Identification of Serum Biomarkers for CD15+ Hypodense Neutrophils in Severe Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percentage of low density granulocytes (LDG) in the peripheral blood mononuclear cell (PBMC)
研究概览
简要总结
The goal of this study is to identify a serum biomarker(s) that can detect increased levels of a population of CD15+ hypodense neutrophils termed low-density granulocytes (LDG) in the blood of patients with severe persistent asthma.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Percentage of low density granulocytes (LDG) in the peripheral blood mononuclear cell (PBMC)
时间窗: Visit 1 day
mRNA levels in severe asthmatics as analyzed by gene profiling analysis
时间窗: Visit 1 day
Messenger ribonucleic acid (mRNA) expression levels for blood leukocyte proteins.
次要结局
- Number of Participants with elevated LDG levels in severe asthmatics using gene profiling analysis on a single PAXgene tube sample(Visit 1 day)
- Serum samples will be collected and analyzed for measurement of total IgE(Visit 1 day)
研究者
Mary Tobin
Director
Rush University Medical Center