Redox Determinants of Severe Asthma: A Substudy of the NHLBI Severe Asthma Research Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Exhaled Nitric Oxide at Baseline and Over the Observational Period
研究概览
简要总结
Hypotheses: 1) Airway pH regulation is abnormal in severe asthma; 2) In severe asthma, there is formation of cytotoxic nitrogen oxides and loss of beneficial nitrogen oxides in the airways
详细描述
Specific Aim 1:Test hypothesis that airway pH regulation is abnormal in severe asthma.
1a) Determine the effects of systemic corticosteroids on breath pH in children with severe and mild to moderate asthma.
1b) Examine whether breath condensate pH and other biomarkers of oxidant stress can predict clinical outcomes in children with severe and mild to moderate asthma.
1c) Identify whether increased Th1/Th2 cytokine ratio, and abnormalities in airway glutaminase, G-SNO-reductase, VATPase, and carbonic anhydrase are associated with airway pH disturbance in children with severe asthma.
1d) Test whether rhinovirus infections, which reduce airway pH, persist longer or are more frequent in children with severe asthma than in children with mild to moderate asthma.
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
- 6 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 6 years old
- •Asthma diagnosis by physician
- •Current treatment with an inhaled corticosteroid medication
- •Exclusion criteria:
- •Bronchiectasis
- •Cystic Fibrosis
- •Chronic Obstructive Pulmonary Disease
排除标准
- 未提供
结局指标
主要结局
Exhaled Nitric Oxide at Baseline and Over the Observational Period
时间窗: baseline and after 21 days
Exhaled nitric oxide concentrations as measured by collection of exhaled breath into a mylar bag
次要结局
- Reduction in Breath pH(baseline and 21 days)
研究者
Anne M Fitzpatrick PhD
Assistant Professor
Emory University