Exacerbations and Their Outcomes International (EXACOS International)

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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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

Conditions
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Chronic Obstructive Pulmonary Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate the frequency of severe Acute exacerbation of COPD, in a COPD population | Number of severe Acute exacerbation of COPD events and interval between severe AECOPDs over the past 5 years | 5 YEAR | 
| c) To describe lung function decline over time (FEV1) | At least 2 (Forced expiratory volume in 1 second)FEV1 measurements at least 6 months apart | 5 YEAR | 
| Health care resource utilization in AECOPD | Number of hospitalizations due to AECOPD in 60 months prior to study visit and time between hospitalizations | 5 YEARS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Medical Research Council (mMRC) dyspnea scale measured at time of the visit | Modified Medical Research Council (mMRC) dyspnea questionnaire to asses the grade as follow: Grade 0: I only get breathless with strenuous exercise Grade 1: I get short of breath when hurrying on the level or walking up a slight hill Grade 2: I walk slower than people of the same age on the level because of breathlessness, or I have to stop for breath when walking on my own pace on the level Grade 3: I stop for breath after walking about 100 meters or after a few minutes on the level Grade 4: I am too breathless to leave the house or I am breathless when dressing or undressing | 1 YEAR | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic obstructive pulmonary disease, COPD