At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 398 enrolled
Drug / intervention
tiotropium Respimat low dose +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 Phase III, Randomised, Double Blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety Over 48 Weeks of Orally Inhaled Tiotropium Bromide (2.5 and 5 µg Once Daily ) Delivered by the Respimat® Inhaler in Adolescents (12 to 17 Years Old) With Moderate Persistent Asthma.
In Brief
A Phase 3 clinical trial evaluating tiotropium Respimat low dose, placebo Respimat, and 1 other intervention for Asthma. Completed, enrolled 398 participants across 66 sites in 12 countries.
Detailed Summary
The aim of the study is to evaluate efficacy and safety of a 48-week treatment with two doses of tiotropium bromide compared to placebo in adolescent patients with moderate persistent asthma. Efficacy and safety will be assessed by measuring lung function parameters and evaluating the effects on asthma exacerbations, on Quality of life, on health care resource utilisation an on the number of adverse events.
Study Details
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2010
First PostedDec 2010
Primary CompletionDec 2013
TodayJul 2026
First PostedDec 9, 2010
Enrollment StartDec 1, 2010
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 15.6 years ago
Interventions
tiotropium Respimat low dosedrug
IMP
placebo Respimatdrug
placebo representing comparator
tiotropium Respimat high dosedrug
IMP