CompletedPhase 1/2

Aerosol Liposomal Cyclosporine for Chronic Rejection in Lung Transplant Recipients

United States21 participantsStarted 2012-07

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Bronchiolitis obliterans diagnosed by bronchiolitis obliterans syndrome and \> 20% decline from the individual patient's best FEV1 is observed
✓. Recipient of a double or single lung transplant
✓. Receiving immunosuppressive treatment according to institutional standards

Exclusion criteria

✕. Active invasive bacterial, viral or fungal infection
✕. Current mechanical ventilation
✕. Pregnant or breast-feeding woman
✕. Known hypersensitivity to cyclosporine A
✕. Serum creatinine value of more than 265 μmol/L (3 mg/dL) or chronic dialysis
✕. Receipt of an investigational drug as part of a clinical trial

What they're measuring

Number Of Participants With Chronic Rejection Who Met Primary Combined End-point

Timeframe: approximately 1 year

Trial details

NCT IDNCT01650545

SponsorUniversity of Maryland, Baltimore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-08

Results submitted2017-10-24

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