Safety and Efficacy of High-dose Leukocytapheresis Using a Large Filter in Patients With Refractory Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Improvement of morning peak flow rate (PEFR) or evening PEFR
研究概览
简要总结
Extracorporeal leukocytapheresis (LCAP) or granulocytapheresis (GCAP) has been used in the treatment of patients with rheumatoid arthritis and ulcerative colitis and has shown promising safety and efficacy. LCAP and GCAP seem to be effective for steroid-resistant inflammation. The investigators have already reported safety and efficacy of GCAP in refractory asthma and expect the beneficial effect of LCAP in refractory asthma. In this study, in order to improve the therapeutic effect of LCAP by increasing the quantity of leukocytes that were removed, the investigators conducted a clinical study to investigate safety and efficacy of high-dose LCAP performed using a larger filter and an increased dose of the blood volume per body weight treated, as an possible therapy for refractory asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients fulfilled the 2001 criteria for refractory asthma in American Thoracic Society.
排除标准
- •Pregnant women.
- •Patients with severe cardiovascular diseases.
- •Patients with infective diseases.
- •Patients with leukocytopenia or anemia.
研究组 & 干预措施
1
干预措施: Leukocytapheresis (Procedure)
结局指标
主要结局
Improvement of morning peak flow rate (PEFR) or evening PEFR
时间窗: 4 weeks after the treatment
次要结局
- An improved score of asthma control test(4 weeks after the treatment)
研究者
Tamotsu Ishizuka
Clinical Professor
Gunma University
