At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 813 enrolled
Drug / intervention
tiotropium +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, 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 tiotropium, placebo, and 1 other intervention for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 813 participants across 77 sites in 10 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
CountriesBelgium, Canada, Czechia, Denmark, Finland, Germany, South Africa, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 2013
Enrollment StartNov 2013
Primary CompletionOct 2014
Study CompletionNov 2014
TodayJul 2026
First PostedOct 17, 2013
Enrollment StartNov 1, 2013
Primary CompletionOct 1, 2014
Study CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 12.7 years ago
Interventions
tiotropiumdrug
fixed dose combination
placebodrug
olodateroldrug
fixed dose combination
tiotropiumdrug
fixed dose combination
tiotropiumdrug
olodateroldrug
fixed dose combination