Identification of Serum Biomarkers for CD15+ Hypodense Neutrophils in Severe Asthma
研究概览
地位
条件
详细说明
Neutrophils are implicated in the pathophysiology of multiple asthma phenotypes. It was shown in study IST Q4935s that low-density granulocytes (LDG) are elevated in the blood of patients with moderate or severe asthma. The greatest frequency and the highest percentages of LDG were observed in subjects with severe asthma. The LDG, which were first identified and characterized in systemic lupus erythematosus (SLE) patients, have been reported to display increased cytotoxicity for endothelial cells, increased tendency to form neutrophil extracellular traps, and increased production of tumor necrosis factor (TNF). It was also observed that the LDG expressed increased levels of CD15, which can facilitate attachment of activated platelets to the LDG. Identification of a putative serum biomarker that correlates with increased levels of the CD15+ LDG may be useful for the detection of neutrophil-associated inflammation in severe asthma.
Thirty subjects will be screened to identify 20 subjects with severe persistent asthma. The following data and/or samples will then be obtained within three weeks of the clinical assessment: (1) the percentages of LDG will be quantified by flow cytometry; (2) a blood sample will be collected into a PAXgene Blood tube and stored until shipped to Genentech for gene profiling analysis; and (3) a serum sample will be collected for measurement of total immunoglobulin E (IgE) and for future confirmation of potential biomarkers identified in the gene profiling analyses.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Illinois
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Chicago、Illinois、美国、60612
- University Consultants in Allergy/Immunology
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Physician diagnosis of severe persistent asthma;
- Positive skin test or radioallergosorbent test (RAST) for an aeroallergen;
- Male or female age 12-65 years;
- Non-smoker.
Exclusion Criteria:
- Asthma exacerbation requiring treatment with or increase in oral corticosteroids within 30 days prior to the study;
- Respiratory infection within 30 days prior to the study;
- Starting or requiring a change in allergen immunotherapy within 30 days prior to the study;
- Having been treated with Xolair within the past year;
- Requiring chronic immunosuppressive therapy;
- Having taken methotrexate, gold salts, cyclosporine, or macrolide antibiotics within 3 months prior to study;
- Having taken an investigational drug within 30 days prior to the study;
- Have a history of drug or alcohol abuse;
- Pregnancy
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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Severe Persistent Asthma
All subjects will have severe persistent asthma diagnosed by a doctor.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Percentage of low density granulocytes (LDG) in the peripheral blood mononuclear cell (PBMC)
大体时间:Visit 1 day
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Visit 1 day
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mRNA levels in severe asthmatics as analyzed by gene profiling analysis
大体时间:Visit 1 day
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Messenger ribonucleic acid (mRNA) expression levels for blood leukocyte proteins.
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Visit 1 day
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Number of Participants with elevated LDG levels in severe asthmatics using gene profiling analysis on a single PAXgene tube sample
大体时间:Visit 1 day
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Visit 1 day
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Serum samples will be collected and analyzed for measurement of total IgE
大体时间:Visit 1 day
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Correlation between LDG in severe asthma and biomarkers identified in gene profiling analysis
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Visit 1 day
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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