drugset / Trial / NCT04420455

The Effects of Enoximone in Acute Exacerbation COPD

NCT04420455

Phase 4 Terminated 3 enrolled Rijnstate Hospital
NaSingle-groupOpen-labelTreatment

Summary

Introduction: The pharmacodynamic properties of enoximone could be beneficial for patients with an Acute Exacerbation COPD (AE-COPD). This research will focus on patients suffering of a severe AE-COPD and the bronchodilatory and inotropic effects of lower doses of enoximone. The main objective of the pilot study is to investigate if there is a bronchodilatory effect of enoximone in patients with AE-COPD. Secondary objective is to investigate a dose responsiveness in a range between 0.5 and 1.5 mg/kg enoximone. Methods: The study design is a prospective interventional non-randomized clinical series study involving patients admitted and intubated at the Intensive Care Unit (ICU) with an AE-COPD. Patients will receive three times a dose of 0.5 mg/kg enoximone with a one-hour-interval. The primary objective is a reduction in auto-positive end-expiratory pressure (PEEP) after enoximone compared to baseline. A dose-titration will test for dose dependency. Secondary objectives are a reduction in ventilator pressures, a reduction in pulmonary artery pressures and an increase in cardiac output.

Timeline

Start
2020-05-12
Primary completion
2021-12-21
Completion
2021-12-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Enoximone Small molecule 0.5 mg/kg