Aerosol Liposomal Cyclosporine for Chronic Rejection in Lung Transplant Recipients

University of Maryland, Baltimore21 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Treatment failure defined as: BOS progression (\> 20% decline lung function), re-transplant, or death

Time frame: approximately 1 year

Secondary Outcomes

Cytokine Analysis From BAL Fluid in Lung

Multiple cytokines were assessed as markers of lung inflammation that may be used in addition to biopsy data, collected per patient as clinically indicated during the follow-up interval. Values are reported as mean change from baseline in each group, per week

Time frame: baseline to approximately 1 year

Overall Survival at 5 Years Follow-up

Number of participants surviving at 5 year follow-up

Time frame: 5 years