Study That Will Evaluate the Brazilian Population With COPD.
SCOPe
Prospective Multicentric Cohort Study of Severe and Very Severe COPD Patients in Brazil.
1 other identifier
observational
693
1 country
10
Brief Summary
Observational, prospective, multicenter cohort study with consecutive inclusion of COPD patients. Eligible patients will be those with severe and very severe COPD according to the GOLD 2024 (Global Initiative for Chronic Obstructive Lung Disease) guidelines being followed at participating hospitals. The severity of COPD is related to the exacerbation rate, which in turn is related to the progression of the disease and the occurrence of complications and death. There is no national data on this subgroup.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2025
Typical duration for all trials
10 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
January 13, 2025
CompletedFirst Posted
Study publicly available on registry
January 17, 2025
CompletedStudy Start
First participant enrolled
January 31, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2027
June 12, 2026
June 1, 2026
2.7 years
January 13, 2025
June 11, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Incidence of hospitalizations
Any need for hospitalization involving a hospital stay of more than 24 hours
through study completion, an average of 1 year
Incidence of exacerbations
This is an acute event, with onset within 14 days, with increased symptoms: dyspnea, cough, expectoration
through study completion, an average of 1 year
Incidence of Mortality
All deaths will be reviewed, determining the main cause of the fatal outcome.
through study completion, an average of 1 year
Secondary Outcomes (2)
Incidence of vaccinated participants, with vaccines recommended by guidelines for patients with COPD
through study completion, an average of 1 year
Incidence of lung neoplasia
through study completion, an average of 1 year
Eligibility Criteria
Adults of both sexes with severe and very severe COPD being followed up at participating centers - referral hospitals distributed throughout the country. There are plans to include 693 patients from GOLD B, E, 3 and 4, who will be followed up for 12 months.
You may qualify if:
- Patients of both sexes, aged 18 years or older, with confirmed COPD according to GOLD 2024: previous or current exposure and spirometry (FEV1/FVC =2 or CAT \>=10); or
- GOLD E (\>=2 moderate or 1 severe exacerbation - hospitalization); or
- GOLD 3 and 4 (FEV1 \<50%).
You may not qualify if:
- Advanced fibrosing interstitial lung disease (extent \>=50%); and/or
- High-risk pulmonary hypertension (on triple therapy); and/or
- Active cancer - on systemic therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (10)
Research Site
Aparecida de Goiânia, Brazil
Research Site
Bahia, Brazil
Research Site
Belém, Brazil
Research Site
Brasília, Brazil
Research Site
Campo Grande, Brazil
Research Site
Florianópolis, Brazil
Research Site
Goiânia, Brazil
Research Site
Santo André, Brazil
Research Site
São Paulo, Brazil
Research Site
Uberlândia, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2025
First Posted
January 17, 2025
Study Start
January 31, 2025
Primary Completion (Estimated)
September 30, 2027
Study Completion (Estimated)
September 30, 2027
Last Updated
June 12, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer 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 anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests 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 approved.