NCT00939341已完成4 期
Real Life Effectiveness of Symbicort Maintenance and Reliever Therapy (SMART) in Asthma Patients Across Asia: SMARTASIA
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 862
- 试验地点
- 1
- 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 purpose of this study is to compare whether Symbicort Maintenance & Reliever Therapy (SMART) is more effective in uncontrolled asthmatic patients than their current therapy in a real life situation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •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
研究组 & 干预措施
1
Experimental
Symbicort Turbuhaler 160/4.5 µg delivered dose
干预措施: Symbicort (Budesonide/Formoterol) (Drug)
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: Baseline and 12 weeks
Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).
次要结局
- Change in Overall ACQ(5) Score From Baseline at Country Level (India)(Baseline and 12 weeks)
- Change in ACQ(5) Score From Baseline at Country Level (China)(Baseline and 12 weeks)
- Change in Overall ACQ(5) Score From Baseline at Country Level (Indonesia)(Baseline and 12 weeks)
- Change in Overall ACQ(5) Score From Baseline at Country Level (Taiwan)(Baseline and 12 weeks)
- Change in Overall ACQ(5) Score From Baseline at Country Level (Thailand)(Baseline and 12 weeks)
- Change in Asthma Quality of Life Questionnaire, Standardized Version (AQLQ (S)) Overall Scores From Baseline(Baseline and 12 weeks)
- Change in AQLQ (S) Domain (Symptom) Scores From Baseline(Baseline and 12 weeks)
- Change in AQLQ (S) Domain (Activity Limitation) Scores From Baseline(Baseline and 12 weeks)
- Change in AQLQ (S) Domain (Emotion Function) Scores From Baseline(Baseline and 12 weeks)
- Change in AQLQ (S) Domain (Environmental Stimuli) Scores From Baseline(Baseline and 12 weeks)
- Study Medication Use (Maintenance and Reliever) in Diary Cards - Change in As-needed Day-time Reliever Medication From run-in Period(Baseline and 12 weeks)
- Study Medication Use (Maintenance and Reliever) in Diary Cards - Change in As-needed Night-time Reliever Medication From run-in Period(Baseline and 12 weeks)
- Study Medication Use (Maintenance and Reliever) in Diary Cards - Total Number of Inhalations of Symbicort® 160µg/4.5µg Per Day During Treatment Period(Baseline and 12 weeks)
- Study Medication Use (Maintenance and Reliever) in Diary Cards - Percentage of Days During Treatment Period Participants Used ≥ 3 Inhalations of Symbicort® 160µg/4.5µg in a Day(Baseline and 12 weeks)
- Study Medication Use (Maintenance and Reliever) in Diary Cards - Percentage of Days During Treatment Period Participants Used ≥ 5 Inhalations of of Symbicort® 160µg/4.5µg in a Day(Baseline and 12 weeks)
- Study Medication Use (Maintenance and Reliever) in Diary Cards - Percentage of Days During Treatment Period Participants Used ≥ 9 Inhalations of Symbicort® 160µg/4.5µg in a Day(Baseline and 12 weeks)
研究者
研究点 (1)
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