At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 101 enrolled
Drug / intervention
Tiotropium bromide +3 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 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 Children 6 to 11 Yrs Old With Moderate Persistent Asthma
In Brief
A Phase 2 clinical trial evaluating Tiotropium bromide for Asthma. Completed, enrolled 101 participants across 24 sites in 6 countries.
Detailed Summary
The aim of this trial is to select an optimum dose may be selected based on bronchodilator efficacy, safety evaluations and pharmacokinetics of tiotropium bromide.
Study Details
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 2011
Enrollment StartAug 2011
Primary CompletionSep 2012
TodayJul 2026
First PostedJun 28, 2011
Enrollment StartAug 1, 2011
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 15.0 years ago
Interventions
Tiotropium bromidedrug
inhalation solution administered via Respimat in 3 different doses
Tiotropium bromidedrug
inhalation solution administered via Respimat in 3 different doses
Tiotropium bromidedrug
inhalation solution administered via Respimat in 3 different doses
Tiotropium bromidedrug
inhalation solution administered via Respimat in 3 different doses