The effects of enoximone in acute exacerbation COPD: a pilot study

Phase 1

• Conditions: Acute exacerbation of COPD; MedDRA version: 21.1Level: LLTClassification code 10010953Term: COPD exacerbationSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2019-002826-58-NL
• Lead Sponsor: Rijnstate Hospital, Arnhem

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-05
• Last Update Posted: 15 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Patients with an AE-COPD wherefore intubation occurred within 24 hours before enrollment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: a reduction in bronchoconstriction, measured by auto-PEEP, in patients with AE-COPD. ;Secondary Objective: To test for a dose-dependency. <br>Decrease in pulmonary artery pressures<br>Enhance cardiac output<br>Measure occurrence of side effects by enoximone administration <br>;Primary end point(s): Auto-PEEP in cmH2O;Timepoint(s) of evaluation of this end point: One hour after every enoximone dose

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Respiratory parameters:<br>- Lungcompliance in L/cmH2O <br>- Airway resistance in cmH2O/L/s<br>- VCO2<br>- etCO2<br>- FiO2<br><br>Cardiac parameters:<br>- RVSP<br>- Cardiac output<br>- TAPSE<br>- MAPSE<br><br>Arterial blood gas analysis (2 ml of blood, obtained through an arterial cannula):<br>- pH, PaCO2, PaO2, saturation, lactate, base excess, <br><br>Vital Signs:<br>- Occurrence of adverse side effects such as (supraventricular) arrhythmics and hypotension<br>;Timepoint(s) of evaluation of this end point: The respiratory variables are measured every 15 minutes for 5 hours after the first enoximone dose.<br>The cardiac variables and bloodgas analysis are measured every hour for 5 hours after the first enoximone dose<br>The vital signs are measured continously for 5 hours after the first enoximone dose.