Aerosol Liposomal Cyclosporine for Chronic Rejection in Lung Transplant Recipients

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.

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