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Could a skin blister test lead to a treatment for 'Drowning from the Inside'?

NCT ID NCT05600062

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a drug called racecadotril can reduce fluid leakage in skin blisters, as a model for what happens in the lungs during Acute Respiratory Distress Syndrome (ARDS). ARDS is a severe lung injury with no effective drug treatments, where patients' lungs fill with fluid. The trial involves 48 healthy volunteers and uses a safe blister-inducing substance to measure whether the drug strengthens blood vessel barriers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Racecadotril (an oral capsule that blocks an enzyme called neutral endopeptidase)
What this could lead to
If this drug reduces fluid leak in the blister model, it could point toward a new treatment for ARDS, a severe lung condition with no current drug therapy.
What could go wrong
This is an early-stage study in healthy volunteers, not ARDS patients. The skin blister model may not fully reflect what happens in the lungs, and the drug may not work in real ARDS cases.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 48 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2023

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • William Harvey Research Institute- Heart Centre

    London, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.