The Effect of Singular (Montelukast) 4mg on Hypersensitivity of the Airways in Children 3-5 Years Old. + Extended Study Hyprsensitivity of the Airways in Asthmatic Children Age 3-6years
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 84
- 主要终点
- Determination of a Fall of 20% FEV1 from baseline values (PC20FEV1)
研究概览
简要总结
Rational: The possible contribution of methacholine challenge test via spirometry to the clinical diagnosis of young children with various respiratory symptoms, the most appropriate spirometry index, and the proper cutoff point concentration that will define airway sensitivity have not yet been explored. Objectives: To assess airway reactivity by spirometry in a large group of children aged 3-6years with various respiratory symptoms.
详细描述
We aimed to gather information concerning methacholine challenge test performed in children previously diagnosed with asthma (asthmatics) and 48 had prolonged cough (coughers) from the pediatric clinic at Meyer Children's Hospital.
Tests were performed by inhalation of triple-concentration increments (0.06 to13.9mg/ml/methacholine).
Spirometry was determined at baseline and after each inhalation in duplicate sets. End of test was defined by a fall of 20%FEV1 baseline (PC20-FEV1). PC20-FEV1<4.0mg/ml was considered positive). Results from the challenge were related to data from questionnaires concerning respiratory symptoms were analyzed at the end of the studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 3- to 6-years
- •respiratory diseases who were highly indicative of asthma diagnosis according to GINA guidelines [9]
- •cough duration of more than 4 weeks
- •normal chest auscultation and baseline FEV1>75% predicted for healthy preschool children, on the day of testing.
排除标准
- •presence of other chronic respiratory conditions
- •emergency room visit or the presence of respiratory infection within the last month
- •oral or inhaled steroids or other anti-inflammatory medication taken in the last two weeks
- •bronchodilator taken within 24-hours prior to the test.
结局指标
主要结局
Determination of a Fall of 20% FEV1 from baseline values (PC20FEV1)
时间窗: after intervention
次要结局
未报告次要终点