NCT00545844已完成4 期
An 8 Week Study to Evaluate the Effectiveness of Adding Montelukast to Inhaled Corticosteroid (ICS) to the ICS/Long-Acting Beta 2-Agonist Therapy in Adult Subjects With Asthma and Allergic Rhinitis
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
- 313
- 主要终点
- Asthma Control
研究概览
简要总结
Effectiveness of adding montelukast to inhaled corticosteroids in adult subjects with both uncontrolled asthma and 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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is a user of Inhaled Corticosteroid (ICS) or ICS/Long-Acting Beta 2-Agonist (ICS/LABA) at any dosage
- •Peak expiratory flow is > or = 80% of predicted value on the day of visit 1
- •Uncontrolled as per Canadian asthma consensus guidelines
排除标准
- •Unwilling to stop regular use of histamine H1 antagonists for allergic rhinitis symptoms
- •Unwilling to stop use of antihistamine eye drops or cromoglycate eye drops or ophthalmic corticosteroid
研究组 & 干预措施
1
Experimental
montelukast sodium
干预措施: montelukast sodium (Drug)
结局指标
主要结局
Asthma Control
时间窗: 8 weeks (from Week 0 to Week 8)
Asthma control was assessed by the Canadian Asthma Consensus Guidelines at week 0 and week 8. Patients were considered uncontrolled if they answered "yes" to at least 2 of the 8 asthma control parameters.
次要结局
- The Mean Change in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Score(8 weeks (from Week 0 to Week 8))
- Effectiveness of Montelukast Therapy Used in Combination With Inhaled Corticosteroids or Inhaled Corticosteroids / Long-Acting Beta 2-Agonist in Improving the Symptoms of Asthma Using the Asthma Control Questionnaire (ACQ)(8 weeks (from Week 0 to Week 8))
研究者
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