Randomized Controlled Trial of Oral Montelukast Added to Standard Therapy for Acute Asthma Exacerbations in Children Age 6 to 14 Years
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Forced Expiratory Volume in One Second (FEV1)
研究概览
简要总结
Oral montelukast is helpful in chronic asthma. The purpose of this pediatric study was to investigate whether the addition of oral montelukast to standard therapy for acute asthma exacerbations results in further improvement in breathing function over three hours.
详细描述
We hypothesized that children with moderate acute asthma exacerbations receiving oral montelukast in addition to standard therapy will have at least 12% greater FEV1 improvement in three hours than those receiving standard therapy alone.
In this randomized double-blind placebo-controlled study, we enrolled emergency patients aged 6-14 years with moderate acute asthma exacerbations (initial PEFR 40-70% predicted). Subjects received montelukast 5-mg or placebo orally then standard therapy consisting of weight-based doses of nebulized albuterol, nebulized ipratropium bromide, and oral corticosteroids. We measured FEV1 before study medication administration and hourly for three hours.
We conducted a planned an interim analysis after approximately one-half of the estimated sample had been enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Seeking care in ED for acute asthma exacerbation
- •Age 6-14 years inclusive
- •Initial FEV1 = 40-70% predicted (defined as moderate severity)
- •Consent to participate in study
排除标准
- •Severe exacerbation requiring immediate therapy as determined by treating clinician
- •Pregnancy by history
- •Cystic Fibrosis by history
- •Tuberculosis
- •Gastroesophageal reflux disease requiring medications
- •Acute or chronic liver disease
- •Bronchopulmonary dysplasia
- •Premature <34 weeks gestational age by history
- •Having used leukotriene-modifying medication within 48 hours
- •Having used theophylline within four weeks
- •Unable to perform FEV1
结局指标
主要结局
Forced Expiratory Volume in One Second (FEV1)
次要结局
- Relapse Visit Rate
- Hospitalization Rate