drugset / Trial / NCT03104634

The Effects of Inhaled Aclidinium Bromide/Formoterol Fumarate on Inspiratory Pleural Pressures in Smokers

NCT03104634

RandomizedCrossoverQuadruple-blindTreatment

Summary

This short-term study aims to prove the potential cardio-protective physiological effect of inhaled aclidinium bromide/formoterol fumarate on inspiratory pleural pressures. Smoking is associated with gas-trapping (hyperinflation), even in the absence of chronic obstructive pulmonary disease. Breathing in the presence of gas-trapping requires large negative inspiratory pleural pressures, which are transmitted to the surface of the heart and increase cardiac wall stress. Inhaled aclidinium bromide and formoterol fumarate has been shown to reduce gas-trapping, but the impact on inspiratory pleural pressures and biomarkers of cardiac stress in smokers is unknown.

Timeline

Start
2017-05-01
Primary completion
2018-12-01
Completion
2019-02-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Aclidinium Small molecule 400 ug Inhaled
Subject Formoterol Other / unclassified 12 ug Inhaled

Indications

No indication recorded.