COPD (Chronic Obstructive Pulmonary Disease)SCOPeNCT06780046
Study That Will Evaluate the Brazilian Population With COPD.
An observational study of COPD (Chronic Obstructive Pulmonary Disease), run by AstraZeneca at 10 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease)
- How many people
- 693 participants
- Where
- 10 sitesBrazil
- Study dates
- 31 Jan 2025to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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%).
Who cannot join
- Advanced fibrosing interstitial lung disease (extent >=50%); and/or
- High-risk pulmonary hypertension (on triple therapy); and/or
- Active cancer - on systemic therapy
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
10 sites in 1 country
Brazil10 sites, 10 recruiting
- Recruiting
Research Site
Aparecida de Goiânia
- Recruiting
Research Site
Bahia
- Recruiting
Research Site
Belém
- Recruiting
Research Site
Brasília
- Recruiting
Research Site
Campo Grande
- Recruiting
Research Site
Florianópolis
- Recruiting
Research Site
Goiânia
- Recruiting
Research Site
Santo André
- Recruiting
Research Site
São Paulo
- Recruiting
Research Site
Uberlândia
About this study
Official title: Prospective Multicentric Cohort Study of Severe and Very Severe COPD Patients in Brazil.
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.
Read the detailed description
This is a prospective multicentre cohort, non-interventional study. The design is to have multiple medical centres representing the regions of Brazil. Each region has a different exposure to risk factors like tobacco smoke, biomass burning and environmental pollution, has a different population composition and density, degree of urbanization and education level. There are also some inferred genetic differences due to previous colonization and miscegenation. *CAT (COPD Assessment Test) OU CAAT (Chronic Airway Assesment Test) poderão ser usados intercambiavelmente. The patients will be enrolled in non-random consecutive method and will be followed up for 12 months.
There will be on-site visits at inclusion (V0), 6 and 12 months. There will tele-consults at 3 and 9 months to gather relevant clinical data, with special interest at exacerbation.
There will be 8 participating centres in Brazil, representing all 5 regions (North, Northeast, Midwest, Southeast and South). They will be Teaching Hospitals, Regional Reference Hospitals, Tertiary Hospitals or High Complexity Hospitals. The data will be collected on each site and will be adjudicated by the ARO Team.
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hospitalizations
Any need for hospitalization involving a hospital stay of more than 24 hours
Measured: 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
Measured: through study completion, an average of 1 year
Incidence of Mortality
All deaths will be reviewed, determining the main cause of the fatal outcome.
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Incidence of vaccinated participants, with vaccines recommended by guidelines for patients with COPD
Vaccination rate for influenza, SARS-CoV-2, pneumococcus, adult double (or acellular triple bacterial) and triple viral.
Measured: through study completion, an average of 1 year
Incidence of lung neoplasia
Results of any biopsies should be noted in the participant's medical record
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start31 Jan 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies 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
- Prospective
- Enrolment
- 693 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780046
- Sponsor's protocol ID
- D5980R00117
- Acronym
- SCOPe
- Status last verified
- Oct 2026
- First submitted
- 13 Jan 2025
- Last updated
- 16 Oct 2026
- 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 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicentric Cohort Study of Severe and Very Severe COPD Patients in Brazil.
- ClinicalTrials.gov ID
- NCT06780046
- Acronym / sponsor ID
- SCOPe / D5980R00117
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 693 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 17 Jan 2025 (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, 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.
Detailed description
This is a prospective multicentre cohort, non-interventional study. The design is to have multiple medical centres representing the regions of Brazil. Each region has a different exposure to risk factors like tobacco smoke, biomass burning and environmental pollution, has a different population composition and density, degree of urbanization and education level. There are also some inferred genetic differences due to previous colonization and miscegenation. *CAT (COPD Assessment Test) OU CAAT (Chronic Airway Assesment Test) poderão ser usados intercambiavelmente. The patients will be enrolled in non-random consecutive method and will be followed up for 12 months.
There will be on-site visits at inclusion (V0), 6 and 12 months. There will tele-consults at 3 and 9 months to gather relevant clinical data, with special interest at exacerbation.
There will be 8 participating centres in Brazil, representing all 5 regions (North, Northeast, Midwest, Southeast and South). They will be Teaching Hospitals, Regional Reference Hospitals, Tertiary Hospitals or High Complexity Hospitals. The data will be collected on each site and will be adjudicated by the ARO Team.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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%).
Key exclusion criteria (3 listed)
- Advanced fibrosing interstitial lung disease (extent >=50%); and/or
- High-risk pulmonary hypertension (on triple therapy); and/or
- Active cancer - on systemic therapy
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
Incidence of hospitalizations
Time frame: through study completion, an average of 1 year
Any need for hospitalization involving a hospital stay of more than 24 hours
Incidence of exacerbations
Time frame: through study completion, an average of 1 year
This is an acute event, with onset within 14 days, with increased symptoms: dyspnea, cough, expectoration
Incidence of Mortality
Time frame: through study completion, an average of 1 year
All deaths will be reviewed, determining the main cause of the fatal outcome.
2 secondary outcomes
Incidence of vaccinated participants, with vaccines recommended by guidelines for patients with COPD
Time frame: through study completion, an average of 1 year
Incidence of lung neoplasia
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- 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 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.
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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.
AstraZeneca Clinical Study Information Center contact
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD (Chronic Obstructive Pulmonary Disease), run by AstraZeneca at 10 sites in Brazil.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Brazil. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hospitalizations (time frame: through study completion, an average of 1 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 16 Oct 2026.