jRCT1031230460招募中不适用
Comprehensive analysis of eosinophils and type 2 innate lymphoid cells in patients with severe asthma before and after mepolizumab treatment (MEISEA)
未提供0 个研究点目标入组 40 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 主要终点
- specific cellular changes of eosinophils and ILC2s
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Other
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Basic Science
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 80age old under(—)
- 性别
- All
入选标准
- •Patients with severe eosinophilic asthma that is defined as blood eosinophil counts >=150 cells/mm3 at enrollment and/or blood eosinophil counts >=300 cells/mm3 before the study (from the date at diagnosis of asthma to the enrollment date of this study) will be included in this study. They meet all of the following criteria.
- •The therapeutic management using high-dose ICS (Fluticasone propionate equivalent to >=1000 microgram/day or fluticasone furan carboxylic acid equivalent to >= 200 microgram/day) and >= 2 long-term management medicines (LABA, leukotriene receptor antagonist, theophylline, or LAMA).
- •Male and female between 18 and 80 years of age inclusive
- •<150 kg at weight.
- •The patient has provided written informed consent
- •Healthy volunteers will be included in this study. They meet all of the following criteria.
- •The one has no history of specific diseases.
- •Male and female between 18 and 80 years of age inclusive
- •<150 kg at weight.
- •The patient has provided written informed consent
排除标准
- •Patients are NOT eligible for this study if they met any of the following criteria:
- •Has previously been treated with mepolizumab before the study
- •Has a history of acute viral infection up to 4 weeks prior to blood sampling
- •Has been treated with systemic corticosteroids including methylprednisolone up to 4 weeks prior to blood sampling
- •History of widespread lung disease
- •Has cancer/malignancy under treatment
- •During the period of pregnancy
- •Individuals whom the principal investigators judge as inappropriate registers
- •Healthy volunteers are NOT eligible for this study if they met any of the following criteria:
- •Has a history of acute viral infection up to 4 weeks prior to blood sampling
- •Individuals whom the principal investigators judge as inappropriate registers
结局指标
主要结局
specific cellular changes of eosinophils and ILC2s
Identify specific cellular changes of eosinophils and ILC2s and their benefit to predict mepolizumab treatment responsiveness.
次要结局
- molecular differences and similarities of eosinophils and ILC2s
研究者
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