NCT01241890已完成不适用
Prevention of CF Exacerbation in Childhood (PREVEC): Early Recognition of Inflammation by Non-invasive Biomarkers in Exhaled Breath (Condensate)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 3
- 主要终点
- Number of exacerbations
研究概览
简要总结
Pulmonary exacerbations of CF are an important cause for the experienced disability of patients, respiratory symptoms, and decreases in lungfunction, which require antibiotic therapy at home or in the hospital. Therefore, prevention of exacerbations in CF is important. The aim of this study was to assess the predictive properties of inflammatory markers in exhaled breath for pulmonary exacerbations in children with CF. In addition the reliability of home monitor assessments of symptoms and lungfunction was investigated.
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
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CF disease is defined as the combination of:
- •characteristic clinical features (persistent pulmonary symptoms, meconium ileus, failure to thrive, steatorrhoea);
- •and/or abnormal sweat test (Chloride > 60mM);
- •and/or two CF mutations.
排除标准
- •cardiac abnormalities;
- •mental retardation;
- •no technical satisfactory performance of measurements;
- •on the waiting list for lung transplantation;
- •non-compliance with the home-assessments;
- •patients with Burkholderia Cepacia;
- •participation in another intervention trial.
结局指标
主要结局
Number of exacerbations
时间窗: 1 year
Definition of an exacerbation according to Treggiari MM et al.
次要结局
- Quality of life(1 year)
研究者
研究点 (3)
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