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Keep this study
Lead
University of Maryland, Baltimore
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
