At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 404 enrolled
Drug / intervention
tiotropium+olodaterol (low dose) +5 moredrug
Likely dose
tiotropium+olodaterol (low dose) 2.5 µgfrom 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-controlled, Parallel Group Study to Determine the Effect of 12 Weeks Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (2.5/5 µg and 5/5 µg) Delivered by the Respimat® Inhaler, on Exercise Endurance Time During Constant Work Rate Cycle Ergometry in Patients With Chronic Obstructive Pulmonary Disease (COPD)[Torracto (TM)]
In Brief
A Phase 3 clinical trial evaluating Respimat inhaler, tiotropium+olodaterol (low dose), and 2 other interventions for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 404 participants across 60 sites in 10 countries.
Detailed Summary
The primary objective of this study is to compare the effects of orally inhaled tiotropium + olodaterol fixed dose combination (2.5/5 µg; 5/5 µg) with placebo on exercise tolerance after 12 weeks of treatment in patients with COPD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesArgentina, Canada, Finland, France, Germany, Hungary, Italy, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2012
First PostedFeb 2012
Primary CompletionSep 2013
TodayJul 2026
First PostedFeb 3, 2012
Enrollment StartFeb 1, 2012
Primary CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 14.4 years ago
Interventions
Respimat inhalerdevice
Respimat inhaler
tiotropium+olodaterol (low dose)drug
2.5 µg tiotropium + 5 µg olodaterol
tiotropium + olodaterol (high dose)drug
5 µg tiotropium + 5 µg olodaterol
Respimat inhalerdevice
Respimat inhaler
Respimat inhalerdevice
Respimat inhaler
placebo to tiotropium+olodateroldrug
comparator