drugset / Trial / NCT04231214

Effects of Spiolto® Respimat® (Tiotropium/Olodaterol) on Cardiac Function in Hyperinflated COPD Subjects

NCT04231214

RandomizedCrossoverDouble-blindTreatment

Summary

The purpose of this study is to examine the effect of a combined LABA/LAMA treatment with olodaterol/tiotropium on small airway function, autonomic nervous system and cardiac function in COPD. The main objective is to study the acute effect of dual bronchodilation with olodaterol/tiotropium on cardiac function measured by MRI. This work is unique as it assesses the effects of Spiolto® Respimat® on the left-ventricular end-diastolic volume and muscle sympathetic nerve activity, two endpoints relevant for cardiovascular disease. Furthermore, the study concept introduces exhaled particle analysis as a measure for small airway function, thus offering the opportunity for a mechanistic link between airway openness, hyperinflation, and cardiac function.

Timeline

Start
2020-01-28
Primary completion
2023-04-18
Completion
2023-04-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Olodaterol Small molecule 5 ug Inhaled
Subject Tiotropium Other / unclassified 5 ug Inhaled