Effects of NEP Inhibition on Lung Inflammation and Fluid Leakage

Assessment of the Effect of Neutral Endopeptidase Inhibition on Vascular Leak and Leukocyte Accumulation in a Human Cantharidin Blister Model

This study is testing if a medication called Racecadotril can help reduce lung inflammation and fluid buildup in people with Acute Respiratory Distress Syndrome (ARDS).

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Queen Mary University of London (Academic / other)
• Locations: 1 site (London)
• Trial ID: NCT05600062 on ClinicalTrials.gov

What this trial studies

This study investigates the role of C-type natriuretic peptide (CNP) in managing Acute Respiratory Distress Syndrome (ARDS), a severe lung condition characterized by fluid accumulation in the lungs. The research will involve administering Racecadotril, a medication that may help maintain the integrity of blood vessel barriers, to assess its impact on vascular leak and inflammation in healthy volunteers. The study aims to provide insights into potential therapeutic approaches for ARDS, which currently lacks effective treatments.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy male and female volunteers aged 18-45 with a BMI of 18-40 kg/m2.

Not a fit: Patients with a history of serious illnesses, smokers, or those with specific skin conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new treatment options for patients suffering from Acute Respiratory Distress Syndrome.

How similar studies have performed: While this approach is novel in the context of ARDS, similar studies targeting vascular integrity have shown promise in other conditions.

Eligibility criteria

Inclusion Criteria:

1. Healthy male and female volunteers
2. BMI of 18-40 kg/m2
3. Aged 18-45
4. Volunteers who are willing to sign the consent form

Exclusion Criteria:

1. Healthy subjects unwilling to consent
2. Smokers
3. Known sensitivity to Racecadotril
4. History of any serious illnesses, including recent infections or trauma
5. A personal history of keloid scarring, or a family history of keloid scarring in a first degree relative with similar skin pigmentation
6. Subjects taking systemic medication (other than the oral contraceptive pill)
7. Subjects who are pregnant or any possibility that a subject may be pregnant, unless in the latter case a pregnancy test is performed with a negative result
8. Women who are breastfeeding
9. Subjects with recent or current antibiotic use
10. Subjects with a history of skins conditions.
11. Subjects with a history of allergic reaction to any topical application or history of angioedema
12. Subjects with any history of a blood-borne infectious disease such Hepatitis B or C virus, or HIV.

Where this trial is running

London

• William Harvey Research Institute- Heart Centre — London, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Adrian Hobbs — Queen Mary University London
• Study coordinator: Aemun Salam, MBBS, MRCP, FFICM

Conditions Acute Respiratory Distress Syndrome; ARDS; endothelium; CNP; Acute lung injury