CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 465 enrolled
Drug / intervention
placebo +2 moredrug
Likely dose
tiotropium 2.5 mcgfrom 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.

Search/NCT01316380
NCT01316380Phase 3Completed
CompareCT.gov

A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution Delivered Via Respimat® Inhaler (2.5 ug and 5 ug Once Daily) Compared to Placebo Over 12 Weeks in Mild Persistent Asthma

Boehringer Ingelheim·interventional·Posted Mar 16, 2011·Updated Apr 15, 2015

In Brief

A Phase 3 clinical trial evaluating placebo, tiotropium 2.5 mcg, and 1 other intervention for Asthma. Completed, enrolled 465 participants across 62 sites in 12 countries.

Detailed Summary

The aim of this trial is to evaluate the efficacy and safety of 2.5 and 5 mcg tiotropium compared to placebo over 12 week treatment period. Tiotropium inhalation solution will be delivered via Respimat inhaler and will be examined on top of maintenance inhaled corticosteroid treatment in patients with mild persistent asthma. Efficacy and safety will be assessed by measuring the effects on lung functions, effects on lung exacerbations, effects on asthma control and numbers of adverse events.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesArgentina, Austria, Croatia, Estonia, Guatemala, Hungary, India, Italy, Latvia, Poland, Slovakia, South Korea
CollaboratorsPfizer

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 16, 2011
Enrollment StartMar 1, 2011
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 15.3 years ago

Interventions

placebodrug

To evaluate efficacy and safety of 2.5 and 5 mcg tiotropium versus placebo delivered via Respimat inhaler

tiotropium 2.5 mcgdrug

To evaluate efficacy and safety of 2.5 and 5 mcg tiotropium versus placebo delivered via Respimat inhaler

tiotropium 5 mcgdrug

To evaluate efficacy and safety of 2.5 and 5 mcg tiotropium versus placebo delivered via Respimat inhaler