Role of Circulating Innate Lymphoid Cells in Allergic Disorders
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- ILC2 Phenotype
研究概览
简要总结
This study evaluates blood type 2 innate lymphoid cells in participants with mild to moderate asthma and participants with chronic urticaria as compared to healthy adult participants.
详细描述
The first objective of this study is to determine whether blood ILC2s differ in female vs. male allergic asthmatics. This is because females become more susceptible to asthma after puberty and experience more severe disease as adults.
The second objective of this study is to determine whether ILC2 cells in chronic urticaria differ from healthy controls.
There will be one shared healthy control adult subject group for comparison for objective 1 and 2.
In this study, there will be a blood draw once on 3 different adult populations aged 19-50 years: 1) Participants with mild-to moderate allergic asthma; 2) Participants with chronic urticaria, and 3) Healthy control adult participants. Demographics and allergy indicators will be collected from the medical chart. The investigators will acquire whole blood for serum and acquisition of specific lymphocyte populations. There will be no intervention or research follow up.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult subjects between age 19-50 years.
- •Non-smokers, defined as < 100 cigarettes in lifetime.
排除标准
- •Female donors will be excluded if they are menopausal or have undergone total abdominal hysterectomy and/or bilateral salpingoophorectomy
- •For female donors, blood draw cannot occur during menstrual period time. Subjects will be excluded if they have menstrual period at timing of blood draw.
- •Current and past smokers.
- •Subjects with asthma and any other lung disease including chronic obstructive pulmonary disease, interstitial lung disease, pulmonary hypertension, sarcoidosis, cystic fibrosis.
- •Pregnant or lactating subjects
- •Subjects with hypercalcemia (> 10.3 mg/dL), renal insufficiency (glomerular filtration rate [GFR] < 50 mL/min/1.73m2), or malignancy.
- •Subjects with any symptoms of respiratory infection in the past 4 weeks.
- •Subjects unable to hold leukotriene modifiers or antihistamines for at least 24 hours prior to blood draw.
- •Subjects on any immunomodulators, including omalizumab, or systemic corticosteroid in the past 4 weeks.
结局指标
主要结局
ILC2 Phenotype
时间窗: 52 weeks
Blood ILC2s responsiveness will be determined solely for research purposes using ex vivo stimulation assays.
次要结局
未报告次要终点