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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01650545
Study type Interventional
Source University of Maryland, Baltimore
Contact
Status Completed
Phase Phase 1/Phase 2
Start date July 2012
Completion date November 2019

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