CorRELation Between PatIent PErception of the Ability to Perform Morning Activities and Findings on Clinical Examination in COPD Patients Receiving Inhaled Combined Therapy (Corticosteroid/Long Acting ß2-agonist) - RELIEF Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 500
- 主要终点
- Change from baseline of patient's general health status upon physical evaluation - visual scale
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 correlation between patient perception of the ability to perform morning activities and the physician's assessment during a regular physical exam in patients with Chronic Obstructive Pulmonary Disease (COPD), group 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 receiving inhaled combined therapy (corticosteroid/long acting ß2-agonist) - RELIEF Study
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 Chronic Obstructive Pulmonary Disease (COPD), group C and D according to GOLD Guidelines, 2011
- •Receive inhaled combined therapy for COPD (inhaled corticosteroid / long acting ß2-agonist); this treatment should have been initiated for at least one month before entering the study
- •Current or past smokers, of at least 10 pack years
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.
结局指标
主要结局
Change from baseline of patient's general health status upon physical evaluation - visual scale
时间窗: Baseline and 3 months
Change from baseline in CDLM (Capacity of Daily Living during the Morning) questionnaire.
时间窗: Baseline and 3 months
次要结局
- Patient adherence to treatment (by using visual 5 point scale)(up to 3 months)
- Number of unscheduled visit (exacerbations, emergency visits)(up to 3 months)
- Age (years), gender (male/female), weight (kg), height (cm), place of origin (urban/rural)(Day 0 (visit 1))
- Number of daily walking steps (by using pedometers)(up to 3 months)