Tracking severe and very severe COPD across Brazil

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

This project will follow people with severe or very severe COPD in Brazil for one year to see which groups have higher risk of exacerbations, hospital stays, heart problems, or death.

Quick facts

• Study type: Observational
• Enrollment: 693 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hospital Israelita Albert Einstein (Academic / other)
• Locations: 1 site (São Paulo, São Paulo)
• Trial ID: NCT06724315 on ClinicalTrials.gov

What this trial studies

This is a prospective, non-interventional multicenter cohort that will enroll consecutive patients with severe or very severe COPD at sites representing Brazil's geographic regions. Participants will have on-site visits at enrollment, 6 and 12 months, with telephone check-ins at 3 and 9 months, and clinical events (exacerbations, hospitalizations, cardiovascular events, deaths) will be recorded and adjudicated. Data collected will include symptom scores (CAT/CAAT), spirometry-defined severity, exacerbation history, and regional exposure factors such as tobacco, biomass, and air pollution. The goal is to identify subgroups at especially high risk who could be targets for future interventions.

Who should consider this trial

Good fit: Adults in Brazil with symptomatic severe or very severe COPD by GOLD criteria (GOLD B with mMRC≥2 or CAT≥10, GOLD E with ≥2 moderate or ≥1 severe exacerbation, or GOLD 3–4 with FEV1 <50%) who can attend study visits and telephone follow-up are ideal candidates.

Not a fit: Patients with mild or moderate COPD or those with excluded conditions (extensive interstitial lung disease >50% on HRCT, severe pulmonary hypertension on triple therapy, or active cancer receiving systemic therapy) are unlikely to benefit from this observational follow-up.

Why it matters

Potential benefit: If successful, the project could help doctors identify which patients with severe COPD are most likely to have future exacerbations or complications so care can be targeted to those at highest risk.

How similar studies have performed: Large population cohorts such as PLATINO and other longitudinal COPD cohorts have identified risk patterns for exacerbations and mortality, but tailored interventions for the highest-risk subgroups remain limited.

Eligibility criteria

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.

Where this trial is running

São Paulo, São Paulo

• Hospital Israelita Albert Einstein (HIAE) — São Paulo, São Paulo, Brazil (Recruiting)

Study contacts

• Study coordinator: Francisco JN Mazon, MD

Conditions COPD; Exacerbation; Cardiovascular; Hospitalizations; Death