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New inhaled therapy aims to stop lung decline after transplant

NCT ID NCT05654922

Disease control Sponsor: Renovion, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Aug 06, 2026 · Updated 3 times

Summary

This Phase 3 trial tests an inhaled drug called ARINA-1 in 100 people who have had a double lung transplant and are showing early signs of lung function loss. The goal is to see if adding ARINA-1 to standard care can prevent further decline in lung function and improve quality of life over 48 weeks.

What this could mean

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

Active substance
ARINA-1 (a nebulized mix of ascorbic acid and glutathione)
What this could lead to
If it works, this could offer a new way to slow or stop lung function decline in lung transplant patients, potentially reducing the need for stronger immune-suppressing drugs.
What could go wrong
This is a Phase 3 trial, but it's still relatively small (100 people) and open-label, which can bias results. The treatment may not work better than standard care, and side effects from the inhaled drug are possible.

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 100 people

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

Started

Apr 2023

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 75 years

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: 1. Bilateral lung transplant \>12 months from the time of Visit 1 / Randomization 2. Age 18-75 years old at the time of consent 3. Routinely followed at enrolling site 4. Willing and able to comply with visit schedule and at-home requirements 5. 10-24% decrease in FEV1 from the post-transplant baseline within the last 12 months. 6. Capable of giving informed consent 7. On a stable maintenance regimen of azithromycin for \>4 weeks prior to the Screening Visit 8. On a stable 2-agent or 3-agent immunosuppression regimen that includes a steroid, a calcineurin inhibitor (CNI), and, optionally, a cell cycle inhibitor (e.g., mycophenolate, azathioprine) \>4 weeks prior to Screening 9. If a woman of childbearing potential (WOCBP), must agree to use a reliable method of birth control for the entire duration of the study. Exclusion Criteria: 1. Positive urine pregnancy test at screening and baseline visit 2. Diagnosis of active congestive heart failure or symptomatic coronary artery disease \> grade 3 based on the New York Heart Association Functional Classification (NYHA) criteria 3. Restrictive allograft syndrome (RAS) defined by radiographic interstitial or alveolar opacities on chest X-ray or CT scan that are consistent with RAS 4. Have advanced BOS, defined by \>24% decrease in FEV1 in post-transplant baseline 5. A diagnosis of probable antibody-mediated rejection (AMR) \<12 months prior to the baseline visit 6. Donor-specific antibodies (DSA) identified \<6 months prior to the baseline visit. \*The presence of DSA \>6 months from the baseline visit is acceptable for enrollment into the study. 7. Unresolved diffuse alveolar damage 8. Receiving mechanical ventilation 9. Chronic kidney disease stage IV or higher, including on dialysis 10. Initiating a new maintenance therapy or changing immunosuppression maintenance therapy (e.g., changing tacrolimus to cyclosporine) \<30 days prior to the baseline visit. 11. Have initiated or changed mTOR maintenance therapy \<3 months prior to Clinic Visit 1 (mTOR use for \>3 months is allowed) 12. Initiating or changing antibiotic (including azithromycin), antiviral, or antifungal therapy \<14 days prior to the baseline visit. 13. Use of alemtuzumab \<6 months prior to the baseline visit 14. Use of anti-thymocyte therapies (e.g., anti-thymocyte globulin) or photopheresis \<90 days prior to the Screening Visit. Prior use of Trikafta (elexacaftor, ivacaftor, and tezacaftor is allowed as long as the participant has been on stable dose for \>90 days prior to the Screening Visit. 15. Initiating a multivitamin or other supplement (inhaled, oral, or IV) containing vitamin C, glutathione, or N-acetylcysteine \<90 days prior to the baseline visit 16. Significant unstable comorbidities, in the opinion of the site investigator 17. Allery or previous adverse reaction to azithromycin 18. A diagnosis of dynamic collapse / tracheobrochomalacia \<90 days of the baseline visit. 19. Subjects currently participating in, or who have participated in an interventional (drug or device) clinical study \<30 days of the baseline visit. 20. Have been diagnosed with ARAD within 6 weeks of the Screening Visit. 21. Have used belatacept \<6 months prior to Clinic Visit 1 22. Have had an initial treatment of bronchial stents or cryotherapy within 12 months of the Screening Visit, or had bronchial stents removed within the last 3 months of the Screening Visit.

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Conditions

The condition(s) this trial relates to.

bronchiolitis obliterans syndrome prevention target

As listed by the trial registrant

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

Pre-bronchiolitis obliterans syndrome

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    20 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Advent Health

    RECRUITING

    Orlando, Florida, 32803, United States

  • Baylor Scott and White Research Institute

    RECRUITING

    Dallas, Texas, 75246, United States

  • Baylor St. Luke's Medical Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Columbia University Irving Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Dignity Health - St. Joseph's Hospital and Medical Center

    WITHDRAWN

    Phoenix, Arizona, 85013, United States

  • Houston Methodist Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • Inova Fairfax Hospital

    RECRUITING

    Falls Church, Virginia, 22042, United States

  • Johns Hopkins Hospital

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Loyola University Medical Center

    RECRUITING

    Maywood, Illinois, 60153, United States

  • Mayo Clinic

    NOT_YET_RECRUITING

    Rochester, Minnesota, 55905, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29452, United States

  • Temple University Hospital

    RECRUITING

    Philadelphia, Pennsylvania, 19122, United States

  • The Ohio State University Wexner Medical Center

    RECRUITING

    Columbus, Ohio, 43221, United States

  • University of California Los Angeles School of Medicine

    RECRUITING

    Los Angeles, California, 90095, United States

  • University of California San Diego Health

    RECRUITING

    San Diego, California, 92103, United States

  • University of Iowa Hospital

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Minnesota Medical School

    WITHDRAWN

    Minneapolis, Minnesota, 55455, United States

  • University of South Florida

    RECRUITING

    Tampa, Florida, 33606, United States

  • University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 45390, United States

  • Vanderbilt University Medical Center

    NOT_YET_RECRUITING

    Nashville, Tennessee, 37232, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States