A 12 Week Multicenter, Open-Label, Randomized, Observational Study Comparing Singulair® 10 Mg As Controller Monotherapy In Adults With Mild Asthma "To Low Dose" Inhaled Corticosteroid Treatment

Organon and Co0 个研究点目标入组 399 人开始时间: 2002年9月最近更新: 2024年8月15日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: Organon and Co
入组人数: 399
主要终点: Canadian asthma guidelines criteria

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

In adult patients with mild persistent asthma, singulair® 10 mg will be at least as effective as low dose Inhaled Corticosteroids (ICS) in improving asthma symptom control or satisfaction over a 6 week comparison period.

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: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•First time diagnosis of mild asthma symptoms which requires an antiinflammatory controller medication
•Patients not controlled with short acting beta2 agonist (sab) therapy (requiring more than one treatment per week but less than 7 per week)
•Patients dissatisfied with low dose ics therapy, or patients reluctant to take ics therapy, or patients insufficiently controlled due to non-compliance with low dose ics therapy through out the preceding 6 weeks
•Patient's forced expiratory volume in one second (fev1) is < 80% of predicted value

排除标准

•Patient on combination therapy
•Patient on long acting beta2 agonists
•Patient on using moderate to high doses of ICS. (ICS >250 &micro g/day flovent® or equivalent per day)

结局指标

主要结局

Canadian asthma guidelines criteria

次要结局

Asthma control questionnaire

研究者

发起方

Organon and Co

申办方类型

Industry

责任方

Sponsor

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