NCT00884689已完成不适用
A 6 Months NIS to Evaluate the Use of Rescue Medication and Quality of Life in Adult Asthmatic Subjects Treated With Symbicort® SMART® 1-2 Inhalations b.i.d. as Maintenance Therapy Plus Additional Inhalations As-needed, Compared to Patients Treated With a Free Combination of an Inhaled Glucocorticosteroid and an Inhaled Long Acting ß2-agonist Plus as Needed Inhalations of a Short Acting ß2 Agonist.
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
- 500
- 试验地点
- 1
- 主要终点
- Use of rescue medication
研究概览
简要总结
The purpose of this study is to describe the use of rescue medication and quality of life in adult asthmatic patients, either treated with SYMBICORT SMART® (regular dose according to physician's prescription and the current summary of product characteristics - SPC) or treated with a free combination of ICS plus LABA plus as needed SABA prescribed by the physician.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
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
- •Confirmed diagnosis of asthma demonstrating a reversible obstruction during the last 5 years prior to visit
- •Patients being prescribed either Symbicort SMART or a free combination of ICS and LABA with SABA as rescue inhaler and being on that treatment for at least 3 month.
- •A history (documented in the patient's file) of at least one severe asthma exacerbation within 24 months prior to visit 1 but not within the last 30 days prior to Visit
- •A severe asthma exacerbation is defined as a deterioration of asthma leading to at least one of the following:
- •Oral/systemic GCS treatment due to asthma for at least 3 days
- •Unscheduled health-care visit due to asthmaHospitalization or emergency room visit because of asthma requiring treatment with oral/systemic GCS
排除标准
- •Intake of oral, rectal, or parenteral GCS within 30 days prior to visit
- •Use of ß-blocking agents
- •Respiratory infection affecting the asthma, as judged by the investigator, within 30 days prior to visit 1.
结局指标
主要结局
Use of rescue medication
时间窗: daily during 6 month
次要结局
- Quality of life(3 times during study)
- Efficacy variables(during 6 month)
- Safety variables(during 6 month)
研究者
研究点 (1)
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