CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,624 enrolled
Drug / intervention
tiotropium + olodaterol +5 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/NCT01431274
NCT01431274Phase 3Completed

A Randomised, Double-blind, Parallel Group Study to Assess the Efficacy and Safety of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (2.5 µg / 5 µg; 5 µg / 5 µg) (Delivered by the Respimat® Inhaler) Compared With the Individual Components (2.5 µg and 5 µg Tiotropium, 5 µg Olodaterol) (Delivered by the Respimat® Inhaler) in Patients With Chronic Obstructive Pulmonary Disease (COPD). [TOnado TM 1]

Boehringer Ingelheim·interventional·Posted Sep 9, 2011·Updated Jul 16, 2015

In Brief

A Phase 3 clinical trial evaluating tiotropium + olodaterol, tiotropium, and 2 other interventions for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 2,624 participants across 239 sites in 25 countries.

Detailed Summary

The overall objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the RESPIMAT Inhaler) compared with the individual components ( tiotropium, olodaterol) (delivered by the RESPIMAT Inhaler) in patients with Chronic Obstructive Pulmonary Disease (COPD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Australia, Bulgaria, Canada, China, Czechia, Denmark, Estonia, Finland, France, Germany, Guatemala, Hungary, India, Italy, Japan, Mexico, Netherlands, New Zealand, Portugal, Russia, Slovenia, South Korea, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 9, 2011
Enrollment StartSep 1, 2011
Primary CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 14.8 years ago

Interventions

tiotropium + olodateroldrug

fixed dose combination

tiotropiumdrug

low dose

olodateroldrug

one dose only

tiotropiumdrug

high dose

tiotropium + olodateroldrug

fixed dose combination

Respimatdevice

Respimat inhaler