Monteleukast Versus Inhaled Mometasone for Treatment of Otitis Media With Effusion in Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- Treatment response
研究概览
简要总结
Otitis media is one of the most common infections among children and is a complication in about 30% of common colds. The most common complication of acute otitis media is otitis media with effusion. Some studies have reported the effects of montelukast and mometasone nasal spray in treatment of otitis media with effusion. However, current information is inadequate in this issue. The aim of this study was to compare the effectiveness of montelukast and mometasone nasal spray in treatment of otitis media with effusion in children attending Koodakan hospital in Bandar Abbas, Iran.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Children who were between 2 to 6 years old
- •Definite diagnosis of OME with symptoms and examination
排除标准
- •• Currently were using corticosteroids or prophylactic monteleukast
- •Chronic pulmonary or cardiac diseases or immune deficiency
- •Allergic rhinitis
- •Hypersensitivity to monteleukast or corticosteroids
- •Avoidance of parents to fill the written informed consent
研究组 & 干预措施
Mometasone
Inhaled mometasone 1 puff in each side of nose for one month
干预措施: Mometasone (Drug)
Montelukast
4 ml monteleukast daily for one month
干预措施: Monteleukast (Drug)
结局指标
主要结局
Treatment response
时间窗: 1 months
Defined as complete, partial, or no response based on the physician examination
次要结局
- Drug side effects(1 month)
研究者
Hamidreza Mahboobi
Principal Investigator
Hormozgan University of Medical Sciences