Open-Label, Extension Trial to Demonstrate the Effectiveness and Safety of L-CsA Plus Standard of Care in the Treatment of BOS in Patients Post Single or Double Lung Transplant

• Status: Enrolling by invitation
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Enrollment will be limited to patients who have completed 48 weeks participation in either the BT-L-CsA-301-SLT (BOSTON-1) or BT-L-CsA-302-DLT (BOSTON-2) trial. All patients in this clinical trial will receive L-CsA in addition to Standard of Care, regardless of randomization arm in prior trials.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Breath Therapeutics Inc.; Zambon SpA
• Treatments: Cyclosporine; Cyclosporins

Criteria

Inclusion Criteria:

1. 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.

2. 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.

3. 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.

4. 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.

Exclusion Criteria:

1. Known hypersensitivity to L-CsA or to cyclosporine A.

2. Patients who experienced an AE related to study drug that led to permanent study drug discontinuation in BOSTON-1 or BOSTON-2.

3. 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.

4. Pregnant women or women who are unwilling to use appropriate birth control to avoid pregnancy through their End of Study Visit.

5. Women who are currently breastfeeding.

6. 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.

7. Patients who are currently participating in an interventional clinical trial, other than BOSTON-1 or BOSTON-2.

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

9. 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.