跳至主要内容
临床试验/NCT00888472
NCT00888472已完成不适用

Safety and Efficacy of High-dose Leukocytapheresis Using a Large Filter in Patients With Refractory Asthma

Gunma University2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2008年11月最近更新:
适应症
干预措施

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

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tamotsu Ishizuka

Clinical Professor

Gunma University

研究点 (2)

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