The Effects of Enoximone in Acute Exacerbation COPD

NCT04420455 | Terminated Phase 4

• 1 other identifier: 2019-1432
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD Exacerbation; Enoximone; Phosphodiesterase Inhibitor

Outcome Measures

Primary Outcomes (1)

• PEEP

  Reduction in intrinsic PEEP, in cmH2O

  within 6 hoursmeasured every 15 minutes

Secondary Outcomes (14)

• Lung compliance

  within 6 hours, measured every hour

• Airway resistence

  within 6 hours, measured every hour

• VEI

  within 6 hours, measured every hour

• VCO2

  within 6 hours, measured every hour

• etCO2

  within 6 hours, measured every hour

Study Arms (1)

Enoximone

EXPERIMENTAL

Patients will receive three times a dose of 0.5 mg/kg enoximone with a one-hour-interval.

Drug: Enoximone

Interventions

Enoximone DRUG

Patients will receive three times a dose of 0.5 mg/kg enoximone with a one-hour-interval.

Enoximone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with an AE-COPD for which intubation occurred within 24 hours before enrolment.

You may not qualify if:

• Patients with known asthma or interstitial lung disease (ILD)
• Known neurodegenerative diseases such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Guillain-Barre and Dementia
• Hypertrophic obstructive cardiomyopathy (HOCM)
• Severe aortic stenosis with aortic valve area \< 1cm2
• Known ventricular arrhythmias
• Severe kidney disorders with Glomerular Filtration Rate (GFR) \< 30
• Severe liver insufficiency with spontaneous PT/INR \> 1.5
• Pregnancy
• Lactation
• High dose-diuretics use (daily dose of \>480 mg furosemide)

Sponsors & Collaborators

• Rijnstate Hospital: lead

Study Sites (1)

M.V. Koning

Arnhem, M, Netherlands

Location

MeSH Terms

Interventions

Enoximone

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: June 9, 2020
• Study Start: May 12, 2020
• Primary Completion: December 21, 2021
• Study Completion: December 21, 2021
• Last Updated: January 13, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: after publication
• Access Criteria: upon reasonable request, available by the researchers

Locations

NL (1)