Extracorporeal Photopheresis in Patients With Bronchiolitis Obliterans Syndrome (BOS) After Lung Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- FEV1 stabilisation
研究概览
简要总结
Investigation of photopheresis as new therapy regimen in patients with bronchiolitis obliterans syndrome after lung transplantation in a controlled, randomized study
详细描述
Bronchiolitis obliterans syndrome is the major cause of mortality after lung transplantation. 5 years after lung transplantation about 50% of all patients have this syndrome. There are nearly none therapy options. Besides effective therapy of any gastrooesophageal reflux and an oral medication with azithromycin none further regimens are known. Photopheresis could show in several studies a benefit for patients with gvhd after bone marrow transplantation or for chronic rejection after any other solid organ transplantation. Just little case reports could show beneficial effect in patients with bos after lung transplantation.
This is the first controlled, randomized study with patients with bos after lung transplantation to investigate the effectiveness of this therapy in that patients.
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
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Single/Double lung transplantation
- •at least 6 months after lung transplantation
- •bronchiolitis obliterans syndrome, Stadium > 1 (nach ISHLT 2001, FEV1 <80% Best), none other reason for worsening lung function (eg acute rejection, infection, extrapulmonary reasons, airway obstruction)
- •none gastroesophageal reflux
- •medication for > 3 months with Azithromycin with further decrease of FEV1, MEF 25-75
- •bioptic prove that there is no acute rejection
- •no improvement under steroid pulse therapy
排除标准
- •tumor or hematologic disease
- •acute rejection
- •respiratory insufficiency (O2>2l/min, pCO2 >50 mm Hg)
- •weight < 40 kg
- •acute infection
- •colonization with multiresistant pathogens
研究组 & 干预措施
1
Observation with standard care (macrolides, exercise, oxygen therapy etc.) alone.
干预措施: photopheresis (Procedure)
2
2-day cycles of photopheresis every 3 weeks for 3 months
干预措施: photopheresis (Procedure)
结局指标
主要结局
FEV1 stabilisation
时间窗: 6 month
次要结局
未报告次要终点