Open Label Pilot Trial, Evaluating the Role of Nasonex in the Management of Nasal Obstruction Secondary to Adenoids Hypertrophy in Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 34
- 主要终点
- Number of Participants Referred to Surgery (Adenoidectomy) Within 12 Weeks of Start of Therapy
研究概览
简要总结
To document the short term & long term effect of treatment with Nasonex (mometasone furoate nasal spray) in moderate to severe adenoids hypertrophy (which cause > 50% obstruction of the posterior choanae).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •2-11 years of age, nasal obstruction for 3 months, adenoids hypertrophy > 50% of posterior choanae.
排除标准
- •adenoids hypertrophy < 50% of posterior choanae
- •recurrent epistaxis or immunodeficiency, severe septal deviation, kissing tonsils, choanal atresia, large masses, known allergy to nasonex (mometasone furoate nasal spray), chronic otitis media, cystic fibrosis, acute infection.
研究组 & 干预措施
mometasone furoate nasal spray
干预措施: mometasone furoate nasal spray (Drug)
结局指标
主要结局
Number of Participants Referred to Surgery (Adenoidectomy) Within 12 Weeks of Start of Therapy
时间窗: Baseline to 12 weeks
Severity of Nasal Obstruction Symptoms at Baseline and Week 12 as Measured by the Total Clinical Score
时间窗: Baseline and Week 12
Clinical score (based on a 5 point grading system) was assessed for each of 5 nasal obstruction symptoms (oral/mouth breathing, snoring, restless sleep, frequent waking-ups during the night, and obstructive breathing during sleep). Each nasal obstruction symptom was estimated by the parent/guardian of the participant and scored on a scale of 0 (best) to 1 (worst). Total clinical score is a score on a scale (0 = no symptoms \[best score\] and 5 = worst symptoms \[worst score\]).
Degree of Posterior Choana Obstruction at Baseline and Week 12
时间窗: Baseline and Week 12
The degree of obstruction of the posterior choana was assessed by endoscopy. Endoscopy grading consisted of Grade I (minimum), Grade II and Grade III (maximum). Grade I was defined as \<50% obstruction, Grade II was defined as 50-75% obstruction, and Grade III was defined as \>75% obstruction.
次要结局
- Severity of Rhinorrhea at Baseline and Week 12(Baseline and Week 12)
- Severity of Eye Symptoms at Baseline and Week 12(Baseline and Week 12)
- Severity of Nasal Congestion at Baseline and Week 12(Baseline and Week 12)
- Severity of Nasal Itching at Baseline and Week 12(Baseline and Week 12)
- Severity of Sneezing at Baseline and Week 12(Baseline and Week 12)