CorRELation Between PatIent PErception of the Ability to Perform Morning Activities and Findings on Clinical Examination in COPD Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 505
- 试验地点
- 1
- 主要终点
- Change from baseline in Capacity of Daily Living during the Morning (CDLM) Questionnaire
研究概览
简要总结
This is a multi-center, prospective, non-interventional study that aims to evaluate in daily clinical practice, the possible corelation between patIent perception of the ability to perform morning activities and physician evaluation; patients with COPD, grade C and D.
详细描述
CorRELation between PatIent PErception of the Ability to Perform Morning Activities and Findings on Clinical Examination in COPD Patients
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Diagnosis of COPD, grade C and D according to GOLD Guidelines Revised 2011
- •Current or past smokers, of at least 10 pack years
- •Receive any inhaled combination therapy for COPD (inhaled corticosteroid / long acting β2-agonist bronchodilator) initiated for at least one month before entering in the study
排除标准
- •History of exacerbation of COPD symptoms within the last month before visit 1, inclusive; history of asthma or allergic rhinitis; history of lung carcinoma or any other respiratory condition that may limit the airflow circulation
- •Inability to understand study procedures and inability/refuse to complete CDLM questionnaires and/or record the values showed on the pedometer screen
结局指标
主要结局
Change from baseline in Capacity of Daily Living during the Morning (CDLM) Questionnaire
时间窗: Baseline and 3 months
CDLM questionnaire is a simple self-reporting tool of the burden and ability of COPD patients to perform routine morning activities: washing, dressing, eating breakfast, walking around. For each of these morning activities the score is varying from 0 (indicating worst case) to 5 (indicating best case).
Change from baseline of patient's general health status based upon physician evaluation - visual scale
时间窗: Baseline and 3 months
General health status visual scale is assessing the physicians perception of the patient health status following the clinical examination. Based upon clinical evaluation, the physician will indicate the patient's general condition on a a scale consisting of 5 levels. The scale will be completed at each visit and the score can vary from 1(very bad general health status) to 5 (very good general health status) .
次要结局
- Demographic patient characteristics(Day 0 (visit1))
- Patient adherence to treatment - visual scale(up to 3 months)
- Number of daily walking steps (using pedometer)(up to 3 months)
- Number of exacerbations(up to 3 months)