Clinical Trials

Inclusion Criteria:

• 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 maintenance regimen of immunosuppressive agents as defined in the Boston 1 and Boston 2 studies (i.e., tacrolimus, a second agent such as but not limited to mycophenolate mofetil (MMF) or azathioprine, and a systemic corticosteroid such as prednisone as third agent. Concomitant azithromycin for prophylaxis or treatment of BOS is also allowed) or according to Investigator judgment.
• 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.

Exclusion Criteria:

• 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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 12/11/23. Questions regarding updates should be directed to the study team contact.