CTRI/2009/091/000562已完成4 期
Real life Effectiveness of Symbicort Maintenance and Reliever Therapy (SMART) in Asthma Patients across Asia: SMARTASIA
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,150
- 试验地点
- 12
- 主要终点
- Change in Asthma Control Questionnaire (ACQ(5)) score from baseline at a regional level
研究概览
简要总结
The propose of this study is to compare whether Symbicort Maintence & Reliever Therapy (SMART) is more effective in uncontrolled asthmatic patients than their current therapy in a real life situation. Of 1150 patients planned regionally for the study, India enrolled 176 patients in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Provision of signed informed consent.
- •Asthma diagnosis at least 6 months before visit 1 of study.
- •Patients who have reversible airway obstruction continuous asthma treatment except Symbicort at least within 4 weeks before visit 1 of study.
排除标准
- •Known or suspected allergy to active ingredients of study medication or excipients- Use of oral, rectal or parenteral glucocorticosteroids 30 days before visit 1 of study- Smoking, current or previous with a smoking history of ≥10 pack years.
结局指标
主要结局
Change in Asthma Control Questionnaire (ACQ(5)) score from baseline at a regional level
时间窗: At initiate study treatment visit with 3 further visits at 4, 8 and 12 weeks
次要结局
- Change in ACQ (5) score from baseline at country level(At initiate study treatment visit with 3 further visits at 4, 8 and 12 weeks)
- Change in Asthma Quality of Life Questionnaire, standardized version (AQLQ (S)) domain and overall scores from baseline(At initiate study treatment visit with 3 further visits at 4, 8 and 12 weeks)
- Study medication use (maintenance and reliever) in Diary Cards(At initiate study treatment visit with 2 further visits at 4 and 8 weeks)
研究者
研究点 (12)
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