At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 291 enrolled
Drug / intervention
Placebo +5 moredrug
Likely dose
Tiotropium + Olodaterol 2.5 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 2]
In Brief
A Phase 3 clinical trial evaluating Placebo, Tiotropium + Olodaterol, and 4 other interventions for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 291 participants across 33 sites in 8 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, Austria, Canada, Germany, Netherlands, Russia, Sweden, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2012
First PostedFeb 2012
Primary CompletionNov 2013
TodayJul 2026
First PostedFeb 16, 2012
Enrollment StartFeb 1, 2012
Primary CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.4 years ago
Interventions
Placebodrug
placebo matching tiotropium + olodaterol
Tiotropium + Olodateroldrug
Tiotropium 2.5 mcg + olodaterol 5 mcg once daily
tiotropium + Olodateroldrug
tiotropium 5 mcg + olodaterol 5 mcg once daily
Tiotropiumdrug
tiotropium
Olodateroldrug
Olodaterol 5 mcg once daily
Respimatdevice
Respimat inhaler