Active not recruitingNAINTERVENTIONAL

Influence of NEP Inhibition on Vascular Leak and Inflammation (NEPi-INFLAMMATION)

This study, called NEPi-INFLAMMATION, is investigating a potential new treatment for Acute Respiratory Distress Syndrome (ARDS), a serious lung condition where fluid leaks into the lungs, making it hard to breathe. Currently, there are no effective treatments for ARDS, which affects many intensive care patients worldwide and can be life-threatening. We're focusing on a natural substance in our bodies called C-type natriuretic peptide (CNP), which our research suggests helps keep blood vessels from leaking. A drug called Racecadotril works by increasing the amount of CNP in the body. We want to see if this drug can reduce fluid leaking into the skin of healthy volunteers. This could eventually lead to a treatment for ARDS patients, helping to stop their lungs from filling with fluid.

At a glance

Status

Active not recruiting

Phase

Sponsor

Queen Mary University of London

Enrolment target

Start

21 Mar 2023

Estimated completion

15 Jun 2026

Acute Respiratory Distress Syndrome

What is this study about?

Acute Respiratory Distress Syndrome, or ARDS, is a very serious lung condition that causes severe breathing problems. It often affects people who are already very unwell and are in intensive care. Sadly, ARDS can be life-threatening, and currently, there isn't a specific treatment that can stop or reverse the damage it causes.

When someone has ARDS, their lungs become very inflamed and damaged. This damage allows fluid from the blood vessels to leak into the air sacs of the lungs, almost like small holes appear. This makes it feel like the person is 'drowning from the inside' as their lungs fill with fluid, making it incredibly difficult to breathe. Over time, patients often need more and more oxygen and might even require a breathing machine (ventilator) to help them.

Our research is looking at a natural substance called C-type natriuretic peptide, or CNP, which is found in our blood vessels. We believe that CNP plays an important role in keeping the walls of our blood vessels strong and preventing fluid from leaking out. There's an enzyme in the body that naturally breaks down CNP. We're testing a drug called Racecadotril, which works by blocking this enzyme. This means that if you take Racecadotril, your body should have more CNP. We hope that by increasing CNP, we can strengthen the blood vessel walls in the lungs and reduce the fluid leakage seen in ARDS. This study in healthy volunteers is an important first step to see if this idea works.

Key takeaways

This study aims to find a new treatment for ARDS, a severe lung failure.
ARDS causes fluid to leak into the lungs, making breathing very difficult.
Researchers are testing a drug called Racecadotril in healthy volunteers.
Racecadotril is thought to strengthen blood vessels to prevent fluid leakage.
The study uses carefully controlled skin blisters to test the drug's effect on fluid leakage.
Your participation could help develop life-saving treatments for ARDS patients.

Who may be eligible?

To make sure this study is safe and the results are clear, we need certain types of volunteers. We're looking for healthy men and women between the ages of 18 and 45. Your body mass index (BMI) should also be between 18 and 40. You must be willing to understand the study and sign a consent form to take part.

There are also some reasons why you wouldn't be able to join. For example, if you smoke, have known allergies to the study drug (Racecadotril), or have had serious illnesses in the past, you wouldn't be suitable. We also can't include you if you're taking most other medications (except the oral contraceptive pill), if you are pregnant, might be pregnant (unless a test is negative), or are breastfeeding. People with certain skin conditions, a history of unusual scarring (keloids) in themselves or their close family, or serious infections like Hepatitis B or HIV, also cannot participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 45 years old?
Are you a healthy non-smoker?
Do you have a BMI between 18 and 40?
Are you NOT pregnant, breastfeeding, or planning to become pregnant during the study?
Are you NOT allergic to Racecadotril or do you have a history of serious illnesses or skin conditions?
Are you NOT taking any regular medications (other than the oral contraceptive pill)?

Answer every question to see your result.

What does participation involve?

This study involves healthy volunteers. The full details of what taking part would involve will be shared before you decide to join. However, you can expect to receive either an oral capsule of Racecadotril (100mg) or a placebo (a dummy pill with no active drug). You will be closely monitored by the research team. The study will involve assessing how fluid accumulates in inflammation-induced skin blisters, which will be carefully created and monitored under medical supervision. This will help us understand if the drug can reduce fluid leakage. The total duration of your participation, including any follow-up appointments, will be clearly explained within the consent process.

Potential risks and benefits

Participating in this study may not directly benefit your health, as it is an early-stage study in healthy volunteers. However, your involvement is crucial for helping us understand if this drug could eventually become a treatment for ARDS, a very serious lung condition. As with any study involving medication, there's a possibility of side effects, although Racecadotril is an approved drug for other conditions and generally well-tolerated. All procedures will be explained in detail, along with any potential risks, before you agree to participate. You are free to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

William Harvey Research Institute- Heart Centre
Verified postcode
London, United Kingdom

Common questions

What is ARDS?

ARDS (Acute Respiratory Distress Syndrome) is a severe lung condition where the lungs fill with fluid, making it very hard to breathe. It affects people who are already very ill, often in intensive care.

What is Racecadotril?

Racecadotril is a medication that's already approved for other uses. In this study, we're exploring if it can help stop fluid leaking into the lungs by boosting a natural substance in the body.

Why are you studying healthy people, not ARDS patients?

This is an early-stage experiment to understand how the drug works on fluid leakage in a very controlled way. If it shows promise in healthy volunteers, it could then be studied in ARDS patients in the future.

Will I get the actual drug or a dummy pill?

Participants will be chosen at random to receive either the Racecadotril drug or a placebo (a dummy pill with no active medication). You won't know which one you receive until after the study.

What does 'inflammation-induced skin blisters' mean?

This refers to a small, controlled way we can cause a temporary, minor inflammation on the skin. This allows us to safely study how the drug affects fluid leakage in a small-scale model, replacing the need for more complex procedures.