Exacerbations and Their Outcomes International (EXACOS International) (EXACOS-Intl)

AstraZeneca

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT04928417

D5980R00042

Details and patient eligibility

About

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

Full description

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

Enrollment: 1,762 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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