Intranasal steroids alone and in combination with levocetirizine, and/or montelukast for moderate to severe allergic rhinitis in children: a randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- To determine the superiority of add-on therapy (INS+levocetirizine and/or montelukast) vs INS in children with moderate-severe allergic rhinitis
研究概览
简要总结
We plan to determine the superiority of combination therapy (INS+levocetirizine and/or montelukast) vs INS alone in children with moderate-severe allergic rhinitis in the age group of 6 years to 14 years. There is paucity of data on management of allergic rhinitis in the pediatric population. A double-blind, superiority, randomized control trial with 64 participants, divided into four arms with 16 participants each. Patients will be randomized into four groups:
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Group 1: INS plus placebo
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Group 2: INS plus montelukast
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Group 3: INS plus levocetirizine
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Group 4: INS plus montelukast plus levocetirizine
Efficacy of each of these interventions in the management of allergic rhinitis will be assessed by calculating effect on total nasal symptom score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 6.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •Children with moderate to severe allergic rhinitis with i) two out of four cardinal symptoms of itching, sneezing, rhinorrhea and nasal block.
- •ii) with symptoms moderate to severe in intensity-sleep disturbance, impaired sleep, impaired work/school.
排除标准
- •Recent (within last 1 month) nasal surgery.
结局指标
主要结局
To determine the superiority of add-on therapy (INS+levocetirizine and/or montelukast) vs INS in children with moderate-severe allergic rhinitis
时间窗: At enrollment, 4 weeks and then 8 weeks
次要结局
- Side effects of add-on therapy.(â— Effectiveness of treatment modalities in treating specific symptoms of AR.)
研究者
Ojasvini Bali
Department of Pediatrics