Aerosol Cyclosporine for Prevention of Lung Rejection

Summary

To evaluate the efficacy of aerosolized cyclosporine given in addition to the standard oral immunosuppressive drug regimen, in preventing acute rejection immediately after lung transplantation

Timeline

Start

1998-04

Primary completion

—

Completion

2003-03

Outcome

Missed primary endpoint

paper The rates of acute rejection of grade 2 or higher were similar in the cyclosporine and placebo groups PMID 16407509 ↗

paper (P=0.87 by Poisson regression). PMID 16407509 ↗

Publications

• Background Burkart GJ, Smaldone GC, Eldon MA, Venkataramanan R, Dauber J, Zeevi A, McCurry K, McKaveney TP, Corcoran TE, Griffith BP, Iacono AT. Lung deposition and pharmacokinetics of cyclosporine after aerosolization in lung transplant patients. Pharm Res. 2003 Feb;20(2):252-6. doi: 10.1023/a:1022275222207.
• Results 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

Evaluation	Drug	Modality	Dose	Route
Subject	Cyclosporine	Peptide	300 mg	Inhaled
Background	Azathioprine	Small molecule	—	Oral
Background	Prednisone	Other / unclassified	—	Oral
Background	Tacrolimus	Small molecule	—	Oral

Indications