Aerosol Liposomal Cyclosporine for Chronic Rejection in Lung Transplant Recipients

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland; University of Maryland, College Park
• Treatments: Cyclosporine; Cyclosporins; Sirolimus; Tacrolimus

Criteria

Inclusion Criteria:

Chronic rejection

1. Bronchiolitis obliterans diagnosed by bronchiolitis obliterans syndrome and > 20% decline from the individual patient's best FEV1 is observed

2. Recipient of a double or single lung transplant

3. Receiving immunosuppressive treatment according to institutional standards

Exclusion criteria:

1. Active invasive bacterial, viral or fungal infection

2. Current mechanical ventilation

3. Pregnant or breast-feeding woman

4. Known hypersensitivity to cyclosporine A

5. Serum creatinine value of more than 265 μmol/L (3 mg/dL) or chronic dialysis

6. Receipt of an investigational drug as part of a clinical trial