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NCT Number: NCT06780046

Study That Will Evaluate the Brazilian Population With COPD.

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.

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Key information

Conditions

COPD (Chronic Obstructive Pulmonary Disease) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Aparecida de Goiânia, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of hospitalizations

    Time frame: through study completion, an average of 1 year

    Any need for hospitalization involving a hospital stay of more than 24 hours

  2. Incidence of exacerbations

    Time frame: through study completion, an average of 1 year

    This is an acute event, with onset within 14 days, with increased symptoms: dyspnea, cough, expectoration

  3. Incidence of Mortality

    Time frame: through study completion, an average of 1 year

    All deaths will be reviewed, determining the main cause of the fatal outcome.

Secondary outcomes

  1. Incidence of vaccinated participants, with vaccines recommended by guidelines for patients with COPD

    Time frame: 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.

  2. Incidence of lung neoplasia

    Time frame: through study completion, an average of 1 year

    Results of any biopsies should be noted in the participant's medical record

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Prospective Multicentric Cohort Study of Severe and Very Severe COPD Patients in Brazil.

Acronym: SCOPe

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 17, 2025
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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