Liposomal Cyclosporine A for Lung Transplant Rejection
(BOSTON-2 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 double lung transplant recipients.

Research Team

Paola Castellani, MD

Principal Investigator

Zambon SpA, Chief Medical Officer

Eligibility Criteria

Adults over 18 who had a double lung transplant at least a year ago and are diagnosed with Bronchiolitis Obliterans Syndrome (BOS). They must have specific lung function levels, be on stable immunosuppressive drugs, and not have certain infections or cancers. Pregnant women, those with severe liver or kidney issues, uncontrolled hypertension, or recent participation in other trials cannot join.

Inclusion Criteria

I received a double lung transplant more than a year ago.

My treatment plan hasn't changed in the last 4 weeks.

I was diagnosed with CLAD-BOS 1-12 months ago or showed a decline in lung function not due to infection or rejection.

See 12 more

Exclusion Criteria

Women who are currently breastfeeding

Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary procedures

I have liver disease with abnormal liver function tests.

See 16 more

Treatment Details

Interventions

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

Trial OverviewThe trial is testing if adding aerosolized liposomal cyclosporine A to the usual care for BOS after a double lung transplant is safe and works better than the usual care alone. Participants will either receive this new treatment or stick to their standard regimen.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: L-CsA treatment plus SoCExperimental Treatment1 Intervention

Liposomal Cyclosporine A (L-CsA) 10 mg twice daily for 48 weeks, plus Standard of Care Therapy

Group II: Standard of CareActive Control1 Intervention

This is a maintenance regimen of immunosuppressive agents