Extension Trial on Efficacy / Safety of L-CsA + SoC in Treating BOS in Post Single or Double Lung Transplant (BOSTON-3)

Stopped early · Phase 3

Conditions studied: Bronchiolitis Obliterans, Obliterative Bronchiolitis, Bronchiolitis Obliterans Syndrome

In brief

The objective of the trial is to assess the long-term safety and efficacy of L-CsA plus Standard of Care (SoC) in the treatment of BOS in single (SLT) and double lung transplant (DLT) recipients.

Key facts

Study ID

NCT04039347

Run by

Zambon SpA

People needed

164

Starts

2020-03-12

Expected to finish

2026-02-25

Last updated by the study team

2026-04-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.
• 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.
• 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.

You may not qualify if…

• Known hypersensitivity to L-CsA or to cyclosporine A.
• Patients who experienced an AE related to study drug that led to permanent study drug discontinuation in BOSTON-1 or BOSTON-2.
• 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.
• Pregnant women or women who are unwilling to use appropriate birth control to avoid pregnancy through their End of Study Visit.
• Women who are currently breastfeeding.
• 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.
• Patients who are currently participating in an interventional clinical trial, other than BOSTON-1 or BOSTON-2.
• Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary procedures.
• 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.

Where it is running

• Banner - University Medical Center — Phoenix, Arizona, United States
• David Geffen School of Medicine at UCLA — Los Angeles, California, United States
• UCSF — San Francisco, California, United States
• UCSF Center for Advanced Lung Disease — Stanford, California, United States
• University of Florida Dept of Pulmonary Medicine — Gainesville, Florida, United States
• Indiana University — Indianapolis, Indiana, United States
• UK Albert B. Chandler Hospital — Lexington, Kentucky, United States
• University of Maryland — Baltimore, Maryland, United States
• Johns Hopkins University Hospital — Baltimore, Maryland, United States
• Barnes-Jewish Hospital — St Louis, Missouri, United States
• Columbia University Medical Center — New York, New York, United States
• Duke University — Durham, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• OSU Wexner Medical Center — Columbus, Ohio, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Baylor University Medical Center — Dallas, Texas, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• Houston Methodist Hospital — Houston, Texas, United States
• Waehringer Guertel — Vienna, Austria
• Hôpital Erasme — Brussels, Belgium
• Universitair Ziekenhuis Leuven — Leuven, Belgium
• Copenhagen University Hospital — Copenhagen, Denmark
• Hopital Marie Lannelongue — Le Plessis-Robinson, France

Full record on ClinicalTrials.gov

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