At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 403 enrolled
Drug / intervention
Tiotropium low dose QD +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 48 Weeks in Children (6 to 11 Years Old) With Moderate Persistent Asthma
In Brief
A Phase 3 clinical trial evaluating Tiotropium low dose QD, Tiotropium high dose QD, and 1 other intervention for Asthma. Completed, enrolled 403 participants across 79 sites in 16 countries.
Detailed Summary
The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5 mcg and 5 mcg once daily in the evening) over 48 weeks, compared to placebo, in children (6 to 11 years old) with moderate persistent asthma.
Study Details
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2012
First PostedJul 2012
Primary CompletionJun 2015
Study CompletionDec 2015
TodayJul 2026
First PostedJul 6, 2012
Enrollment StartJul 1, 2012
Primary CompletionJun 1, 2015
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 14.0 years ago
Interventions
Tiotropium low dose QDdrug
2 actuations once daily in the evening
Tiotropium high dose QDdrug
2 actuations once daily in the evening
Placebodrug
2 actuations once daily in the evening