Chronic Obstructive Pulmonary DiseaseEXACOS-IntlNCT04928417
Exacerbations and Their Outcomes International (EXACOS International)
An observational study of Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 21 sites in 4 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 1,762 participants
- Where
- 21 sitesin 4 countries
- Study dates
- 26 Nov 2021to 30 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
21 sites in 4 countries.
21 sites in 4 countries
Russia10 sites
Research Site
Blagoveshchensk, Russia, 675000
Research Site
Chelyabinsk, 454021
Research Site
Krasnoyarsk, 660037
Research Site
Moscow, 119991
Research Site
Omsk, 644005
Research Site
Petrozavodsk, 185019
Research Site
Saint Petersburg, 196247
Research Site
Saint Petersburg, 199106
Research Site
Voronezh, 394066
Research Site
Yekaterinburg, 620109
Taiwan8 sites
Research Site
Changhua, 50006
Research Site
Kaohsiung City, 80756
Research Site
New Taipei City, 220
Research Site
Taichung, 404332
Research Site
Taichung, 40705
Research Site
Taipei, 100225
Research Site
Taipei, 11217
Research Site
Taoyuan City, 333
About this study
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
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
Read the 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
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic obstructive pulmonary disease, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 5 YEARS
Secondary outcomes (1)
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
Measured: 1 YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start26 Nov 2021
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,762 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928417
- Sponsor's protocol ID
- D5980R00042
- Acronym
- EXACOS-Intl
- Status last verified
- Oct 2023
- First submitted
- 10 Jun 2021
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04928417
- Acronym / sponsor ID
- EXACOS-Intl / D5980R00042
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic obstructive pulmonary disease, COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,762 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 26 Nov 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 16 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Patients will be included if they meet the following inclusion criteria:
Key exclusion criteria (2 listed)
- Patients will be excluded from participation if they meet any of the following exclusion criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
1 secondary outcome
Modified Medical Research Council (mMRC) dyspnea scale measured at time of the visit
Time frame: 1 YEAR
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- EXACOS\_CSR\_Synopsis\_Final\_03Oct2023.pdfLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 21 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Russia, Taiwan, Mexico, Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimate the frequency of severe Acute exacerbation of COPD, in a COPD population (time frame: 5 YEAR). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023; AzTrials last refreshed its copy on 7 Nov 2026.