A Cross-sectional Study of COPD and Symptom Variability in MEA Countries (COPVAR)
2018年6月28日 更新者:AstraZeneca
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.
研究概览
地位
完全的
条件
详细说明
- 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.
研究类型
观察性的
注册 (实际的)
3254
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Stable GOLD C or D COPD patient under maintenance treatment, over 45 years
描述
Inclusion Criteria:
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.
Exclusion Criteria:
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;
- Pregnant.
- Current participation in a clinical trial;
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Perception of symptoms variability in Chronic obstructive pulmonary disease(COPD) patients
大体时间: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).
|
1 Year
|
Impact of symptom variability on daily life activities of Chronic obstructive pulmonary disease(COPD) Patients
大体时间: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.
|
1 Year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
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
大体时间:1 Year
|
Patients whose treatment is adherent with The Global Initiative for Chronic Obstructive Lung Disease(GOLD) 2015 in Percentage
|
1 Year
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2015年12月7日
初级完成 (实际的)
2017年3月31日
研究完成 (实际的)
2017年3月31日
研究注册日期
首次提交
2018年1月22日
首先提交符合 QC 标准的
2018年2月1日
首次发布 (实际的)
2018年2月8日
研究记录更新
最后更新发布 (实际的)
2018年6月29日
上次提交的符合 QC 标准的更新
2018年6月28日
最后验证
2018年6月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- D2287R00105
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.