At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 32 enrolled
Drug / intervention
Tiotropium (high dose) + Olodaterol +1 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, Open-label, Parallel-group Trial to Assess Pharmacokinetics and Safety of Tiotropium + Olodaterol Fixed-dose Combination (2.5 µg/ 5 µg, 5 µg/ 5 µg) Delivered by the RESPIMAT Inhaler After 3 Weeks Once Daily Treatment in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
In Brief
A Phase 1 clinical trial evaluating Tiotropium (high dose) + Olodaterol and Tiotropium (low dose) + Olodaterol for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 32 participants across 1 site.
Detailed Summary
The primary objective of this study is to assess pharmacokinetics of tiotropium + olodaterol fixed-dose combination (2.5 µg/ 5 µg, 5 µg/ 5 µg) delivered by the RESPIMAT inhaler after 3 weeks once daily treatment in Japanese patients with COPD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2012
First PostedOct 2012
Primary CompletionMar 2013
TodayJul 2026
First PostedOct 11, 2012
Enrollment StartOct 1, 2012
Primary CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 13.7 years ago
Interventions
Tiotropium (high dose) + Olodateroldrug
Tiotropium + Olodaterol solution for inhalation
Tiotropium (low dose) + Olodateroldrug
Tiotropium + Olodaterol solution for inhalation