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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
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
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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Inclusion Criteria:
Patients will be included if they meet the following inclusion criteria:
Exclusion Criteria:
Patients will be excluded from participation if they meet any of the following exclusion criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Santiago | 7580023 | Chile | |||
| Research Site |
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| Label | URL |
|---|---|
| EXACOS\_CSR\_Synopsis\_Final\_03Oct2023.pdf | View source |
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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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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.
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.
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| 1 YEAR |
| 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 City | 333 | Taiwan |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |