Exacerbations and Their Outcomes International (EXACOS International)

AstraZeneca1,762 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

1,762

Conditions

Chronic Obstructive Pulmonary Disease

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients will be included if they meet the following inclusion criteria: 1. have an investigator-confirmed diagnosis of COPD of at least 5 years and are over the age of 40 years old; 2. are smokers or ex-smokers (quit smoking no longer than 15 years before the study visit); 3. have COPD-related data recorded in (electronic) medical records for at least 5 years, including spirometry and medication data; 4. have signed a written Informed Consent Form Exclusion Criteria: * Patients will be excluded from participation if they meet any of the following exclusion criteria: 1. 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

Locations (21)

Research Site

Santiago, Chile

Research Site

Guadalajara, Mexico

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 5 YEARS

Secondary Outcomes

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

Time frame: 1 YEAR

Data from ClinicalTrials.gov

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