NCT01002313已完成不适用
Effect of Prednisone on Peripheral Blood T-cell Function (Tregs and Th17) in Patients With Chronic Rhinosinusitis (CRS)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Treg cell numbers
研究概览
简要总结
The primary objective of this study is to see whether systemic corticosteroids (such as Prednisone) have an effect on the peripheral blood Treg and Th17 function in patients with CRS. Patients are taking prednisone as part of their routine medical care.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of CRS.
- •A CT scan performed in the last year depicting the severity of the disease or nasal polyps on endoscopy.
- •Symptomatic at the time of entry into the study as determined by scores ≥ 1.4 on the Rhinosinusitis disability index
排除标准
- •Women who are pregnant or breastfeeding.
- •Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (heart, lung, kidney, diabetes, osteoporosis, cataracts, glaucoma, neurological, oncologic, liver disease or a contraindication to taking prednisone).
- •Use of any other investigational agent in the last 30 days.
- •Use of clinical drugs like antihistamines, leukotriene modifiers, intranasal steroids, systemic corticosteroids in the last 15 days or immunotherapy in the last year.
- •Upper respiratory infection within 14 days of study start
- •Smoking within the last 2 months.
结局指标
主要结局
Treg cell numbers
时间窗: pre treatment vs post treatment
次要结局
- Cytokine levels in cultured PBMCs(pre vs post treatment)
研究者
研究点 (1)
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