Exacerbations and Their Outcomes International (EXACOS International): Understanding Burden of Severe Exacerbations of COPD and Association Between Frequency of Severe Exacerbations Clinical and Health-care Utilization Outcomes in Less Well-resourced Countries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,762
- 试验地点
- 1
- 主要终点
- Estimate the frequency of severe Acute exacerbation of COPD, in a COPD population
研究概览
简要总结
Observational, cross-sectional study with retrospective data collection from medical records. During the cross-sectional study visit, data will be captured through the use of electronic Case Report Forms (eCRFs). As there will be only one study visit, no prospective data collection will take place, nor collection of data that are not part of the routine clinic visit.
For understanding the burden of severe exacerbations of COPD and the association between frequency of severe exacerbations and clinical and health-care utilization outcomes in less well-resourced countries
详细描述
Observational, cross-sectional study with retrospective data collection from medical records. During the cross-sectional study visit, data will be captured through the use of electronic Case Report Forms (eCRFs). As there will be only one study visit, no prospective data collection will take place, nor collection of data that are not part of the routine clinic visit.
For understanding the burden of severe exacerbations of COPD and the association between frequency of severe exacerbations and clinical and health-care utilization outcomes in less well-resourced countries
Patients, treated by pulmonologists, with an investigator-confirmed diagnosis of COPD for at least 5 years from the index date (the date that signed Informed Consent was obtained) and who meet all of the inclusion and none of the exclusion criteria
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patients will be included if they meet the following inclusion criteria:
- •have an investigator-confirmed diagnosis of COPD of at least 5 years and are over the age of 40 years old;
- •are smokers or ex-smokers (quit smoking no longer than 15 years before the study visit);
- •have COPD-related data recorded in (electronic) medical records for at least 5 years, including spirometry and medication data;
- •have signed a written Informed Consent Form
排除标准
- •Patients will be excluded from participation if they meet any of the following exclusion criteria:
- •have a diagnosis of bronchiectasis, sarcoidosis, Interstitial Lung Diseases, or Idiopathic pulmonary fibrosis. This is because differentiating deteriorations in symptoms/exacerbations in these individuals at attributing them to COPD is impossible
结局指标
主要结局
Estimate the frequency of severe Acute exacerbation of COPD, in a COPD population
时间窗: 5 YEAR
Number of severe Acute exacerbation of COPD events and interval between severe AECOPDs over the past 5 years
c) To describe lung function decline over time (FEV1)
时间窗: 5 YEAR
At least 2 (Forced expiratory volume in 1 second)FEV1 measurements at least 6 months apart
Health care resource utilization in AECOPD
时间窗: 5 YEARS
Number of hospitalizations due to AECOPD in 60 months prior to study visit and time between hospitalizations
次要结局
- Modified Medical Research Council (mMRC) dyspnea scale measured at time of the visit(1 YEAR)