A Pilot Study to Demonstrate Efficacy and Safety of Aerosol Liposomal Cyclosporine (L-CsA) in the Treatment of Bronchiolitis Obliterans Syndrome After Lung Transplantation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Number Of Participants With Chronic Rejection Who Met Primary Combined End-point
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open Label
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic rejection
- •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
排除标准
- 未提供
研究组 & 干预措施
Liposomal Aerosol Cyclosporine
Arm 1) Aerosol liposomal cyclosporine Open label randomized trial using experimental inhalational therapy with liposomal aerosol cyclosporine in addition to standard immune suppression (tacrolimus , mycophenolate mofetil and prednisone) for 6 month duration at inhalational doses (5mg and 10 mg bid), to be defined by transplant type respectively (single, double lung transplant )
干预措施: Liposomal aerosol cyclosporine (Drug)
Liposomal Aerosol Cyclosporine
Arm 1) Aerosol liposomal cyclosporine Open label randomized trial using experimental inhalational therapy with liposomal aerosol cyclosporine in addition to standard immune suppression (tacrolimus , mycophenolate mofetil and prednisone) for 6 month duration at inhalational doses (5mg and 10 mg bid), to be defined by transplant type respectively (single, double lung transplant )
干预措施: standard immune suppression, oral (Other)
Conventional oral immune suppression
Arm 2) Standard immune suppression consisting of typical oral immune suppression for lung transplant recipients typically tacrolimus, mycophenolate mofetil and prednisone.
Conventrional oral immune suppression as standard of care thus consists of tacrolimus, mycophenolate mofetil prednisone rapamycin described in the subsequent section as well.
干预措施: standard immune suppression, oral (Other)
结局指标
主要结局
Number Of Participants With Chronic Rejection Who Met Primary Combined End-point
时间窗: approximately 1 year
Treatment failure defined as: BOS progression (\> 20% decline lung function), re-transplant, or death
次要结局
- Cytokine Analysis From BAL Fluid in Lung(baseline to approximately 1 year)
- Overall Survival at 5 Years Follow-up(5 years)