Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Inhaled drug aims to save transplanted lungs from silent threat

NCT ID NCT04039347

Disease control Sponsor: Zambon SpA Source: ClinicalTrials.gov ↗

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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an inhaled form of cyclosporine A (L-CsA) added to standard care for lung transplant patients with bronchiolitis obliterans syndrome (BOS), a condition that scars the lungs' small airways. The goal was to see if the treatment could slow the decline in lung function over 24 to 48 weeks. The trial included 164 patients who had already completed earlier studies, but it was terminated early, so results are limited.

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

164 people

The number who actually took part.

Started

Mar 2020

Finished

Feb 2026

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 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: 1. Patients who have completed all visits through the End of Treatment Visit in either BOSTON-1 or BOSTON-2, did not withdraw informed consent, and did not prematurely terminate study drug administration. 2. Patients should be on a three-drug maintenance regimen of immunosuppressive agents including tacrolimus or another CNI, a second agent such as but not limited to MMF or azathioprine, and a systemic corticosteroid such as prednisone. 3. Patients capable of understanding the purposes and risks of the clinical trial, who have given written informed consent and agree to comply with the clinical trial requirements/visit schedules, and who are capable of aerosol inhalation. 4. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to Visit 1 and must agree to use one of the methods of contraception listed in Appendix II through their End of Study Visit. Exclusion Criteria: 1. Known hypersensitivity to L-CsA or to cyclosporine A. 2. Patients who experienced an AE related to study drug that led to permanent study drug discontinuation in BOSTON-1 or BOSTON-2. 3. Patients with new onset of malignancy while participating in BOSTON-1 or BOSTON-2, including post-transplant lymphoproliferative disorder, with the exception of treated, localized basal and squamous cell carcinomas. 4. Pregnant women or women who are unwilling to use appropriate birth control to avoid pregnancy through their End of Study Visit. 5. Women who are currently breastfeeding. 6. Receipt of an investigational drug, other than L-CsA, as part of a clinical trial within 4 weeks prior to Visit 1. This is defined as any treatment that is implemented under an Investigational New Drug (IND) or compassionate use. 7. Patients who are currently participating in an interventional clinical trial, other than BOSTON-1 or BOSTON-2. 8. Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary procedures. 9. Any co-existing medical condition that in the Investigator's judgment will substantially increase the risk associated with the patient's participation in the clinical trial.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Bronchiolitis obliterans are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Bronchiolitis Obliterans bronchiolitis obliterans syndrome

As listed by the trial registrant

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

Bronchiolitis obliterans Bronchiolitis obliterans syndrome Obliterative bronchiolitis

Contacts and locations

Locations

  • Banner - University Medical Center

    Phoenix, Arizona, 85006, United States

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110, United States

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Baylor University Medical Center

    Dallas, Texas, 75246, United States

  • CHU Hopital Nord

    Marseille, France

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Complexo Hospitalario de A Coruna

    A Coruña, Spain

  • Copenhagen University Hospital

    Copenhagen, Denmark

  • David Geffen School of Medicine at UCLA

    Los Angeles, California, 90095, United States

  • Duke University

    Durham, North Carolina, 27710, United States

  • Hannover Medical School

    Hanover, Germany

  • Hopital Marie Lannelongue

    Le Plessis-Robinson, 92350, France

  • Hopitaux Universitaires de Strasbourg

    Strasbourg, France

  • Hospital Marques de Valdecilla

    Santander, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, Spain

  • Hospital Universitario Puerta de Hierro - Unidad de Trasplante Pulmonar

    Madrid, 28222, Spain

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Hôpital Erasme

    Brussels, 1070, Belgium

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Johns Hopkins University Hospital

    Baltimore, Maryland, 21287, United States

  • LMU Klinikum Groshadern

    Munich, Germany

  • OSU Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • Rabin Medical Center

    Petah Tikva, Israel

  • Royal Papworth Hospital NHS Foundation Trust

    Cambridge, CB23 3RE, United Kingdom

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140, United States

  • UCSF

    San Francisco, California, 94143, United States

  • UCSF Center for Advanced Lung Disease

    Stanford, California, 94305, United States

  • UK Albert B. Chandler Hospital

    Lexington, Kentucky, 40508, United States

  • Unidad de Trasplante Pulmonar del Hospital La Fe

    Valencia, 46026, Spain

  • Universitair Ziekenhuis Leuven

    Leuven, 3000, Belgium

  • University of Florida Dept of Pulmonary Medicine

    Gainesville, Florida, 32610, United States

  • University of Manchester

    Manchester, United Kingdom

  • University of Maryland

    Baltimore, Maryland, 21201, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • Waehringer Guertel

    Vienna, Austria

More trials for these conditions

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