Exacerbations and Their Outcomes International (EXACOS International)
EXACOS-Intl
1 other identifier
observational
1,762
4 countries
21
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2021
Shorter than P25 for all trials
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2021
CompletedFirst Posted
Study publicly available on registry
June 16, 2021
CompletedStudy Start
First participant enrolled
November 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedOctober 18, 2023
October 1, 2023
1 year
June 10, 2021
October 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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
5 YEARS
Secondary Outcomes (1)
Modified Medical Research Council (mMRC) dyspnea scale measured at time of the visit
1 YEAR
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (21)
Research Site
Santiago, 7580023, Chile
Research Site
Guadalajara, 44670, Mexico
Research Site
Puebla City, 72450, Mexico
Research Site
Blagoveshchensk, Russia, 675000, Russia
Research Site
Chelyabinsk, 454021, Russia
Research Site
Krasnoyarsk, 660037, Russia
Research Site
Moscow, 119991, Russia
Research Site
Omsk, 644005, Russia
Research Site
Petrozavodsk, 185019, Russia
Research Site
Saint Petersburg, 196247, Russia
Research Site
Saint Petersburg, 199106, Russia
Research Site
Voronezh, 394066, Russia
Research Site
Yekaterinburg, 620109, Russia
Research Site
Changhua, 50006, Taiwan
Research Site
Kaohsiung City, 80756, Taiwan
Research Site
New Taipei City, 220, Taiwan
Research Site
Taichung, 404332, Taiwan
Research Site
Taichung, 40705, Taiwan
Research Site
Taipei, 100225, Taiwan
Research Site
Taipei, 11217, Taiwan
Research Site
Taoyuan, 333, Taiwan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2021
First Posted
June 16, 2021
Study Start
November 26, 2021
Primary Completion
November 30, 2022
Study Completion
November 30, 2022
Last Updated
October 18, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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.