Efficacy and Safety of 3 Doses of Tiotropium Compared to Placebo in Adolescents (12 to 17 Yrs) With Moderate Asthma
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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.