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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002826-58-NL

Enrollment

Registered

2020-02-05

Start date

2020-02-05

Completion date

Unknown

Last updated

2020-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute exacerbation of COPD MedDRA version: 21.1 Level: LLT Classification code 10010953 Term: COPD exacerbation System Organ Class: 100000004855

Interventions

Trade Name: Enoximone Pharmaceutical Form: Concentrate for solution for injection/infusion INN or Proposed INN: ENOXIMONE CAS Number: 77671-31-9 Concentration unit: mg/ml milligram(s)/millilitre Conce

Eligibility

Sex/Gender

All

Inclusion criteria

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

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 1.5 Pregnancy

Design outcomes

Primary

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

Measure

Time frame

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

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Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Contacts

Public ContactMV Koning

Rijnstate Hospital, Arnhem

MVKoning@rijnstate.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026