NCT01239238已完成不适用
Reduction of Asthma Exacerbation Rate in Children by Non-invasive Monitoring of Inflammatory Markers in Exhaled Breath (Condensate): the RASTER Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- number of exacerbations
研究概览
简要总结
The purpose of the present proposal was to investigate the predictive properties of markers in exhaled breath to predict an asthma exacerbation. In addition, the reliability of home monitor assessments to measure asthma control will be examined.
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 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •already known with a diagnosis of asthma during at least 6 months
- •age between 6 and 17 years
- •reversibility to a bronchodilator (increase in FEV1 > 9% of predicted value and/or
- •bronchial hyperresponsiveness to histamine < 8 mg/ml.
排除标准
- •cardiac abnormalities
- •mental retardation, congenital abnormalities or existence of a syndrome
- •active smoking
- •no technical satisfactory performance of measurements
- •no phone line or internet assess available at home.
结局指标
主要结局
number of exacerbations
时间窗: 1 year
increase of asthma symptoms, use of short b2-agonists, drop in FEV1% of maximum personal value.
asthma control
时间窗: 1 year
asthma control questionnaire
Quality of life
时间窗: 1 year
Asthma Quality of Life questionnaire for children
次要结局
- cost-effectiveness(1 year)
研究者
研究点 (2)
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