Comparison of the Effect of Montelukast and Cetirizine on Allergic Inflammation Measured by Exhaled Nitric Oxide Concentration in Children With Seasonal Allergic Rhinitis
试验速览
- 阶段
- 4 期
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- exhaled nitric oxide concentration
研究概览
简要总结
The aim of this study is to compare the effect of montelukast and cetirizine on allergic inflammation measured by exhaled nitric oxide concentration in children with seasonal allergic rhinitis.
详细描述
During the pollen season children with seasonal allergic rhinitis without concomitant asthma are at risk of having allergic inflammation in the lower respiratory tract. About 60% of children with seasonal allergic rhinitis present bronchial hyperresponsiveness and signs and symptoms of asthma.
The aim of this study is to compare the effect of montelukast and cetirizine on allergic inflammation measured by exhaled nitric oxide concentration in children with seasonal allergic rhinitis.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical symptoms of seasonal allergic rhinitis during last two seasons, moderate and severe according to ARIA guidelines
排除标准
- •diagnosis of bronchial asthma
- •allergy to perennial allergens
- •specific immunotherapy
- •other chronic diseases
- •tobacco smoking
- •acute respiratory tract infection
- •excluded drugs: inhaled and systemic glucocorticosteroids
研究组 & 干预措施
2
cetirizine
干预措施: cetirizine (Drug)
1
monteluksat sodium
干预措施: montelukast (Drug)
3
montelukast sodium and cetirizine
干预措施: montelukast and cetirizine (Drug)
4
placebo
干预措施: placebo (Drug)
结局指标
主要结局
exhaled nitric oxide concentration
时间窗: baseline (first visit), after 4 weeks (second visit) and after 6 weeks from second visit (third visit)
次要结局
- symptoms score (based on PAQLQ), bronchial hyperresponsiveness with methacholine, spirometry, PEFR measurements(baseline (first visit), after 4 weeks (second visit) and after 6 weeks from second visit (third visit))
研究者
Iwona Stelmach
MD, PhD, Professor
Medical University of Lodz