CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 17,183 enrolled
Drug / intervention
tiotropium 18 mcg +2 moredrug
Likely dose
tiotropium 18 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/NCT01126437
NCT01126437Phase 3Completed
CompareCT.gov

A Randomized, Active-controlled, Double-blind, Double-dummy, Parallel Group Design, Multi-center Trial to Compare the Efficacy and Safety of 2.5 µg and 5 µg Tiotropium Inhalation Solution Delivered by the Respimat Inhaler With Tiotropium Inhalation Capsules 18 µg Delivered by the HandiHaler (TIOSPIR)

Boehringer Ingelheim·interventional·Posted May 19, 2010·Updated Jun 20, 2014

In Brief

A Phase 3 clinical trial evaluating tiotropium 18 mcg, tiotropium 1.25 mcg (2 actuations/day), and 1 other intervention for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 17,183 participants across 1,191 sites in 51 countries.

Detailed Summary

Direct comparison studies of the tiotropium HandiHaler® 18 µg and Respimat® 5 µg formulations have been limited to 4-week crossover studies. Therefore, prospective data from a trial of adequate size and duration is required to establish that compared to tiotropium HandiHaler®, tiotropium Respimat® will have (a) similar effects on safety and (b) similar or superior effects on exacerbations.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesArgentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Denmark, Finland, France, Georgia, Germany, Greece, Guatemala, Hungary, India, Ireland, Israel, Italy, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 19, 2010
Enrollment StartMay 1, 2010
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 16.1 years ago

Interventions

tiotropium 18 mcgdrug

HandiHaler

tiotropium 1.25 mcg (2 actuations/day)drug

soft mist inhaler 2 actuations=2 puffs/day

tiotropium 2.5 mcg (2 actuations/day)drug

soft mist inhaler (2 actuations=2 puffs/day)