Study That Will Evaluate the Brazilian Population With COPD.

Recruiting

• Conditions: COPD (Chronic Obstructive Pulmonary Disease)

• Registration Number: NCT06780046
• Lead Sponsor: AstraZeneca

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.

Study Timeline

• Study First Submitted: 2025-01-13
• Study First Submitted QC: 2025-01-13
• Study First Posted: 2025-01-17
• Study Start: 2025-01-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-18
• Primary Completion: 2027-02-26
• Study Completion: 2027-02-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 693

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of hospitalizations	through study completion, an average of 1 year	Any need for hospitalization involving a hospital stay of more than 24 hours
Incidence of exacerbations	through study completion, an average of 1 year	This is an acute event, with onset within 14 days, with increased symptoms: dyspnea, cough, expectoration
Incidence of Mortality	through study completion, an average of 1 year	All deaths will be reviewed, determining the main cause of the fatal outcome.

Secondary Outcome Measures

Name	Time	Method
Incidence of vaccinated participants, with vaccines recommended by guidelines for patients with COPD	through study completion, an average of 1 year	Vaccination rate for influenza, SARS-CoV-2, pneumococcus, adult double (or acellular triple bacterial) and triple viral.
Incidence of lung neoplasia	through study completion, an average of 1 year	Results of any biopsies should be noted in the participant's medical record

Trial Locations

Locations (1)

Centro de Pesquisa Clinica do Instituto Israelita de Ensino (HIAE); 🇧🇷 Sao Paulo, Brazil