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Completed

NCT Number: NCT04928417

Exacerbations and Their Outcomes International (EXACOS International)

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

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Santiago, Chile

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Estimate the frequency of severe Acute exacerbation of COPD, in a COPD population

    Time frame: 5 YEAR

    Number of severe Acute exacerbation of COPD events and interval between severe AECOPDs over the past 5 years

  2. c) To describe lung function decline over time (FEV1)

    Time frame: 5 YEAR

    At least 2 (Forced expiratory volume in 1 second)FEV1 measurements at least 6 months apart

  3. Health care resource utilization in AECOPD

    Time frame: 5 YEARS

    Number of hospitalizations due to AECOPD in 60 months prior to study visit and time between hospitalizations

Secondary outcomes

  1. Modified Medical Research Council (mMRC) dyspnea scale measured at time of the visit

    Time frame: 1 YEAR

    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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: EXACOS-Intl

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 16, 2021
Registry last updated
Oct 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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