Acute Respiratory Distress SyndromeNCT05600062
Influence of NEP Inhibition on Vascular Leak and Inflammation (NEPi-INFLAMMATION)
A study testing Racecadotril 100 milligram (MG) Oral Capsule in people with Acute Respiratory Distress Syndrome, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
Acute Respiratory Distress Syndrome (ARDS) is a severe type of lung injury that affects 10% of patients admitted to Intensive Care Units worldwide, with an unacceptably high mortality of up to 48% in those with the most severe form of the condition. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Racecadotril 100 milligram (MG) Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Mar 2023to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female volunteers
- BMI of 18-40 kg/m2
- Aged 18-45
- Volunteers who are willing to sign the consent form
Who cannot join
- Healthy subjects unwilling to consent
- Smokers
- Known sensitivity to Racecadotril
- History of any serious illnesses, including recent infections or trauma
- A personal history of keloid scarring, or a family history of keloid scarring in a first degree relative with similar skin pigmentation
- Subjects taking systemic medication (other than the oral contraceptive pill)
Show all 12Show fewer
- 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
- Women who are breastfeeding
- Subjects with recent or current antibiotic use
- Subjects with a history of skins conditions.
- Subjects with a history of allergic reaction to any topical application or history of angioedema
- Subjects with any history of a blood-borne infectious disease such Hepatitis B or C virus, or HIV.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
William Harvey Research Institute- Heart Centre
London
About this study
Official title: Assessment of the Effect of Neutral Endopeptidase Inhibition on Vascular Leak and Leukocyte Accumulation in a Human Cantharidin Blister Model
Acute Respiratory Distress Syndrome (ARDS) is a severe type of lung injury that affects 10% of patients admitted to Intensive Care Units worldwide, with an unacceptably high mortality of up to 48% in those with the most severe form of the condition. It is a complex and poorly understood syndrome that results in progressive failure of the lungs. Crucially, the inflamed lungs allow fluid to leak from the circulation into the airspace, so that patients' lungs fill with fluid - "drowning from the inside". As this condition progresses, the patient typically requires increasing amounts of oxygen and eventually, support from a ventilator. To date, there are no effective treatments for ARDS that can limit, stop or repair this process.
This research study is aiming to look at a naturally occurring substance produced by blood vessels, C-type natriuretic peptide (CNP). The investigators have evidence suggesting that CNP plays a role in maintaining the barrier provided by blood vessels that stops fluid leaking out into tissues. This is based on various studies done on CNP by the investigators research group that have established its widespread role in maintaining cells that line blood vessels and play a vital role in lungs' barrier function: the endothelium.
CNP is broken down in part by an enzyme called Neutral endopeptidase and therefore, drugs that inhibit this enzyme would result in increased CNP concentration and activity. If CNP does in fact strengthen the lungs' endothelial barrier, then this class of drug may benefit patients with ARDS. The aim of this experimental medicine study is to assess the effect of using the licensed NEP inhibitor Racecadotril, in a well-established, safe model of inflammation-induced skin blisters in healthy human volunteers to determine primarily whether the fluid accumulation i.e. leak, in these blisters is reduced by treatment with this drug.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Racecadotril 100 milligram (MG) Oral Capsule, Placebo
- Keywords
- ARDS, endothelium, CNP, Acute lung injury
- Medical subject headings
- Respiratory Distress Syndrome, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Racecadotril 100 milligram (MG) Oral CapsuleDrug
Also called Tiorfan
Licensed NEP inhibitor
PlaceboDrug
Placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo tablet to be taken three times a day for three days Receives: Drug: Placebo |
| Racecadotril | Experimental | Racecadotril 100 milligrams (mg) three times a day for three days Receives: Drug: Racecadotril 100 milligram (MG) Oral Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Powered unpaired inter-patient comparison of change in blister fluid volume following Racecadotril or placebo administration.
Measured: 24 hours after application of cantharidin
Powered paired intra-patient comparison of change in blister fluid volume following Racecadotril or placebo admininstration.
Measured: 24 hours after application of cantharidin
Secondary outcomes (5)
Powered comparison of sex differences in change in blister volume following Racecadotril or placebo administration.
Measured: End of study
Difference in concentration of blister fluid cytokines; specifically Interleukin (IL) -1β, IL-6, IL-8, IL-10, CXCL1, CXCL2, CCL5 and CCL2 in volunteers receiving Racecadotril compared to placebo.
Measured: 24 hours after application of cantharidin
Comparison of change in blister fluid leukocyte count following Racecadotril or placebo administration
Measured: 24 hours after application of cantharidin
Comparison of change in pro and anti-inflammatory mediators from blister fluid following Racecadotril or placebo administration
Measured: 24 hours after application of cantharidin
Comparison of change in plasma cGMP following oral Racecadotril or placebo administration
Measured: 24 hours after application of cantharidin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start21 Mar 2023
- Primary completion1 Feb 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council
- Responsible party
- Sponsor
- Investigators
- Adrian Hobbs, Principal investigator, Queen Mary University London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05600062
- Sponsor's protocol ID
- 288749
- Status last verified
- Oct 2026
- First submitted
- 3 Oct 2022
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Fully anonymised data will be shared with fellow researchers via conference presentation and via publication of the results in scientific journals. Data will be shared between the research team directly undertaking the research
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effect of Neutral Endopeptidase Inhibition on Vascular Leak and Leukocyte Accumulation in a Human Cantharidin Blister Model
- ClinicalTrials.gov ID
- NCT05600062
- Acronym / sponsor ID
- 288749
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- ARDS, endothelium, CNP, Acute lung injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- Medical Research Council
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 31 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute Respiratory Distress Syndrome (ARDS) is a severe type of lung injury that affects 10% of patients admitted to Intensive Care Units worldwide, with an unacceptably high mortality of up to 48% in those with the most severe form of the condition. It is a complex and poorly understood syndrome that results in progressive failure of the lungs. Crucially, the inflamed lungs allow fluid to leak from the circulation into the airspace, so that patients' lungs fill with fluid - "drowning from the inside". As this condition progresses, the patient typically requires increasing amounts of oxygen and eventually, support from a ventilator. To date, there are no effective treatments for ARDS that can limit, stop or repair this process.
This research study is aiming to look at a naturally occurring substance produced by blood vessels, C-type natriuretic peptide (CNP). The investigators have evidence suggesting that CNP plays a role in maintaining the barrier provided by blood vessels that stops fluid leaking out into tissues. This is based on various studies done on CNP by the investigators research group that have established its widespread role in maintaining cells that line blood vessels and play a vital role in lungs' barrier function: the endothelium.
CNP is broken down in part by an enzyme called Neutral endopeptidase and therefore, drugs that inhibit this enzyme would result in increased CNP concentration and activity. If CNP does in fact strengthen the lungs' endothelial barrier, then this class of drug may benefit patients with ARDS. The aim of this experimental medicine study is to assess the effect of using the licensed NEP inhibitor Racecadotril, in a well-established, safe model of inflammation-induced skin blisters in healthy human volunteers to determine primarily whether the fluid accumulation i.e. leak, in these blisters is reduced by treatment with this drug.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablet to be taken three times a day for three days |
| Racecadotril | Experimental | Drug: Racecadotril 100 milligram (MG) Oral CapsuleRacecadotril 100 milligrams (mg) three times a day for three days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male and female volunteers
- BMI of 18-40 kg/m2
- Aged 18-45
- Volunteers who are willing to sign the consent form
Key exclusion criteria (12 listed)
- Healthy subjects unwilling to consent
- Smokers
- Known sensitivity to Racecadotril
- History of any serious illnesses, including recent infections or trauma
- A personal history of keloid scarring, or a family history of keloid scarring in a first degree relative with similar skin pigmentation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Racecadotril 100 milligram (MG) Oral CapsuleAlso: TiorfanLicensed NEP inhibitor | Drug | Racecadotril |
| PlaceboPlacebo capsule | Drug | Placebo |
Primary outcome
Powered unpaired inter-patient comparison of change in blister fluid volume following Racecadotril or placebo administration.
Time frame: 24 hours after application of cantharidin
Powered paired intra-patient comparison of change in blister fluid volume following Racecadotril or placebo admininstration.
Time frame: 24 hours after application of cantharidin
5 secondary outcomes
Powered comparison of sex differences in change in blister volume following Racecadotril or placebo administration.
Time frame: End of study
Difference in concentration of blister fluid cytokines; specifically Interleukin (IL) -1β, IL-6, IL-8, IL-10, CXCL1, CXCL2, CCL5 and CCL2 in volunteers receiving Racecadotril compared to placebo.
Time frame: 24 hours after application of cantharidin
Comparison of change in blister fluid leukocyte count following Racecadotril or placebo administration
Time frame: 24 hours after application of cantharidin
Comparison of change in pro and anti-inflammatory mediators from blister fluid following Racecadotril or placebo administration
Time frame: 24 hours after application of cantharidin
Comparison of change in plasma cGMP following oral Racecadotril or placebo administration
Time frame: 24 hours after application of cantharidin
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Yes. Fully anonymised data will be shared with fellow researchers via conference presentation and via publication of the results in scientific journals. Data will be shared between the research team directly undertaking the research
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian Hobbs principal investigator
Queen Mary University London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Racecadotril 100 milligram (MG) Oral Capsule in people with Acute Respiratory Distress Syndrome, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Powered unpaired inter-patient comparison of change in blister fluid volume following Racecadotril or placebo administration. (time frame: 24 hours after application of cantharidin). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.