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Inhaled DNA-buster may shield trauma patients from lung failure

NCT ID NCT03368092

Prevention Sponsor: University Hospital, Strasbourg, France Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial tests whether giving an inhaled medication called dornase alfa to severely injured patients on breathing machines can lower their risk of developing acute respiratory distress syndrome (ARDS), a serious lung condition. The drug is thought to break down DNA fragments released after trauma that can trigger lung inflammation. Half of the 500 participants will receive the drug, and half will receive a placebo, with the goal of seeing if the drug reduces ARDS cases from 45% to 30% in the first week.

What this could mean

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

Active substance
Dornase alfa (Pulmozyme), an inhaled enzyme that breaks down DNA, given as an aerosol in the breathing circuit.
What this could lead to
If effective, this could become a simple, early treatment to prevent a life-threatening lung complication in trauma patients, potentially reducing ICU stays and deaths.
What could go wrong
This is a phase 3 trial, but success is not guaranteed. The treatment may not reduce ARDS risk, and side effects or complications from the aerosol could occur.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 500 people

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

Started

Mar 2019

Expected to finish

Dec 2027

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 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Adult (\>18) patient of either sex affiliated to the National Health Service * Severe trauma patient (either blunt or penetrating), Injury Severity Score \> 15 * Under mechanical ventilation for an expected duration \> 48h * Admitted in the ICU * Signed informed consent from the patient's relative * Patient equipped with an indwelling arterial catheter Exclusion Criteria: * Pregnancy or breast feeding * Opposition from the patient or his/her relatives * Protected major (Guardianship) * Contraindication to the use of dornase alfa * Known intolerance to dornase alfa

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Conditions

The condition(s) this trial relates to.

adult acute respiratory distress syndrome injury Multiple Trauma acute respiratory distress syndrome prevention target

As listed by the trial registrant

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

Multiple trauma Respiratory distress syndrome, adult

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University Hospital, Strasbourg, france

    RECRUITING

    Strasbourg, 67000, France

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