Inhaled cyclosporine aims to halt lung transplant rejection

NCT ID NCT03656926

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

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial tested whether adding inhaled liposomal cyclosporine A to standard care can improve lung function in 169 double lung transplant patients with chronic rejection. Participants inhaled the drug twice daily for 48 weeks. The main goal was to see if it slowed the decline in how much air they can exhale in one second (FEV1).

What this could mean

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

Active substance: Liposomal cyclosporine A (inhaled)
What this could lead to: If it works, this could offer a new treatment option to slow lung function decline in double lung transplant patients with chronic rejection.
What could go wrong: This is a completed Phase 3 trial, but results may not show significant benefit over standard care. Inhaled cyclosporine may cause side effects like cough or infection.

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

169 people

The number who actually took part.

Started

Mar 2019

Finished

Mar 2024

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: Patients who met the following criteria as stated in the protocol were included in the study: 1. Adult patients of \> or = 18 years who received a DLT at least 12 months prior to Screening. 2. Patients with BOS diagnosis defined as CLAD-BOS phenotype with: 1. screening FEV1 between 51% and 85% of personal best FEV1 value post-transplant OR 2. screening FEV1 \> 85% of personal best FEV1 associated with EITHER a \> or = 200 mL decrease in FEV1 in the previous 12 months OR according to medical history showing BOS progression. 3. Diagnosis of CLAD-BOS must have been made at least 12 months after lung transplantation and 1. within 12 months prior to the Screening Visit OR 2. more than 12 months from Screening and patient must have shown a decline in FEV1 \>or = 200 ml in the previous 12 months before Screening, which was not due to acute infection or acute organ rejection. 4. Patients in whom the diagnosis of BOS had been confirmed by the elimination of other possible causes of obstructive or restrictive lung disease CLAD - restrictive allograft syndrome (RAS) phenotype. 5. Patients should have been on a drug maintenance regimen of immunosuppressive agents including tacrolimus, a second agent such as but not limited to MMF or azathioprine, and a systemic corticosteroid such as prednisone as third agent. The regimen must have been stable within 4 weeks prior to randomization with respect to the therapeutic agents. In case a patient was also receiving concomitant azithromycin for prophylaxis or treatment of BOS, in addition to the previously described immunosuppressive regimen, azithromycin must have been on a stable regimen for at least 4 weeks prior to randomization. 6. Patients capable of understanding the purposes and risks of the clinical trial, who had given written informed consent and agreed to comply with the clinical trial requirements/visit schedules, and who were capable of aerosol inhalation. Patients must have consented to retrieve prespecified data from the historic medical record (e.g., information related to the transplant surgery; spirometry data; medication use). 7. Women of childbearing potential must have had a negative serum or urine pregnancy test within 7 days prior to randomization and must have agreed to use one of the methods of contraception listed in Appendix II of the protocol in Appendix 16.1.1 through their EoS Visit. 8. Patients had no concomitant diagnoses that were considered fatal within one year (12 months) of Screening. Exclusion Criteria: 1. Patients with confirmed other causes for loss of lung function, such as acute infection, acute rejection, restrictive allograft syndrome (RAS) (CLAD - RAS phenotype, see Protocol Specific Definition ), etc. 2. Cystic Fibrosis patients with multi-drug resistant infections not responding to available anti-microbial therapies. 3. Patients with acute antibody-mediated rejection at Screening. In this context, clinically stable patients (as judged by the Investigator) with detectable levels of donor specific antibodies (DSA) at the Screening Visit are eligible for the study. 4. Active acute bacterial, viral, or fungal infection not successfully resolved at least 4 weeks prior to the Screening Visit. Patients with chronic infection or colonization who are clinically stable as per judgement of the Investigator are eligible for the study. 5. Mechanical ventilation (including CPAP) within 12 weeks prior to Randomization. 6. Patients with uncontrolled hypertension. 7. Patient has baseline resting oxygen saturation of \< 89% on room air or use of supplemental oxygen at rest. 8. Evidence of functional airway stenosis (e.g., bronchomalacia/tracheomalacia, airway stents, or airways requiring balloon dilatations to maintain patency) with onset after the initial diagnosis of BOS and ongoing at Screening and/or Randomization Visit. 9. Known hypersensitivity to L-CsA or to cyclosporine A. 10. Patients with chronic renal failure, defined as serum creatinine \> 2.5 mg/dL at screening, or requiring chronic dialysis. 11. Patients with liver disease and serum bilirubin \> 3-fold upper limit of normal range or transaminases \> 2.5 upper limit of normal range. 12. Patients with active malignancy within the previous 2 years, including post-transplant lymphoproliferative disorder, with the exception of treated, localized basal and squamous cell carcinomas. 13. Pregnant women or women who are unwilling to use appropriate birth control to avoid pregnancy through their End of Study Visit. 14. Women who are currently breastfeeding. 15. Receipt of an investigational drug as part of a clinical trial within 4 weeks prior to the Screening Visit. This is defined as any treatment that is implemented under an Investigational New Drug (IND) or compassionate use. 16. Patients who have received extracorporeal photophoresis (ECP) for treatment of BOS within 1 month prior to Randomization. 17. Patients who are currently participating in an interventional clinical trial. 18. Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary procedures. 19. 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

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Bronchiolitis Obliterans bronchiolitis obliterans syndrome chronic transplant rejection Rejection, Psychology transplant rejection transplant-related bronchiolitis obliterans

As listed by the trial registrant

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

Bronchiolitis obliterans Chronic lung allograft dysfunction Chronic rejection of lung transplant Lung transplant failure and rejection Lung transplant rejection Lung transplant; complications

Contacts and locations

Locations

Banner Health

Phoenix, Arizona, 85013, United States
Baylor College of Medicine

Houston, Texas, 77030, United States
Baylor University Medical Center

Dallas, Texas, 75246, United States
CHU Erasme

Brussels, Belgium
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
Duke University Medical Center

Durham, North Carolina, 27110, United States
Hannover Medical School

Hanover, Germany
Hospital Marques de Valdecilla

Santander, Spain
Hospital Puerta de Hierro

Madrid, Spain
Hospital Universitari Vall d'Hebron

Barcelona, Spain
Hospital Universitario 12 de Octubre

Madrid, 28041, Spain
Hospital Universitario Reina Sofía

Córdoba, 14004, Spain
Houston Methodist Hospital

Houston, Texas, 77030, United States
Hôpitaux Universitaires de Strasbourg

Strasbourg, France
Indiana University

Indianapolis, Indiana, 46202, United States
Johns Hopkins University Hospital

Baltimore, Maryland, 21287, United States
LMU Klinikum Großhadern

Munich, Germany
Marie-Lannelongue

Le Plessis-Robinson, 92350, France
Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States
Medical University of Vienna

Vienna, Austria
Ohio State University Medical Center

Columbus, Ohio, 43210, United States
Rabin Medical Center

Petah Tikva, Israel
Royal Papworth Hospital

Cambridge, United Kingdom
Stanford University Hospital

Palo Alto, California, 94305, United States
Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States
UC San Francisco

San Francisco, California, 94143, United States
UCLA Medical Center

Los Angeles, California, 90095, United States
Universitair Ziekenhuis Leuven

Leuven, 3000, Belgium
University Hospital LA Fe

Valencia, Spain
University of Florida Medical Center

Gainesville, Florida, 32608, United States
University of Kentucky Albert B. Chandler Hospital

Lexington, Kentucky, 40508, 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 South Florida

Tampa, Florida, 33606, United States
Washington University

St Louis, Missouri, 63110, United States

More trials for these conditions

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