An Open Label, Observational Study to Assess The Efficacy, Safety and Tolerability of Added Singulair in Persistent Asthma Patients With or Without Allergic Rhinitis and Long Acting B-Agonist

Organon and Co0 个研究点目标入组 198 人开始时间: 2005年11月1日最近更新: 2024年8月15日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Organon and Co
入组人数: 198
主要终点: Change of the asthma control questionnaire scores taken over 8 weeks

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to assess the treatment effect of montelukast 10mg on the primary endpoint of Asthma Control Questionnaire(ACQ), over a 8-week period, in persistent asthma patients with or without allergic rhinitis.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 15 Years 至 80 Years（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patient is currently a nonsmoker and has been a nonsmoker for at least 1 year
•Patient with clinical evidence of mild/moderate asthma with or without allergic rhinitis

排除标准

•Patient has been treated in an emergency room for asthma within 4 weeks or has been hospitalized for asthma within 3 months prior to visit 1
•Patient with severe asthma, upper respiratory infection, sinusitis, infectious rhinitis, non-allergic rhinitis
•Patient has any active, acute, or chronic pulmonary disorder that is documented by history, physical examination

结局指标

主要结局

Change of the asthma control questionnaire scores taken over 8 weeks

次要结局

未报告次要终点

研究者

发起方

Organon and Co

申办方类型

Industry

责任方

Sponsor

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