Ignite Creation Date:
2024-05-06 @ 12:45 AM
Last Modification Date:
2024-10-26 @ 10:54 AM
Study NCT ID:
NCT01650545
Status:
COMPLETED
Last Update Posted:
2023-06-01
First Post:
2012-06-27
Brief Title:
Aerosol Liposomal Cyclosporine for Chronic Rejection in Lung Transplant Recipients
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
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
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None