NCT00524693已完成不适用
A Double-Blind Placebo Controlled Randomized Trial of Montelukast in Acute Respiratory Syncytial Virus Bronchiolitis
Ziv Hospital0 个研究点目标入组 51 人开始时间: 2006年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 主要终点
- Length of stay
研究概览
简要总结
There is evidence of inflammatory mechanisms in RSV bronchiolitis with increased cysteinyl-leukotrienes (cys-LT). Recently, specific cys-LT receptor antagonists - montelukast (Singulair©) approved for use in infants as granule sachets, have become available. We evaluated the effect of Singulair© on clinical progress and on cytokine profiles in the acute phase of RSV bronchiolitis.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 4 Weeks 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 4 weeks < 2 years
- •Duration of respiratory symptoms < 4 days
- •Signs of bronchiolitis: prodromal rhinorrhea and cough, followed by at least two of the following signs: chest retractions, tachypnea, wheezing, or rales
- •First episode of wheezing or shortness of breath
- •Randomization within 12 hours of admission
- •No need for steroid treatment in the ward
- •Informed consent
排除标准
- •A history of asthma symptoms or any previous hospital admissions with respiratory tract illnesses and if they had ever been treated with anti-asthma medications (prior to the current illness).
- •Underlying cardiopulmonary disease such as bronchopulmonary dysplasia, congenital heart disease, immunodeficiency, or cystic fibrosis.
研究组 & 干预措施
1
Active Comparator
4mg Singulair© sachets
干预措施: Montelukast (Drug)
2
Placebo Comparator
干预措施: Placebo granules (Drug)
结局指标
主要结局
Length of stay
时间窗: hours
次要结局
未报告次要终点
研究者
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