Inhaled cyclosporine aims to halt lung transplant rejection

NCT ID NCT03656926

Completed 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.

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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

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