NCT00784953已完成不适用
Real Life Effectiveness in Patients With Not Optimally Controlled Asthma: Symbicort SMART, or Other ICS/LABA With as Needed SABA
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 842
- 试验地点
- 1
- 主要终点
- Change in ACQ score from baseline to the mean of all available data from the follow up visits
研究概览
简要总结
A non-interventional study to explore actual asthma control status in real-life environment and to observe the efficacy after stepped-up to Symbicort SMART or various identical regimens.
The study will be implemented by screening asthmatic patients from respiratory clinics to identify those not optimally controlled and required stepping up the controllers to initiate, or to titrate dose of, ICS/LABA including Symbicort.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Asthma patient who was partly controlled or uncontrolled by previous controllers of ICS only, or low dose ICS plus either LABA, leukotriene modifier or theophylline; or ICS- naïve with severe and persist symptom based on physician's judgment
- •According to GINA guideline, who need to step up the controller medications, and ICS/LABA to be prescribed based on physician's discretion
排除标准
- •Patients aged not within limitation refer to label information of various product prescribed
- •Patients who have taken oral corticosteroids within 4 weeks prior to enrollment
- •Patients with contraindications to prescribed medication
结局指标
主要结局
Change in ACQ score from baseline to the mean of all available data from the follow up visits
时间窗: wk 4±1; wk 12~16
次要结局
- Change in the individual asthma control status & pulmonary function from enrollment(wk 4±1; wk 12~16)
- Dose/usage of ICS/LABA and relievers & Patient compliance(wk 4±1; wk 12~16)
- Medical resource utilization(wk 4±1; wk 12~16; 6 month; 12 month)
研究者
研究点 (1)
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