Perception of Symptom Variability in Chinese COPD Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,058
- 试验地点
- 1
- 主要终点
- The variability of symptoms due to COPD throughout the day
研究概览
简要总结
The objective of the study is to assess patient's perception with stable state COPD on symptom variability and to describe how symptom variability impacts daily quality of life in Chinese COPD patient with moderate, severe or very severe airflow limitation from tier 3 hospitals in China where most of COPD patients are diagnosed and treated.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of subject informed consent
- •Out-patient
- •Clinical diagnosis of COPD at least 6 months
- •Lung function based on data available within 3 months in medical records confirming FEV1<80% normal predicted (post-bronchodilator) and FEV1/FVC<0.7 (post-bronchodilator)
排除标准
- •Participation in any interventional study involving investigational drugs; Patient inability to understand the study procedures or inability/reluctance to answer questionnaire
- •Ongoing exacerbation of COPD or exacerbation within the previous 3 months. An exacerbation is defined as a worsening of COPD symptoms leading to a treatment with antibiotics and/or a short course of system steroids and/or hospitalisation or emergency
- •History of asthma and/or allergic rhinitis, Lung cancer or any other significant respiratory disease such as bronchiectasis, lung fibrosis, interstitial lung disease, tuberculosis, sarcoidosis
结局指标
主要结局
The variability of symptoms due to COPD throughout the day
时间窗: Day 1
* To ask subject, which symptoms（breathlessness, chest tightness, coughing, wheezing, phlegm）is COPD symptoms and exist throughout the day * To ask subject , whether COPD symptoms variability throughout the day exists or not ; * To ask subject , which (on waking, later in the morning, in the afternoon, in the evening, at night) is the most likely occurring time of these symptoms; * To ask subject , Which (on waking, later in the morning, in the afternoon, in the evening, at night) is the most troublesome time of these symptoms.
次要结局
- The impact of COPD symptoms on patient's daily living activities and sleep quality(Day 1)
- Total CAT score(Day 1)
- Total MMRC score(Day 1)
- The impact of COPD symptoms on morning activities(Day 1)
- Patient's perception on COPD and COPD treatments(Day 1)