CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 285 enrolled
Drug / intervention
Tiotropium Respimat +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/NCT01340209
NCT01340209Phase 3Completed
CompareCT.gov

A Phase III Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Safety and Efficacy of Tiotropium Inhalation Solution Delivered Via Respimat Inhaler (2.5 and 5 µg Once Daily) Compared With Placebo Over 52 Weeks in Patients With Moderate to Severe Persistent Asthma

Boehringer Ingelheim·interventional·Posted Apr 22, 2011·Updated Jul 4, 2014

In Brief

A Phase 3 clinical trial evaluating Tiotropium Respimat and Placebo Respimat for Asthma. Completed, enrolled 285 participants across 55 sites.

Detailed Summary

The aim of this trial is to evaluate the safety and efficacy of 2.5 and 5 µg tiotropium over a 52-week treatment period as compared to placebo. Tiotropium inhalation solution delivered by the Respimat inhaler will be examined on top of maintenance treatment with inhaled corticosteroid controller medication in patients with moderate to severe persistent asthma. Efficacy and safety will be assessed by measuring effects on lung function, effects on asthma exacerbations, effects on asthma control, and number of adverse events.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesJapan
CollaboratorsPfizer

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 22, 2011
Enrollment StartApr 1, 2011
Primary CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 15.2 years ago

Interventions

Tiotropium Respimatdrug

Tiotropium high dose once daily delivered with Respimat inhaler

Placebo Respimatdrug

Tiotropium placebo once daily delivered with Respimat inhaler

Tiotropium Respimatdrug

Tiotropium low dose once daily delivered with Respimat inhaler