At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Randomised, Double-blind, Placebo-controlled, Incomplete Crossover Trial With 4-week Treatment Periods to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution (Doses of 1.25 µg, 2.5 µg and 5 µg) Delivered Via Respimat® Inhaler Once Daily in the Evening in Adolescents (12 to 17 Yrs Old) With Moderate Persistent Asthma
In Brief
A Phase 2 clinical trial evaluating Tiotropium bromide, tiotropium bromide, and 1 other intervention for Asthma. Completed, enrolled 105 participants across 19 sites in 5 countries.
Detailed 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.
Study Details
Timeline
Interventions
inhalation solution, dose of 1.25 mcg (2 puffs of 0.625 mcg)
inhalation solution, dose of 2.5 mcg (2 puffs of 1.25 mcg)
inhalation solution, dose of 5 mcg (2 puffs of 2.5 mcg)
placebo inhalation solution