose) once daily in the evening via Respimat inhaler arm 4: patients inhale 2 puffs of placebo inhalation solution matching tiotropium once daily in the evening via Respimat inhaler

Interventions: intervention 1: Tiotropium bromide intervention 2: Tiotropium bromide intervention 3: Tiotropium bromide intervention 4: Tiotropium bromide
Intervention descriptions: intervention 1: inhalation solution administered via Respimat in 3 different doses intervention 2: inhalation solution administered via Respimat in 3 different doses intervention 3: inhalation solution administered via Respimat in 3 different doses intervention 4: inhalation solution administered via Respimat in 3 different doses

Protocol document: