At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Exploratory, Randomised, Double-blind, Double-dummy, Active-controlled, Two Period Cross-over Study to Investigate the Effect of 6 Weeks Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (FDC) Delivered by the Respimat® Inhaler With Fluticasone Propionate + Salmeterol FDC Delivered by the Accuhaler® Inhaler, on Left Ventricular Function and Arterial Stiffness in Patients With Chronic Obstructive Pulmonary Disease (COPD)
In Brief
A Phase 4 clinical trial evaluating Tiotropium, Olodaterol, and 2 other interventions for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 76 participants across 10 sites.
Detailed Summary
The objectives of the study are to explore the effect of treatment with tiotropium + olodaterol fixed dose combination (FDC) compared to fluticasone propionate + salmeterol FDC on: * reversal of left ventricular diastolic dysfunction assessed with cardiac magnetic resonance (CMR) imaging, * measures of arterial stiffness assessed by CMR and pulse wave analysis (PWA), * reduction of hyperinflation assessed with body plethysmography and * post dose spirometry.
Study Details
Timeline
Interventions
Fixed Dose Combination
Fixed Dose Combination
Fixed Dose Combination
Fixed Dose Combination