At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,539 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.
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 2]
In Brief
A Phase 3 clinical trial evaluating tiotropium + olodaterol, tiotropium, and 2 other interventions for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 2,539 participants across 240 sites in 24 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 COPD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesAustria, Belgium, Brazil, Canada, China, Colombia, Croatia, Germany, Hungary, India, Ireland, Japan, Norway, Romania, Russia, Serbia, Slovakia, South Africa, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2011
First PostedSep 2011
Primary CompletionNov 2013
TodayJul 2026
First PostedSep 9, 2011
Enrollment StartSep 1, 2011
Primary CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 14.8 years ago
Interventions
tiotropium + olodateroldrug
fixed dose combination
tiotropium + olodateroldrug
fixed dose combination
tiotropiumdrug
low dose or high dose
tiotropiumdrug
low dose or high dose
olodateroldrug
one dose only
Respimatdevice
Respimat inhaler