Comparison Between the Effect of Nebulized Budesonide and Intranasal Budesonide Spray on Children With Adenotonsillar Hypertrophy: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Clinical responses including 9 symptoms (hard to awaken, witnessed apnea, breathing difficulties, snoring, sweating, mouth breathing, awakenings, restless sleep, wetting the bed)
研究概览
简要总结
Budesonide is one of the most common drugs uesd in children with adenotonsillar hypertrophy. This study aim to evaluate the efficacy of a short course of budesonide inhalation suspension via transnasal nebulization in children with adenotonsillar hypertrophy. The second aim is to compare budesonide inhalation suspension with budesonide aqueous nasal spray in adenotonsillar hypertrophy treatment.
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
- None
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children are ≥3 years and ≤10 years, have habitual mouth breathing or snoring, and without current or previous use of any corticosteroids or leukotriene receptor inhibitors within 4 weeks preceding the initial study.
排除标准
- •Children with craniofacial, neuromuscular, syndromic, or defined genetic abnormalities; acute upper respiratory tract infection; whose symptoms are not caused by adenotonsillar hypertrophy; and who have had adenotonsillectomy in the past.
研究组 & 干预措施
Nebulized Budesonide
Drug: budesonide 0.5mg/2ml Pulmicort Respules budesonide inhalation suspension(BIS) once a day (QD) oral montelukast sodium chewable tablets 4mg QD
干预措施: Nebulized Budesonide (Drug)
Intranasal Budesonide Spray
Drug: budesonide nasal spray 100μg QD oral montelukast sodium chewable tablets 4mg QD
干预措施: Intranasal Budesonide Spray (Drug)
结局指标
主要结局
Clinical responses including 9 symptoms (hard to awaken, witnessed apnea, breathing difficulties, snoring, sweating, mouth breathing, awakenings, restless sleep, wetting the bed)
时间窗: 1 month
Children's parents will be required to complete a questionnaire about 9 symptoms at diagnosis and after 1 month of therapy. Answers were scored are on a scale of 0 = never to 4 = most of the time.
Adenoid Size
时间窗: 1 month
Children's adenoid size will be estimated from lateral neck X-ray film based on the adenoidal/nasopharyngeal ratio and from nasal endoscopy based on the ratio of adenoid blocking posterior nostril. Lateral neck X-ray film and nasal endoscopy will be performed before and after the 1-month course.
次要结局
- Lung function(1 month)
- Tonsillar Size(1 month)
- Pediatric Sleep Questionnaire(PSQ) Score(1 month)
- Obstructive Sleep Apnea Questionnaire(OSA-18) Score(1 month)
- Polysomnography(1 month)
- Nasal nitric oxide(1 month)
研究者
Li Shisheng
Associate professor
Second Xiangya Hospital of Central South University