Prospective and Multicentric Cohort Study of Severe and Very Severe Chronic Obstructive Pulmonary Disease (COPD) in Brazil (SCOPe). (SCOPe)

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.

Study Overview

• Status: Recruiting
• Conditions: COPD (Chronic Obstructive Pulmonary Disease)

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 Type: Observational
• Enrollment (Estimated): 693

Contacts and Locations

• Study Contact: Name: Francisco JN Mazon, MD; Phone Number: +55 11 21511233; Email: francisco.mazon@einstein.br
• Study Contact Backup: Name: Henrique A R Fonseca, ScD; Phone Number: +55 11 21511233; Email: henrique.fonseca@einstein.br

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 05652-900
      • Recruiting
      • Hospital Israelita Albert Einstein (HIAE)
      • Contact: Francisco J N Mazon, MD; Phone Number: +55 11 21511233; Email: francisco.mazon@einstein.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The population of this study will be adult patients, both sexes, with severe and very severe COPD enrolled in the participating centers.

Description

Inclusion Criteria:

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%).

Exclusion Criteria:

Severe interstitial lung disease (extent >50% on HRCT), OR Severe pulmonary hypertension (on triple therapy), OR Active cancer - undergoing systemic therapy.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of exacerbations, hospitalizations and death.	Rate of COPD exacerbations, hospitalizations and death.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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),	12 months
Clinical characteristics - spirometric parameters	Evolution of spirometric parameters (absolute in mL and % in relation to predicted). A higher value is better.	12 months
Clinical characteristics - BMI (Body mass index)	BMI: Body mass index (BMI - kg/m^2). Absolute number and division <=21 or >21.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of exacerbations		12 months
Incidence of non-fatal cerebrovascular and cardiovascular events		12 months
Description of symptoms according to CAT score (COPD assessment test)	CAT: COPD assessment test score from 0-40, higher is more symptomatic.	12 months
Rate of decline in forced exprired volume in first second (FEV1)	Baseline to 12 months.	12 months
Description of quality of life score SGRQ-C (St. George Respiratory Questionaire - COPD)	SGRQ-C: St. George Respiratory Questionaire - COPD. The Total score is calculated by summing the weights to all the positive responses in each component. Score ranges from 0 to a Total (sum of maximum for all three components) 3201.9. Higher score is worse.	12 months
Description of symptoms according to mMRC (Modified Medical Research Council dyspnea scale)	mMRC: Modified Medical Research Council (dyspnea scale) 0-4, higher is worse	12 months
Description of symptoms 6MWT (6 minutes walk test)	6MWT: 6 minutes walk test (meters) 0-1000m, above 1000m is highly improbable, higher is better.	12 months
Description of treatment	Description of medication classes and dosages in use.	12 months
Clinical characteristics - laboratory data	Recent laboratory data will be analyzed and collected when available (e.g., eosinophils absolute count/mcL and %, IgE KU/L, chest CT report in pdf).	12 months

Collaborators and Investigators

• Sponsor: Hospital Israelita Albert Einstein
• Investigators: Study Chair: Henrique AR Fonseca, ScD, Hospital Albert Einstein

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2025
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: November 18, 2024
• First Submitted That Met QC Criteria: December 6, 2024
• First Posted (Actual): December 9, 2024

Study Record Updates

• Last Update Posted (Estimated): June 5, 2025
• Last Update Submitted That Met QC Criteria: June 2, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: COPD; Exacerbation; Cardiovascular; Hospitalizations; Death
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: SCOPE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No