NCT00863317已完成不适用
A Randomized, Double Blind, Placebo Controlled Trial of Daily Montelukast for the Treatment of Viral Bronchiolitis
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
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- Duration of Cough
研究概览
简要总结
The primary rationale for this study is to evaluate the effect of once daily montelukast on duration of acute illness in infants with first-time 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female infants aged 3 to 12 months of age
- •Diagnosis by emergency physician of bronchiolitis
排除标准
- •Any previous episode, as determined by a physician, of wheezing, bronchiolitis or asthma
- •Any history of previous bronchodilator use prior to this illness
- •Treatment with corticosteroids in the 14 days prior to the current illness
- •Immunosuppression
- •Immunodeficiency
- •Caregiver does not speak English
- •Diagnosis by the treating ED physician of croup
- •Diagnosis by the treating ED physician of pneumonia
- •Caregiver does not have access to a telephone
研究组 & 干预措施
montelukast sodium
Experimental
4mg granules PO QD for 14 days
干预措施: montelukast sodium (Drug)
Placebo
Placebo Comparator
Sucrose granules PO QD for 14 days
干预措施: sucrose (Other)
结局指标
主要结局
Duration of Cough
时间窗: up to 4 weeks
次要结局
未报告次要终点
研究者
Frank Petruzella
Pediatric Emergency Physician
Medical College of Wisconsin
研究点 (1)
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