CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 102 enrolled
Drug / intervention
tiotropium-bromide +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.

Search/NCT01634113
NCT01634113Phase 2Completed
CompareCT.gov

A Phase II/III, Randomised, Double-blind, Placebo-controlled, Parallel Group Trial to Evaluate Safety and Efficacy of Tiotropium Inhalation Solution (2.5 µg and 5 µg) Administered Once Daily in the Afternoon Via Respimat® Inhaler for 12 Weeks in Patients 1 to 5 Years Old With Persistent Asthma

Boehringer Ingelheim·interventional·Posted Jul 6, 2012·Updated Jun 23, 2015

In Brief

A Phase 2 clinical trial evaluating tiotropium-bromide and placebo for Asthma. Completed, enrolled 102 participants across 33 sites in 11 countries.

Detailed Summary

The primary objective of this trial is to evaluate the safety and efficacy of two doses of tiotropium inhalation solution delivered via the Respimat® inhaler once daily in the afternoon in patients (1 to 5 years old) with persistent asthma on top of inhaled corticosteroid (ICS) treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesBelgium, Finland, Germany, Latvia, Lithuania, Malaysia, Netherlands, Philippines, South Korea, Ukraine, United States
CollaboratorsPfizer

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 6, 2012
Enrollment StartJul 1, 2012
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 14.0 years ago

Interventions

tiotropium-bromidedrug

IMP

tiotropium-bromidedrug

IMP

placebodrug

placebo matching tiotropium