COPD (Chronic Obstructive Pulmonary Disease)SCOPeNCT06724315
Prospective and Multicentric Cohort Study of Severe and Very Severe Chronic Obstructive Pulmonary Disease (COPD) in Brazil (SCOPe).
An observational study of COPD (Chronic Obstructive Pulmonary Disease), run by Hospital Israelita Albert Einstein at 1 site in Brazil.
Trial summary
Chronic obstructive pulmonary disease (COPD) is prevalent (8-20%) and is one of the leading causes of mortality. In 2019 according to WHO it was the third highest cause of death worldwide. 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
- 1 siteBrazil
- Study dates
- 31 Jan 2025to 15 Dec 2026
- 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: The population of this study will be adult patients, both sexes, with severe and very severe COPD enrolled in the participating centers.
Who may be able to join
- Severe, very severe and symptomaitc COPD, according to GOLD definition: exposure, FEV1/FVC ratio <0,7:
- GOLD B (mMRC>=2, CAT>=10), OR
- GOLD E (>=2 moderate exacerbations or 1 severe), OR
- GOLD 3 and 4 (FEV1 <50%).
Who cannot join
- Severe interstitial lung disease (extent >50% on HRCT), OR Severe pulmonary hypertension (on triple therapy), OR Active cancer - undergoing systemic therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Israelita Albert Einstein (HIAE)
São Paulo, São Paulo, 05652-900
Francisco J N Mazon, MD, +55 11 21511233, francisco.mazon@einstein.br
About this study
Chronic obstructive pulmonary disease (COPD) is prevalent (8-20%) and is one of the leading causes of mortality. In 2019 according to WHO it was the third highest cause of death worldwide. In 2019 in Brazil respiratory diseases (Chapter J in the ICD10) were the third cause of death (176.073) with COPD (J44) accounting for 45.163 deaths (25,6% of respiratory and 3% overall). There is an upward trend for COPD mortality worldwide.
The disease also has a high morbidity leading to impairment in daily activity and quality of life.
Read more
Patients with severe and very severe disease are at a higher risk for negative outcomes, including exacerbation (up to 2-3 per patient per year). This in turn increases the risk of future exacerbations and mortality, with heightened risk lasting up to two years after each event. It is impertive to evaluate which sub-groups are at an even higher risk and could be potential targets for intervention.
"The PLATINO study" was conducted on 2004 and evaluated the prevalence of COPD in 5 cities, only one in Brazil - Sao Paulo. As the data is 20 years old it might not reflect the current epidemiological status and might not be representative of Brazil as a whole.
Understanding this population, their clinical and laboratorial characteristics can help identify sub-groups with higher risk and potential for intervention. The current prevalence, causing agent and characteristics are not known in Brazil as well as detailed outcome data.
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).
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.
- Keywords
- COPD; Exacerbation; Cardiovascular; Hospitalizations; Death;
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GOLD B; OR GOLD E | Criteria: CAT ≥10 or MMRC ≥ 2 ; OR 2 exacerbations/year or 1 exacerbation leading to hospitalization | |
| GOLD 3 OR 4 | Criteria: FVE1 < 50% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of exacerbations, hospitalizations and death.
Rate of COPD exacerbations, hospitalizations and death.
Measured: 12 months
Secondary outcomes (3)
Clinical characteristics - GOLD grade (Global Intiative for Chronic Lung Disease)
Baseline and evolution of numeric and percentual data of the clinical characteristics: GOLD grade: Global Intiative for Chronic Lung Disease according to the 2024 guidelines (ABE, 1-4),
Measured: 12 months
Clinical characteristics - spirometric parameters
Evolution of spirometric parameters (absolute in mL and % in relation to predicted). A higher value is better.
Measured: 12 months
Clinical characteristics - BMI (Body mass index)
BMI: Body mass index (BMI - kg/m^2). Absolute number and division <=21 or >21.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start31 Jan 2025
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Dec 2026 (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.
- 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
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henrique AR Fonseca, ScD, Study chair, Hospital Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06724315
- Sponsor's protocol ID
- SCOPe
- Acronym
- SCOPe
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2024
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective and Multicentric Cohort Study of Severe and Very Severe Chronic Obstructive Pulmonary Disease (COPD) in Brazil (SCOPe).
- ClinicalTrials.gov ID
- NCT06724315
- Acronym / sponsor ID
- SCOPe / SCOPe
- Keywords
- COPD; Exacerbation; Cardiovascular; Hospitalizations; Death;
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 693 participants (estimated)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Study start
- 31 Jan 2025 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 9 Dec 2024 (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.
Chronic obstructive pulmonary disease (COPD) is prevalent (8-20%) and is one of the leading causes of mortality. In 2019 according to WHO it was the third highest cause of death worldwide. In 2019 in Brazil respiratory diseases (Chapter J in the ICD10) were the third cause of death (176.073) with COPD (J44) accounting for 45.163 deaths (25,6% of respiratory and 3% overall). There is an upward trend for COPD mortality worldwide.
The disease also has a high morbidity leading to impairment in daily activity and quality of life.
Patients with severe and very severe disease are at a higher risk for negative outcomes, including exacerbation (up to 2-3 per patient per year). This in turn increases the risk of future exacerbations and mortality, with heightened risk lasting up to two years after each event. It is impertive to evaluate which sub-groups are at an even higher risk and could be potential targets for intervention.
"The PLATINO study" was conducted on 2004 and evaluated the prevalence of COPD in 5 cities, only one in Brazil - Sao Paulo. As the data is 20 years old it might not reflect the current epidemiological status and might not be representative of Brazil as a whole.
Understanding this population, their clinical and laboratorial characteristics can help identify sub-groups with higher risk and potential for intervention. The current prevalence, causing agent and characteristics are not known in Brazil as well as detailed outcome data.
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).
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
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GOLD B; OR GOLD E | – | –Criteria: CAT ≥10 or MMRC ≥ 2 ; OR 2 exacerbations/year or 1 exacerbation leading to hospitalization |
| GOLD 3 OR 4 | – | –Criteria: FVE1 < 50% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population of this study will be adult patients, both sexes, with severe and very severe COPD enrolled in the participating centers.
Key inclusion criteria (4 listed)
- Severe, very severe and symptomaitc COPD, according to GOLD definition: exposure, FEV1/FVC ratio <0,7:
- GOLD B (mMRC>=2, CAT>=10), OR
- GOLD E (>=2 moderate exacerbations or 1 severe), OR
- GOLD 3 and 4 (FEV1 <50%).
Key exclusion criteria (1 listed)
- Severe interstitial lung disease (extent >50% on HRCT), OR Severe pulmonary hypertension (on triple therapy), OR Active cancer - undergoing 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 exacerbations, hospitalizations and death.
Time frame: 12 months
Rate of COPD exacerbations, hospitalizations and death.
3 secondary outcomes
Clinical characteristics - GOLD grade (Global Intiative for Chronic Lung Disease)
Time frame: 12 months
Clinical characteristics - spirometric parameters
Time frame: 12 months
Clinical characteristics - BMI (Body mass index)
Time frame: 12 months
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 5 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Henrique AR Fonseca, ScD study chair
Hospital Albert Einstein
1 site 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 Hospital Israelita Albert Einstein at 1 site 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 4 inclusion and 1 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 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Francisco JN Mazon, MD (+55 11 21511233, francisco.mazon@einstein.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of exacerbations, hospitalizations and death. (time frame: 12 months). 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 5 Jun 2025.