A Prospective, Open Label, Single-center Study of the Long-term Prognosis of Moderate to Severe Bronchial Hyperresponsiveness (BHR) in Asthmatic Preschool Children.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Change of severe bronchial hyperresponsiveness over time of five years.
研究概览
简要总结
The aim of investigator´s clinical trial is to investigate 52 patients aged three to five years with viral-induced asthma and 52 patients aged three to five years with allergic asthma. Over a time-span of 5 years the investigators will explore lung function and bronchial responsiveness. The investigators plan to evaluate long-term clinical history of moderate to severe bronchial hyperresponsiveness in preschool children with asthma. Therefore factors like atopy in children, parental atopy and bronchial hyperresponsiveness will be explored.
详细描述
A positive family history with prevalence of atopy, eczema, wheezing are well-known factors predicting asthma. Caudri et al. found more important predictors like perinatal transmission, parental use of inhalative medications and wheezing/dyspnea out of viral infections(5). Measurement of BHR in children was in most studies a second outcome parameter.
Four visits will be performed, baseline and after 1, 3, and 5 years. At visit 1 the investigators will characterize all patients by a ISAAC survey. At each visit in children a methacholine challenge, a skin Prick test, eNO, RAST and total IgE will be performed. At visit 3 and 4 sputum will be induced. In parents only at the first visit a methacholine challenge will be performed. A genetic identification of ADAM33 gene from EDTA blood shall be provided. ADAMs are multidomain proteins with a metalloprotease domain, associated with airway remodelling. Visits should be kept in a time interval without asthma therapy and respiratory infection.
To examine the feasibility of methacholine challenges in preschool children data measured in 2006 will be analysed.
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
- 3 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •informed consent
- •age 3 to 6 years
- •diagnosis asthma
- •pulmonary function: FEV1 (% pred.)≥ 70%
- •ability to carry out 2 reproducible flow volume loops
- •moderate to severe BHR (PD20 FEV1 ≤ 0,3 mg methacholine)
- •more than 4 weeks interval since last infection
- •8 hours washout period of Short Acting Beta Agonist
- •1 week washout period of Ipratropium Bromide
- •1 week washout period of Long Acting Beta Agonist
- •4 weeks washout period of Systemic Corticosteroids
- •4 weeks washout period of Leukotriene Antagonists
排除标准
- •Age < 3 and > 6 Years
- •Pulmonary function test: FEV1 (% pred.) < 70%
- •Others chronic diseases or infections (e.g., HIV, tuberculosis, malignancy)
- •Incapability to perform spirometry
- •Current participation in another clinical trial
结局指标
主要结局
Change of severe bronchial hyperresponsiveness over time of five years.
时间窗: five years
Bronchial hyperresponsiveness will be defined by the provocation dose (PD) of methacholine causing a 20% drop of FEV1 (PD-20FEV1).
次要结局
- eNO(five years)
- Bronchial responsiveness of parents(two years)
- Impact of atopy(five years)
- Total-IgE(five years)
研究者
Johannes Schulze MD
Cosultant, Pediadric Allergy, Pulmonology and Cystic fibrosis
Johann Wolfgang Goethe University Hospital