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A Pilot Study to Demonstrate Efficacy and Safety of Aerosol Liposomal Cyclosporine (L-CsA) in the Treatment of Bronchiolitis Obliterans Syndrome After Lung Transplantation
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.
Details
| Lead sponsor | University of Maryland, Baltimore |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | COMPLETED |
| Enrolment | 21 |
| Start date | 2012-07 |
| Completion | 2019-11 |
Conditions
- Disorder Related to Lung Transplantation
- Bronchiolitis Obliterans
- Decreased Immunologic Activity
- Chronic Rejection of Lung Transplant
Interventions
- Liposomal aerosol cyclosporine
- standard immune suppression, oral
Primary outcomes
- Number Of Participants With Chronic Rejection Who Met Primary Combined End-point — approximately 1 year
Treatment failure defined as: BOS progression (\> 20% decline lung function), re-transplant, or death
Countries
United States