Conditions: Asthma
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 105
Healthy volunteers: no

Brief summary:
The primary objective of this trial is to evaluate the efficacy and safety of tiotropium 1.25 mcg (2 actuations of 0.625 mcg), tiotropium 2.5 mcg (2 actuations of 1.25 mcg) and tiotropium 5 mcg (2 actuations of 2.5 mcg) once daily in the evening delivered by the Respimat inhaler in adolescents (12 to 17 yrs) with moderate persistent asthma, compared to placebo and on top of maintenance therapy with an inhaled corticosteroid controller medication. It is a randomised, double-blind, placebo-controlled Phase II trial with incomplete cross-over design. Patients need to be still symptomatic, i. e. not fully controlled with their maintenance treatment.

Detailed description:

Arms:
arm 1: patients inhale 2 puffs (dose of 1.25 mcg) once daily in the evening via Respimat inhaler arm 2: patients inhale 2 puffs (dose of 5 mcg) once daily in the evening via Respimat inhaler arm 3: patients inhale 2 puffs of placebo matching tiotropium once daily in the evening via Respimat inhaler arm 4: patients inhale 2 puffs (dose of 2.5 mcg) once daily in the evening via Respimat inhaler

Interventions: intervention 1: Tiotropium bromide intervention 2: tiotropium bromide intervention 3: tiotropium bromide intervention 4: Placebo
Intervention descriptions: intervention 1: inhalation solution, dose of 1.25 mcg (2 puffs of 0.625 mcg) intervention 2: inhalation solution, dose of 2.5 mcg (2 puffs of 1.25 mcg) intervention 3: inhalation solution, dose of 5 mcg (2 puffs of 2.5 mcg) intervention 4: placebo inhalation solution

Protocol document: