A RANDOMISED CONTROLLED PILOT STUDY TO EVALUATE THE EFFECT OF SYSTEMIC OMALIZUMAB AS COMPARED TO THAT OF NASAL CORTICOSTEROIDS AND ANTIHISTAMINICS ON ADENOID HYPERTROPHY IN SYMPTOMATIC PEDIATRIC PATIENTS
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Evaluation of the effect of nasal steroids and oral antihistaminics vs parenteral omalizumab on the nasopharyngoscopic findings in pediatric patients with symptomatic adenoid hypertrophy
研究概览
简要总结
Though medical treatment is available for symptomatic patients with adenoid hypertrophy, a significant proportion of them ultimately need surgical removal of this lymphoid tissue which plays a significant protective role against upper airway infections, especially in pediatric patients. There is lack of research on the possible therapeutic effect of omalizumab on adenoid hypertrophy which might provide long term shrinkage in the size of the adenoid tissue avoiding surgical intervention. We therefore intent to evaluate the effect of systemic Omalizumab on adenoid hypertrophy as compared to the current medical management by nasal steroid spray along with oral antihistamine drugs
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 5.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 5 to 14 years Symptomatic adenoid hypertrophy with at least one of these symptoms like mouth breathing or snoring or nasal obstruction or OSA or OME or recurrent ASOM or sinusitis and grade 3 or 4 adenoid hypertrophy Serum IgE levels more than 50 IU per mL with or without allergic symptoms like excessive sneezing or rhinorrhea or atopy or itching.
排除标准
- •Obstructive sleep apnoea with Pulmonary hypertension or cor pulmonale Lysosomal storage disorders or any other diseases which mandate urgent need for surgical intervention for adenoid hypertrophy Adenoid hypertrophy and serous otitis media resulting in sensorineural hearing loss.
结局指标
主要结局
Evaluation of the effect of nasal steroids and oral antihistaminics vs parenteral omalizumab on the nasopharyngoscopic findings in pediatric patients with symptomatic adenoid hypertrophy
时间窗: Baseline, 3 months and 6 months
次要结局
- Evaluation of the effect of nasal steroids and oralantihistaminics vs parenteral omalizumab on symptomatology.(3 months)
研究者
DR MANPREET
AIIMS NEW DELHI