L-CsA + Standard of Care for Bronchiolitis Obliterans Syndrome
(BOSTON-3 Trial)

Recruiting in Palo Alto (17 mi)

+49 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 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.

Eligibility Criteria

This trial is for post lung transplant patients with Bronchiolitis Obliterans Syndrome (BOS) who are on a three-drug immunosuppressive regimen. They must have completed prior BOSTON trials without early termination or consent withdrawal, not be pregnant or breastfeeding, agree to use contraception, and have no new cancers except certain skin carcinomas.

Inclusion Criteria

I am on a 3-drug regimen including tacrolimus (or similar), MMF/azathioprine, and a steroid.

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.

I understand the trial's risks, have given consent, can follow the schedule, and can inhale aerosols.

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Exclusion Criteria

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.

I have not taken any experimental drugs, except L-CsA, in the last 4 weeks.

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Treatment Details

Interventions

Liposomal Cyclosporine A 10 mg (Immunosuppressant)
Liposomal Cyclosporine A 5 mg (Immunosuppressant)

Trial OverviewThe study aims to evaluate the long-term safety and effectiveness of Liposomal Cyclosporine A (L-CsA) at two different doses added to Standard of Care in treating BOS after single or double lung transplants.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: L-CsA 5 mg plus Standard of CareExperimental Treatment1 Intervention

L-CsA 5 mg twice daily plus Standard of Care for up to 144 weeks for patients post Single Lung Transplant

Group II: L-CsA 10 mg plus Standard of CareExperimental Treatment1 Intervention

L-CsA 10 mg twice daily plus Standard of Care for up to 144 weeks for patients post Double Lung Transplant