IVIG Treatment for Asthmatic Patients With IgG Subclass Deficiency
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 30
- 主要终点
- Infection rate
研究概览
简要总结
Immunoglobulin G deficiency subtypes in patients with asthma six months once a month intravenous immunoglobulin (400mg/kg/4weeks) infection in treatment-related effect on reducing the frequency of asthma exacerbations appreciate.
详细描述
Patients Registration
•It is required to ensure that the patients meet the inclusion criteria for this clinical trial, are free from any items of exclusion criteria, are explained about the participation in the clinical trial along with the informed consent forms.
Procedure
•six months once a month intravenous immunoglobulin (400mg/kg/4weeks)
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
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient from over 16 years to under 75 years
- •Patients diagnosed with asthma over six months ago
- •immunoglobulin G subtypes who were diagnosed with immune deficiency
- •more than 2 years Upper and lower respiratory tract infections
- •, and asthma exacerbations in this regard.
- •① calculated creatinine clearance ≧ 50ml/min
- •ALT and AST <x 3 times the upper limit of normal
- •ALP <x 3 times the upper limit of normal
- •total bilirubin <x 1.5 times the upper limit of normal
排除标准
- •within six months of the onset of the experiment who received immunoglobulin therapy
- •immune globulin for those with a history of hypersensitivity reactions
- •six months ago, another clinical trial participants.
- •Systemic steroids and immunomodulators, such as asthma control that may affect the resources required drug administration.
- •pregnant or lactating women.
研究组 & 干预措施
Immune Globulin
Immunoglobulin G Deficiency Associated with persistent asthma subtypes
干预措施: Immune Globulin (Drug)
结局指标
主要结局
Infection rate
时间窗: 6months
6 months after treatment compared to before treatment 6 months
次要结局
- adverse events(6months)
- lung funtion(6 months)
- Questionnair(6months)
- steroid(6 months af)
- IgG subclass(6months)
- asthma syptoms(6months)
- Questionnaire(6months)
- Cytokines(6months)
- antibiotic(6months)
研究者
Hae-Sim Park
Professor, Department of medicine, Ajou University School of Medicine
Ajou University School of Medicine