Role of Montelukast in Asthma and Allergic Rhinitis Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Efficacy of montelukast on asthma day and night symptoms changes from baseline after 4 weeks of treatment
研究概览
简要总结
To determine the effect of Montelukast in Asthma and Allergic rhinits patients
详细描述
Montelukast is a potent and selective blocker of the CysLT1 receptor. Accordingly, a recent study has shown that Montelukast can improve symptoms of seasonal allergic rhinitis and asthma in patients with both diseases. For treatment of asthma, Montelukast is administered once daily to adults as a 10-mg film-coated tablet, to children aged 6-14 years as a 5-mg chewable tablet, and to children aged 2-5 years as a 4-mg chewable tablet form. Asthma and allergic rhinitis have been linked clinically for many years as "one airway one diseases". Patients with allergic asthma and rhinitis are significantly more likely to experience asthma attacks compared to patients with asthma alone. Side effects most commonly reported above placebo included headache, otitis media, upper respiratory infection, and pharyngitis
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
盲法说明
Montelukast is an orally active compound which binds with high affinity and selectivity to the CysLT1 receptor.Montelukast should be taken once daily in the evening
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Signed Informed Consent
- •Clinical diagnosis of Asthma and Allergic Rhinitis
排除标准
- •Previous adverse reaction to Montelukast
- •History of hyper-eosinophilic disorder other than atopic disease
- •Female subjects who are pregnant, breast-feeding
- •Any significant and active pulmonary pathology other than asthma
研究组 & 干预措施
Montelukast 10 mg
Montelukast is an orally active compound which binds with high affinity and selectivity to the CysLT1 receptor. Montelukast inhibits physiologic actions of LTD4 at the CysLT1 receptor without any agonist activity. As a result, bronchoconstriction is inhibited with decreased airway and blood eosinophil's leading to improved control over asthma and allergic rhinitis.
干预措施: Montelukast 10mg (Drug)
结局指标
主要结局
Efficacy of montelukast on asthma day and night symptoms changes from baseline after 4 weeks of treatment
时间窗: 4 weeks
To determine the efficacy of montelukast on asthma day and night symptoms changes from baseline after 4 weeks of treatment \[Designated as safety issue: No\] \[Time Frame: 0 days to 4 weeks\]
次要结局
- Efficacy of montelukast on allergic rhinitis symptoms changes from baseline after 4 weeks of treatment(4 weeks)
- Effect of montelukast in change in individual quality of life using Quality of life questionnaire after 4 weeks of treatment(4 weeks)
- Proportion of participants experiencing an adverse event (AE)(4 weeks)