Aerosol Liposomal Cyclosporine for Chronic Rejection in Lung Transplant Recipients

Summary

This is a single-center pilot study to investigate the efficacy and safety of aerosolized liposomal cyclosporine A in the treatment of chronic rejection in lung transplant recipients with bronchiolitis obliterans syndrome (BOS). The primary objective is to evaluate the efficacy of liposomal cyclosporine A in the treatment of chronic rejection. Pulmonary function and changes in BOS grade are the primary end points.

Timeline

Start

2012-07

Primary completion

2015-08

Completion

2019-11

Outcome

Met primary endpoint

registry analysis (superiority test); Liposomal Aerosol Cyclosporine vs Conventional Oral Immune Suppression; p = 0.03; Log Rank NCT01650545 ↗

Publications

• Background Iacono AT, Johnson BA, Grgurich WF, Youssef JG, Corcoran TE, Seiler DA, Dauber JH, Smaldone GC, Zeevi A, Yousem SA, Fung JJ, Burckart GJ, McCurry KR, Griffith BP. A randomized trial of inhaled cyclosporine in lung-transplant recipients. N Engl J Med. 2006 Jan 12;354(2):141-50. doi: 10.1056/NEJMoa043204.

Drugs

Indications