Actively Recruiting

Age: 18Years +
All Genders
NCT06724315

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

Led by Hospital Israelita Albert Einstein · Updated on 2025-06-05

693

Participants Needed

1

Research Sites

97 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Severe, very severe, and symptomatic COPD according to GOLD definition
  • GOLD B with mMRC score 2 or higher, or CAT score 10 or higher
  • GOLD E with 2 or more moderate exacerbations or 1 severe exacerbation
  • GOLD stages 3 and 4 with FEV1 less than 50%
Not Eligible

You will not qualify if you...

  • Severe interstitial lung disease affecting more than 50% of the lungs on HRCT
  • Severe pulmonary hypertension requiring triple therapy
  • Active cancer undergoing systemic therapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital Israelita Albert Einstein (HIAE)

São Paulo, São Paulo, Brazil, 05652-900

Actively Recruiting

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Research Team

F

Francisco JN Mazon, MD

CONTACT

H

Henrique A R Fonseca, ScD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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