At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 12 enrolled
Drug / intervention
Tiotropium +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.
An Open-label Trial to Assess Pharmacokinetics and Safety of Tiotropium + Olodaterol Fixed-dose Combination (5 µg/ 5 µg) Delivered by the RESPIMAT Inhaler After Single and Multiple Dose Treatment in Chinese Patients With Chronic Obstructive Pulmonary Disease (COPD)
In Brief
A Phase 1 clinical trial evaluating Tiotropium and Olodaterol for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 12 participants across 1 site.
Detailed Summary
The primary objective of this study is to assess the pharmacokinetics of tiotropium + olodaterol fixed-dose combination (FDC) (5 μg/ 5 μg) delivered by the RESPIMAT inhaler after single dose and at steady state in Chinese patients with COPD. The secondary objective is to assess the safety of tiotropium + olodaterol FDC (5 μg/ 5 μg) delivered by the RESPIMAT inhaler after 3 weeks once daily treatment in Chinese patients with COPD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesChina
Collaborators--
Timeline
Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 2016
Enrollment StartFeb 2017
Primary CompletionJun 2017
TodayJul 2026
First PostedNov 21, 2016
Enrollment StartFeb 24, 2017
Primary CompletionJun 15, 2017
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 9.6 years ago
Interventions
Tiotropiumdrug
Fixed dose combination
Olodateroldrug
Fixed dose combination