The Severity of Newly Diagnosed Asthma Patients and the Result of Initial 12 Weeks Treatment in China.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 4,817
- 试验地点
- 1
- 主要终点
- Asthma Severity assessment based on GINA definition (GINA 2006 update) at baseline in the total population
研究概览
简要总结
The primary objective of the NIS is to evaluate the severity of newly diagnosed asthma patients based on Global Initiative for Asthma (GINA) severity category (GINA 2006 update).
详细描述
This is a multi-centre, prospective non-interventional study planned to be conducted in China. The study aims to recruit about 5000 newly diagnosed patients from about 50 tier 3 hospitals with respiratory department. Each site recruits about 50-150 patients.
The primary variable will be distribution of severity based on GINA definition (GINA 2006 update) at baseline in the total population.
There will be 4 visits for this study, Informed consent and following study procedures (ACQ-5(asthma control questionnaire), severity assessment) will be done at visit 1. After that, according to clinical practice in China patients usually go to the clinic every 4 weeks. Asthma control status, ACQ-5 and sever exacerbation will be assessed at each clinic visit till 12 weeks (visit 2, 3, 4).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Newly diagnosed asthma patients who are not on inhaled gluococorticosteroid within 3 months.
- •Out-patient with an age of 18 years and above
- •Signed and dated informed consent The prescription of the medicinal product is clearly separated from the decision to include the subject in the NIS. Generally, asthma medication refers to those recommended in GINA guideline (GINA2012 update) and decided by investigator.
排除标准
- •Participating in any clinical trial during the last 90 days
- •With asthma exacerbation
结局指标
主要结局
Asthma Severity assessment based on GINA definition (GINA 2006 update) at baseline in the total population
时间窗: Day 1
severity based on GINA definition (GINA 2006 update) at baseline in the total population.
次要结局
- evaluate the control level of initial 12 weeks treatment based on Assessment of Current Clinical Control in GINA (GINA 2012 update).(up to 3 months)