Liposomal Cyclosporine A for Bronchiolitis Obliterans Syndrome
(BOSTON-1 Trial)

Recruiting in Palo Alto (17 mi)

+44 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Zambon SpA

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The objective of the trial is to assess efficacy and safety of add-on aerosolized liposomal cyclosporine A (L-CsA) to Standard of Care (SoC) therapy as compared to SoC therapy alone in the treatment of Bronchiolitis obliterans syndrome (BOS) in single lung transplant recipients.

Research Team

Paola Castellani, MD

Principal Investigator

Zambon SpA, Chief Medical Officer

Eligibility Criteria

This trial is for adults over 18 who had a single lung transplant at least a year ago and are diagnosed with Bronchiolitis Obliterans Syndrome (BOS). They must have stable immunosuppressive therapy, understand the study, consent to data retrieval, not be pregnant or breastfeeding, use contraception if applicable, and not have any life-threatening conditions expected within a year.

Inclusion Criteria

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. Patients must consent to retrieve prespecified data from the historic medical record (e.g., information related to the transplant surgery; spirometry data; medication use)

I am over 18 and had a lung transplant more than a year ago.

I was diagnosed with CLAD-BOS over a year after my lung transplant and have shown a decline in lung function.

See 5 more

Exclusion Criteria

My lung function loss is confirmed to be due to a specific cause other than cancer.

My liver function tests are not more than 3 times the normal range.

Women who are currently breastfeeding

See 15 more

Treatment Details

Interventions

Liposomal Cyclosporine A (Immunosuppressant)
Standard of Care (Drug)

Trial OverviewThe trial tests aerosolized liposomal cyclosporine A added to standard care versus standard care alone in treating BOS after lung transplantation. The goal is to see if this new treatment improves lung function and patient outcomes compared to usual treatments.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: L-CsA treatment plus SoCExperimental Treatment1 Intervention

Liposomal Cyclosporine A 5 mg twice daily for 48 weeks + Standard of Care Therapy

Group II: Control treatmentActive Control1 Intervention

In this arm only the standard of care is administered. Standard of care is a maintenance regimen of immunosuppressive agents.