A Cross-sectional Study of COPD and Symptom Variability in MEA Countries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 3,254
- 主要终点
- Perception of symptoms variability in Chronic obstructive pulmonary disease(COPD) patients
研究概览
简要总结
This non-interventional study aims at assessing stable GOLD C and D COPD patient's perception of daily and weekly symptoms variability and their impact on daily activities.
It will also explore the current practice in management of stable GOLD C and D COPD patients.
详细描述
- Primary objective: To assess perception of daily and weekly variability of symptoms in stable GOLD C and D COPD patients and their impact on daily life activities
- Secondary objectives:
- To describe the current treatment practice for the management of GOLD C and D COPD in MEA countries and their adherence to the GOLD 2015 guidelines
- To compare patients' perception of symptoms variability and their impact on activities between Gold categories C and D
- To identify demographic, behavioral and clinical factors associated with symptoms variability.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients eligible for inclusion have to fulfill all of the following criteria:
- •Stable GOLD C or D COPD patient under maintenance treatment, over 45 years, who provided signed informed consent;
- •COPD diagnosis documented by spirometry performed in the past 12 months with an FEV1/FVC < 0.7 and an FEV1 < 50% predicted.
排除标准
- •Patients are not eligible for inclusion if they meet one of the following criteria:
- •Patient with an ongoing COPD exacerbation*;
- •Patient who has experienced an exacerbation* in the previous 3 months;
- •History of asthma, allergic rhinitis, lung cancer or any other significant respiratory disease, such as tuberculosis, lung fibrosis or sarcoidosis;
- •Inability to understand the study related questions;
- •Mentally disabled patient or unable to read and write;
- •Current participation in a clinical trial;
结局指标
主要结局
Perception of symptoms variability in Chronic obstructive pulmonary disease(COPD) patients
时间窗: 1 Year
Mean score of Morning Activities and Symptoms Questionnaires (MASQ). MASQ is a patient-reported outcome instrument developed to measure morning activities and morning symptoms. The MASQ consist of two parts that captures instant symptoms through the Global Chest Symptoms Questionnaire (GCSQ), and morning activities through the Capacity of Daily Living during the morning (CDLM) questionnaire. Each item is rated on a 5 point Likert scale, from 0 (not at all) to 4 (extremely), the total score being calculated as the average score of the two questions. Score Range a score ranging from 0 (so difficult that the activity could not be carried out by the patient on their own) to 5 (activity was not at all difficult to carry out).
Impact of symptom variability on daily life activities of Chronic obstructive pulmonary disease(COPD) Patients
时间窗: 1 Year
Percentage of patients whose daily activities are affected as captured in the Chronic obstructive pulmonary disease(COPD) Assessment Test(CAT). CAT IS a questionnaire that assesses the impact of COPD (cough, sputum, dyspnoea, chest tightens) on health status. There are eight questions with a scale of 1 to 5. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. The difference between stable and exacerbation patients was five units. No target score represents the best achievable outcome.
次要结局
- Current treatment practice for the management of COPD in Middle East Africa countries and their adherence to The Global Initiative for Chronic Obstructive Lung Disease(GOLD 2015) guidelines(1 Year)