At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 401 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution (2.5 mcg and 5 mcg) Delivered Via Respimat® Inhaler Once Daily in the Evening Over 12 Weeks as add-on Controller Therapy on Top of Usual Care in Children (6 to 11 Years Old) With Severe Persistent Asthma
In Brief
A Phase 3 clinical trial evaluating Placebo, Tiotropium low dose mcg, and 1 other intervention for Asthma. Completed, enrolled 401 participants across 94 sites in 17 countries.
Detailed Summary
The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution (2.5 mcg and 5 mcg) delivered via Respimat® inhaler once daily in the evening over 12 weeks, compared to placebo, as add-on controller therapy on top of usual care in children (6 to 11 years old) with severe persistent asthma.
Study Details
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2012
First PostedJul 2012
Primary CompletionMay 2015
TodayJul 2026
First PostedJul 6, 2012
Enrollment StartJul 1, 2012
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 14.0 years ago
Interventions
Placebodrug
2 actuations once daily in the evening
Tiotropium low dose mcgdrug
2 actuations once daily in the evening
Tiotropium high dosedrug
2 actuations once daily in the evening