Mechanism of Action of Fluticasone Furoate in Childhood Obstructive Sleep Apnea Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of CD25 Pos/FoxP3 Positive Cells
研究概览
简要总结
The purpose of this research is to find out how a nasal spray (fluticasone furoate), sometimes given to children with obstructive sleep apnea syndrome (OSAS), works on certain cells within a child's adenoids. We hypothesize that intranasal steroids lead to an upregulation of T regulatory cells in the adenoid tissues of children with OSAS. This will result in a local reduction in inflammation and edema explaining the improvement in OSAS.
详细描述
The objective was to determine the effect of intranasal corticosteroid therapy on T-regulatory cells and other inflammatory cytokines in adenoid tissues in children with obstructive sleep apnea syndrome.Children were randomized to either no treatment or treatment with fluticasone furoate nasal spray, 55 μg/nostril daily, for 2 weeks before adenotonsillectomy. Adenoid tissue was obtained at the time of the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: between 2 and 12 years
- •Polysomnogram results showing AHI >5/hr irrespective of saturations
- •No other significant medical problems except well controlled asthma
- •No chronic medication intake except bronchodilators and leukotriene receptor antagonists
- •No systemic steroids within the past month
- •No intranasal steroids within the past 2 weeks
排除标准
- •Patients with OSAS who are overweight (BMI>95th percentile for age) or who have neurological or craniofacial abnormalities as these tend to have OSAS related to these factors per se.
- •Females of the specified age group who have already had their first period.
研究组 & 干预措施
Fluticasone furoate
55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy
干预措施: fluticasone furoate (Drug)
结局指标
主要结局
Number of CD25 Pos/FoxP3 Positive Cells
时间窗: following adenoidectomy (2 weeks)
The number of tissue T-regulatory cells, as determined by staining with FOXP3, CD4, and CD25
Number of CD4 Pos/FOXP3 Positive Cells
时间窗: following adenoidectomy (2 weeks)
The number of tissue T-regulatory cells, as determined by staining with FOXP3, CD4, and CD25
IL-10 Staining Intensity
时间窗: following adenoidectomy (2 weeks)
IL-10 staining intensity on immunohistochemical staining of adenoid tissues. Units are Integrated optical density (IOD)/100 micrometer squared.
Amount of IL-10 Secreted by Adenoid Cells After PHA Stimulation
时间窗: following adenoidectomy (2 weeks)
Amount of IL-10 secreted by adenoid cells after PHA stimulation
Amount of TGF Secreted by Adenoid Cells After PHA Stimulation
时间窗: following adenoidectomy (2 weeks)
Amount of TGF secreted by adenoid cells after PHA stimulation
次要结局
- Adjusted Volume of the Removed Adenoids(following adenoidectomy (2 weeks))