At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 809 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, Placebo- and Active-controlled Parallel Group Study to Assess the Efficacy of 12 Weeks of Once Daily Treatment of Two Doses of Orally Inhaled Tiotropium+ Olodaterol Fixed Dose Combination (Delivered by the Respimat Inhaler) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
In Brief
A Phase 3 clinical trial evaluating olodaterol, tiotropium, and 1 other intervention for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 809 participants across 78 sites in 11 countries.
Detailed Summary
The objective of this study is to assess the efficacy and safety of 12 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the Respimat inhaler) compared with tiotropium and placebo in patients with COPD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesAustralia, Austria, Canada, Germany, Greece, New Zealand, Norway, Slovakia, South Africa, Sweden, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartNov 2013
First PostedDec 2013
Primary CompletionOct 2014
Study CompletionNov 2014
TodayJul 2026
First PostedDec 10, 2013
Enrollment StartNov 1, 2013
Primary CompletionOct 1, 2014
Study CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 12.6 years ago
Interventions
olodateroldrug
fixed dose combination
tiotropiumdrug
fixed dose combination
placebodrug