Clinical trial NCT04928417: Exacerbations and Their Outcomes International (EXACOS International)
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic obstructive pulmonary disease
COPD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2021-06-16
Enrollment: 1762
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 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 detailed below will be included.

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Estimate the frequency of severe Acute exacerbation of COPD, in a COPD population
timeFrame: 5 YEAR
measure: c) To describe lung function decline over time (FEV1)
timeFrame: 5 YEAR
measure: Health care resource utilization in AECOPD
timeFrame: 5 YEARS
Secondary outcomes:
measure: Modified Medical Research Council (mMRC) dyspnea scale measured at time of the visit
timeFrame: 1 YEAR
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
city: Puebla
country: Mexico
facility: Research Site
city: Blagoveshensk
country: Russian Federation
facility: Research Site
state: Russia
city: Chelyabinsk
country: Russian Federation
facility: Research Site
city: Ekaterinburg
country: Russian Federation
facility: Research Site
city: Krasnoyarsk
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Omsk
country: Russian Federation
facility: Research Site
city: Petrozavodsk
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Voronezh
country: Russian Federation
facility: Research Site
city: Changhua City
country: Taiwan
facility: Research Site
city: Kaohsiung City
country: Taiwan
facility: Research Site
city: New Taipei City
country: Taiwan
facility: Research Site
city: Taichung City
country: Taiwan
facility: Research Site
city: Taichung City
country: Taiwan
facility: Research Site
city: Taipei City
country: Taiwan
facility: Research Site
city: Taipei City
country: Taiwan
facility: Research Site
city: Taoyuan City
country: Taiwan
facility: Research Site
Study officials:
References: