Assessment of Utility of Exhaled Nitric Oxide Measurement for Treatment Monitoring in Children With Asthma
试验速览
- 阶段
- 4 期
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Control of the disease
研究概览
简要总结
The aim of this study is to assess the utility of exhaled nitric oxide measurement (FeNO) in treatment monitoring in children with asthma.
According to the aim of the study following assumptions are formulated:
- Comparison of annual cumulative steroid dose, number of bronchodilator doses taken, number of asthma exacerbation, number of hospitalisation due to asthma, between group of children with asthma with FeNO monitored treatment (study group), and group of children with treatment monitored by GINA's grade of disease clinical control (control group)
- Assessment of corelation of FeNO (ppb) with symptom score (points)and lung function (FEV1)
- Comparison of values of non-specific bronchial hyperresponsiveness with methacholine (PC20M)between both study groups after 12. months of treatment.
详细描述
Asthma is one of the most common chronic disease worldwide, imposing a substantial social burden on both children and adults.
What needs to be kept in mind, especially in assessing treatment effect of allergic inflammation in children with asthma, is that symptom score and spirometry measures have limitations, mainly their subjectivity (symptom scores), wide variability, and lack of stability in short time period (symptom scores and spirometry measures).
Monitoring allergic inflammation in the course of asthma in children with exhaled nitric oxide measurement (FeNO) may allow to titrate the dose of inhaled glucocorticosteroids more precisely, depending on individual patients requirements.
The aim of this study is to assess the utility of FeNO in treatment monitoring in children with asthma.
According to the aim of the study following assumptions are formulated:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •FeNO values above the norm for age and inadequate asthma control (based GINA guidelines)
排除标准
- •presence of other perennial and seasonal allergies
- •presence of other chronic diseases
- •excluded medications: systemic glucocorticosteroids 3 months before enrollment
结局指标
主要结局
Control of the disease
时间窗: 1 year
次要结局
未报告次要终点
研究者
Iwona Stelmach
MD, PhD, Professor
Medical University of Lodz