At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 295 enrolled
Drug / intervention
Placebo +5 moredrug
Likely dose
Tiotropium 5 mcgfrom 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, 5 Treatment Arms, 4-period, Incomplete Cross-over Study to Determine the Effect of 6 Weeks Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (FDC) (2.5 / 5 µg; and 5 / 5 µg) (Delivered by the Respimat® Inhaler) Compared With Tiotropium (5 µg), Olodaterol (5 µg ) and Placebo (Delivered by the Respimat® Inhaler) on Lung Hyperinflation and Exercise Endurance Time During Constant Work Rate Cycle Ergometry in Patients With Chronic Obstructive Pulmonary Disease (COPD) [MORACTO TM 1]
In Brief
A Phase 3 clinical trial evaluating Placebo, Tiotropium, and 4 other interventions for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 295 participants across 44 sites in 10 countries.
Detailed Summary
The primary objective of this trial is to investigate the effect of 6 weeks treatment with tiotropium + olodaterol fixed dose combination inhalation solution on lung hyperinflation and exercise tolerance in patients with COPD
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesArgentina, Australia, Austria, Belgium, Canada, Chile, Germany, Italy, New Zealand, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2012
Enrollment StartMar 2012
Primary CompletionNov 2013
TodayJul 2026
First PostedFeb 16, 2012
Enrollment StartMar 1, 2012
Primary CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 14.4 years ago
Interventions
Placebodrug
placebo matching tiotropium + olodaterol FDC
Tiotropiumdrug
Tiotropium 5 mcg once daily
Olodateroldrug
Olodaterol 5 mcg once daily
tiotropium + olodateroldrug
tiotropium + olodaterol 5 mcg once daily
Tiotropium + Olodateroldrug
Tiotropium 2.5 mcg + Olodaterol 5 mcg once daily
Respimatdevice
Respimat inhaler