Sensitivity of Forced Oscillation Technique (FOT) in Children With Asthma and Normal Spirometry
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- R5
研究概览
简要总结
Exhibiting variable airway obstruction is a key factor in the diagnosis of asthma but too often it is undetected by spirometry.
Study hypothesis: The forced oscillation technique (FOT) will show airway obstruction in asthmatic children with normal spirometry pointing out its advantage in measuring AW obstruction in this population.
We will conduct a prospective observational study in 6-18 years old children with the diagnosis of asthma and a normal spirometry results.
Each subject will undergo evaluation including: asthma control questionnaire, spirometry, FOT and Fractional exhaled nitric oxide (FeNO) to assess the sensitivity of FOT in diagnosing airway obstruction in this circumstances.
详细描述
Background: Asthma diagnosis and control are based on history of recurrent typical symptoms and variable airflow obstruction by by measuring maximal expiratory flows with spirometry. However, in many children with asthma spirometry can be normal. The forced oscillation technique (FOT) is a simple, noninvasive technique performed during tidal breathing that is relatively easy to apply.
The objective of this study is to assess the sensitivity of FOT in children with asthma and normal spirometry.
Study design: this will be a prospective observational study. Population: 6-18 years old children visiting the pediatric pulmonary clinic at the investigators institution with the diagnosis of asthma and normal spirometry results (FEV1 & FEV1/FVC >80% and FEF25-75>65%) either on treatment or before treatment.
Study protocol:
After obtaining written informed consent, participants will fill asthma control questionnaires. Family history and risk factors for asthma will be reviewed. Data on blood eosinophils and skin prick test for allergy will be collected from the medical files. Medication (controller and reliever) will be also documented.
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 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of asthma
- •Must be able to perform spirometry and FOT tests
- •Normal spirometry results (FEV1 & FEV1/FVC >80% and FEF25-75>65%)
排除标准
- •Chronic lung disease other than asthma
- •Severe chronic medical condition such as heart failure, neuromuscular disease etc.
结局指标
主要结局
R5
时间窗: One year
Resistances at the frequency of 5 hertz in kilopascal per liter per second
R20
时间窗: One year
Resistances at the frequency of 20 hertz in kilopascal per liter per second
R5-R20
时间窗: One year
The difference between R5 to R20 in kilopascal per liter per second
Xrs 5
时间窗: One year
Reactance at the frequency of 5 hertz in kilopascal per liter
次要结局
- FeNO(One year)