At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 122 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 Safety and Efficacy of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed-dose Combination (2.5µg / 5µg, 5µg / 5µg ) and Olodaterol (5 µg) Delivered by the RESPIMAT Inhaler in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
In Brief
A Phase 3 clinical trial evaluating Tiotropium + Olodaterol, Respimat, and 1 other intervention for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 122 participants across 24 sites.
Detailed Summary
The primary objective of this study is to assess the safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC and olodaterol (delivered by the RESPIMAT Inhaler) in Japanese patients with Chronic Obstructive Pulmonary Disease (COPD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2012
First PostedFeb 2012
Primary CompletionSep 2013
TodayJul 2026
First PostedFeb 22, 2012
Enrollment StartFeb 1, 2012
Primary CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 14.4 years ago
Interventions
Tiotropium + Olodateroldrug
Tiotropium and Olodaterol FDC once daily inhalation
Respimatdevice
Respimat inhaler
Tiotropium + Olodateroldrug
Tiotropium and Olodaterol FDC once daily inhalation
Olodateroldrug
Olodaterol once daily inhalation
Respimatdevice
Respimat inhaler
Respimatdevice
Respimat inhaler