Clinical trial NCT06780046: Study That Will Evaluate the Brazilian Population With COPD.
Official title: Prospective Multicentric Cohort Study of Severe and Very Severe COPD Patients in Brazil.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COPD (Chronic Obstructive Pulmonary Disease)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2025-01-17
Enrollment: 693
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults of both sexes with severe and very severe COPD being followed up at participating centers - referral hospitals distributed throughout the country. There are plans to include 693 patients from GOLD B, E, 3 and 4, who will be followed up for 12 months.

Brief summary: Observational, prospective, multicenter cohort study with consecutive inclusion of COPD patients. Eligible patients will be those with severe and very severe COPD according to the GOLD 2024 (Global Initiative for Chronic Obstructive Lung Disease) guidelines being followed at participating hospitals. The severity of COPD is related to the exacerbation rate, which in turn is related to the progression of the disease and the occurrence of complications and death. There is no national data on this subgroup.

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) poderão ser usados intercambiavelmente. 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.

Eligibility criteria: Inclusion Criteria:

* Patients of both sexes, aged 18 years or older, with confirmed COPD according to GOLD 2024: previous or current exposure and spirometry (FEV1/FVC =2 or CAT \>=10); or
* GOLD E (\>=2 moderate or 1 severe exacerbation - hospitalization); or
* GOLD 3 and 4 (FEV1 \<50%).

Exclusion Criteria:

* Advanced fibrosing interstitial lung disease (extent \>=50%); and/or
* High-risk pulmonary hypertension (on triple therapy); and/or
* Active cancer - on systemic therapy

Primary outcomes:
measure: Incidence of hospitalizations
timeFrame: through study completion, an average of 1 year
measure: Incidence of exacerbations
timeFrame: through study completion, an average of 1 year
measure: Incidence of Mortality
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Incidence of vaccinated participants, with vaccines recommended by guidelines for patients with COPD
timeFrame: through study completion, an average of 1 year
measure: Incidence of lung neoplasia
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Centro de Pesquisa Clinica do Instituto Israelita de Ensino (HIAE)
Study officials:
References: