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

Phase 1

Active, not recruiting

• 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

• Study Start: 2020-02-05
• Last Update Posted: 2020-06-15

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