Asthma Exacerbations in Young Children With Moderate Asthma - Prospective Evaluation of Predictors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Number of exacerbations
研究概览
简要总结
The purpose of this study is to determine whether parameters of the pulmonary function tests and the bronchial hyperresponsiveness to methacholine are predictors of asthma exacerbations.
详细描述
Preliminary investigations from our own research group showed that lung function parameters (FEV1, the FEV1/FVC ratio and a moderate to severe hyperresponsiveness to methacholine challenge were risk factors of asthma exacerbations (OR 11.3). In the present study, these parameters will be evaluated in prospective design.
One hundred children will be included in the study. Baseline parameters will be collected in a healthy interval (visit 1), then the children will be followed up for 1 year. If the patients fulfill the criteria for an exacerbation the children will present in our department. We expect that 44% of the children have an exacerbation. All children will present at a second visit after one year (visit 2).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Age >3 and <7 years
- •Diagnosis of intermittent asthma
- •In the last 24 months, at least 6 weeks of treatment with a controller medication (inhaled steroid and / or leukotriene receptor antagonist Singulair ®), or in the last 12 months, at least three episodes with an use of controller medications (inhaled steroid and / or the leukotriene receptor antagonist Singulair ®)
- •The ability to perform three reproducible spirometries
- •Examination in infection-free interval (> 4 weeks infection-free)
- •Minimum distance to the following asthma medications:
- •Short-acting beta 2-agonists: 8 hours
- •Ipratropium bromide: 24 hours
- •Long-acting beta 2-agonists: 24 hours
- •steroids: 4 weeks
- •leukotriene antagonist: 4 weeks
排除标准
- •Age older than 6 years or younger than 4
- •The inability to perform spirometry
- •Other chronic diseases or infections (eg. HIV, tuberculosis, malignancy)
- •Participation in another study
结局指标
主要结局
Number of exacerbations
时间窗: 1 year
An exacerbations is defined as an increased need of salbutamol (more than two puffs per week or more than five puffs per two weeks). In this case patients will be followed up at our hospital and will start an anti-inflammatory therapy, if it is necessary.
次要结局
- Predictors of exacerbations like lung function, nonspecific bronchial hyperresponsiveness to methacholine, exhaled NO, specific IgE, total IgE und ECP(1 year)
研究者
Johannes Schulze MD
Cosultant Pediatric Allergy and Pulmonolgy
Johann Wolfgang Goethe University Hospital