A Pilot Study to Demonstrate Efficacy and Safety of Aerosol Liposomal Cyclosporine (L-CsA) in the Treatment of Bronchiolitis Obliterans Syndrome After Lung Transplantation

HP-00049596

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.

2012-07-01

2015-08-01

2019-11-01

Completed

Early phase I

21

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open Label'}}, 'enrollmentInfo': {'count': 21, 'type': 'ACTUAL'}}

2023-06-01