NCT01650545

Aerosol Liposomal Cyclosporine for Chronic Rejection in Lung Transplant Recipients

A Pilot Study to Demonstrate Efficacy and Safety of Aerosol Liposomal Cyclosporine (L-CsA) in the Treatment of Bronchiolitis Obliterans Syndrome After Lung Transplantation

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized single-center pilot study to investigate the efficacy and safety of aerosolized liposomal cyclosporine A (L-CsA) in the treatment of chronic rejection in lung transplant recipients with Grade 1 or 2 BOS. The primary endpoints will include: * Improvement or stabilization of pulmonary function test (FEV1) from baseline * Stabilization of histology (no deterioration from baseline) * Safety of the preparation The secondary endpoints will include: * Pharmacokinetics and distribution of CsA in blood - * Change in cytokine levels from BAL specimens.

Conditions

• Disorder Related to Lung Transplantation
• Bronchiolitis Obliterans
• Decreased Immunologic Activity
• Chronic Rejection of Lung Transplant

Interventions

Type	Name	Description
DRUG	Liposomal aerosol cyclosporine	inhaled form of immune suppression
OTHER	standard immune suppression, oral	conventional drug Conventrional oral immune suppression as standard of care thus consists of tacrolimus, mycophenolate mofetil prednisone and rapamycin

Timeline

• Start date: 2012-07-01
• Primary completion: 2015-08-01
• Completion: 2019-11-01
• First posted: 2012-07-26
• Last updated: 2023-06-01
• Results posted: 2017-10-25

Locations

1 site across 1 country: United States