A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Incidence of Acute Otitis Media
研究概览
简要总结
The objective of this pilot study is to evaluate the efficacy of treatment with montelukast as compared to placebo in the prevention of recurrence of acute Otitis media (AOM)
详细描述
Otitis media (OM) is one of the most common childhood disorders requiring physician care and has been associated with an alarming rise in prevalence. Certain children are prone to recurrent episodes of acute Otitis media (RAOM) and/or the development of chronic Otitis media with effusion (COME). Because medical therapy with antibiotics, antihistamines, decongestants and corticosteroids has no demonstrable efficacy, the mainstay of treatment is surgical intervention, which is quite expensive and exposes patients to risks of general anesthesia. The objective of this pilot study is to evaluate the efficacy of treatment with montelukast as compared to placebo in the prevention of recurrence of acute Otitis media (AOM)
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 months to 5 years old.
- •Diagnosis of current AOM
排除标准
- •Presence of primary or secondary immunodeficiency, craniofacial abnormality, cleft palate, anatomic predisposition, major congenital anomaly or syndrome, or severe systemic disease
- •Any investigational medications within the past 30 days, systemic or oral or nasal steroids within the past 30 days
- •Accolate® in the past 7 days
- •Antibiotics within the past week, except for Zithromax®, which will be 21 days
- •Long acting second generation antihistamines (i.e., Claritin®, Clarinex®, Allegra® and Zyrtec®) within the past 72 hours.
- •No known allergy to either montelukast or amoxicillin/clavulanate
- •Have not responded to Augmentin® in the past
研究组 & 干预措施
Montelukast
Treatment with montelukast for 4 months (4 mg per day)
干预措施: Montelukast (Drug)
Placebo
Treatment with placebo for 4 months
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Acute Otitis Media
时间窗: 16 weeks
次要结局
未报告次要终点
研究者
Deborah Gentile
Co- Investigator, Asthma & Allergy Dept
West Penn Allegheny Health System