NCT00832455已完成4 期
A 12 Week Multicenter, Open-label, Observational Study to Evaluate the Effectiveness of Montelukast Sodium (Singulair®), 4 or 5 mg/Day in Pediatric Subjects With Uncontrolled Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 445
- 主要终点
- Asthma Control Questionnaire (ACQ)
研究概览
简要总结
a study to describe patient and physician satisfaction with montelukast therapy for the control of asthma used either as monotherapy or in combination with inhaled corticosteroids
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
- 2 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient Is Diagnosed With Asthma For At Least 6 Months
- •Patient's Peak Expiratory Flow (PEF) Is 80% Of Predicted Value (Appendix 10)
- •Patient Is Currently Untreated, Or Patient Is A User Of Short-Acting 2-Agonist On An As-Needed Basis, Or Patient Is A User Of Ics At Any Dosage
- •Physician And/Or Patient Are Dissatisfied With Current Controller Therapy, Or Patient Is Reluctant To Take Ics Therapy, Or Patient Is Insufficiently Controlled Due To Non-Adherence With Current Therapy Through The Preceding 6 Weeks
排除标准
- •As Per Canadian Guidelines, Patient Is On A Laba Alone (Formoterol (Oxeze), Salmeterol (Serevent)) Or A Combination Product (Advair Or Symbicort)
- •Patient Is Well Controlled, Adherent And Satisfied With Current Controller Therapy
研究组 & 干预措施
Montelukast
Experimental
干预措施: montelukast sodium (Drug)
结局指标
主要结局
Asthma Control Questionnaire (ACQ)
时间窗: Week 0, 4, and 12
ACQ is a questionnaire consisting of seven 7-point Likert scale questions describing frequency and severity of asthma symptoms. Score ranges between 0 (well-controlled) and 6 (extremely poorly controlled); a score of ≤0.75 indicates well controlled symptoms.
次要结局
- Asthma Control Questionnaire (ACQ)(Week 0, 4, and 12)
研究者
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