Phase 3 Study of Montelukast as Prophylaxis for Upper Respiratory Tract Infections in Children
试验速览
- 阶段
- 3 期
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- The number and duration of URI episodes
研究概览
简要总结
Viral upper respiratory tract infection (URI) is one of the most common diseases among toddlers and pre-school children.Complete and effective prevention measures for URI are currently unavailable.
Montelukast (Singulair ) is a selective leukotriene-receptor antagonist that inhibits the cysteinyl leukotriene 1 receptor. It is well tolerated and safe even in young children. Montelukast is an effective treatment for asthma (and allergic rhinitis from 1 year of age. Infections with viruses causing URI such as Influenza A, Rhinovirus and respiratory syncitial virus increases leukotriens levels in nasal secretions. Therefore, one may postulate that leukotriens inhibitors may reduce symptoms during URI. However the effect of montelukast as a treatment for non-specific cough was not properly studied and there are no studies on the effect of montelukast as prevention for URI.
Hypothesis: Prophylactic treatment with Montelukast will reduce the incidence and severity of upper respiratory infection in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children 1 to 5 years old without significant health problem.
排除标准
- •A previous history of wheezing (requiring treatment with bronchodilators in the last 3 month or more than one treatment in the last year)
- •Hospital admission due to reactive air way disease
- •Prophylactic use of montelukast or steroids
- •Chronic cardiac or respiratory disease
- •Presence of acute respiratory tract infection within the 7 days before consideration for the study
- •History of allergic Rhinitis
- •Children who are receiving chronic medications of any kind
- •Known allergy to montelukast
- •Inability to get an informed consent from a legal guardian.
研究组 & 干预措施
A
干预措施: Muntelukast (Drug)
B
干预措施: Placebo (Drug)
结局指标
主要结局
The number and duration of URI episodes
时间窗: 3 month
次要结局
- Severity of URI episodes,number of days with fever,antibiotic and antipyretic usage, unscheduled visits to physicians office, child's absence from day care or kindergarten, parental absence from work, hospital admissions and adverse reaction of the drug.(3 month)