At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 7,903 enrolled
Drug / intervention
olodaterol +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.
A Randomised, Double-blind, Active-controlled Parallel Group Study to Evaluate the Effect of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination Compared With Tiotropium on Chronic Obstructive Pulmonary Disease (COPD) Exacerbation in Patients With Severe to Very Severe COPD. [DYNAGITO]
In Brief
A Phase 3 clinical trial evaluating olodaterol and tiotropium for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 7,903 participants across 818 sites in 51 countries.
Detailed Summary
The overall objective is to assess the effect of once daily tiotropium + olodaterol fixed dose combination compared to 5 µg tiotropium (both delivered with the Respimat® inhaler) on moderate to severe COPD exacerbation in patients with severe to very severe COPD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesArgentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States, Vietnam
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 2014
Enrollment StartJan 2015
Primary CompletionMar 2017
Study CompletionMar 2017
TodayJul 2026
First PostedNov 20, 2014
Enrollment StartJan 13, 2015
Primary CompletionMar 8, 2017
Study CompletionMar 29, 2017
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 11.6 years ago
Interventions
olodateroldrug
fixed dose combination
tiotropiumdrug
fixed dose combination
tiotropiumdrug