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

NCT06724315 | Recruiting

• 1 other identifier: SCOPe
• Study Type: observational
• Target: 693
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Keywords

COPD; Exacerbation; Cardiovascular; Hospitalizations; Death;

Outcome Measures

Primary Outcomes (1)

• Incidence of exacerbations, hospitalizations and death.

  Rate of COPD exacerbations, hospitalizations and death.

  12 months

Secondary Outcomes (3)

• Clinical characteristics - GOLD grade (Global Intiative for Chronic Lung Disease)

  12 months

• Clinical characteristics - spirometric parameters

  12 months

• Clinical characteristics - BMI (Body mass index)

  12 months

Other Outcomes (9)

• 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)

  12 months

Study Arms (2)

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%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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%).

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

Study Sites (1)

Hospital Israelita Albert Einstein (HIAE)

São Paulo, São Paulo, 05652-900, Brazil

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Death

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Henrique AR Fonseca, ScD

  Hospital Albert Einstein

  STUDY CHAIR

Central Study Contacts

Francisco JN Mazon, MD

CONTACT

+55 11 21511233; francisco.mazon@einstein.br

Henrique A R Fonseca, ScD

CONTACT

+55 11 21511233; henrique.fonseca@einstein.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: December 9, 2024
• Study Start: January 31, 2025
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: June 5, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)