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NCT Number: NCT06724315

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

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.

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Key information

Conditions

COPD (Chronic Obstructive Pulmonary Disease) Chronic Disease Death 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

Hospital Israelita Albert Einstein (HIAE)

São Paulo, 05652-900, Brazil

Location status: Recruiting

Location contact

Francisco J N Mazon, MD

CONTACT

[email protected]

+55 11 21511233

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).

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

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.

Treatment and study plan

Primary outcomes

  1. Incidence of exacerbations, hospitalizations and death.

    Time frame: 12 months

    Rate of COPD exacerbations, hospitalizations and death.

Secondary outcomes

  1. Clinical characteristics - GOLD grade (Global Intiative for Chronic Lung Disease)

    Time frame: 12 months

    Baseline and evolution of numeric and percentual data of the clinical characteristics: GOLD grade: Global Intiative for Chronic Lung Disease according to the 2024 guidelines (ABE, 1-4),

  2. Clinical characteristics - spirometric parameters

    Time frame: 12 months

    Evolution of spirometric parameters (absolute in mL and % in relation to predicted). A higher value is better.

  3. Clinical characteristics - BMI (Body mass index)

    Time frame: 12 months

    BMI: Body mass index (BMI - kg/m^2). Absolute number and division <=21 or >21.

Other outcomes

  1. Incidence of exacerbations

    Time frame: 12 months

  2. Incidence of non-fatal cerebrovascular and cardiovascular events

    Time frame: 12 months

  3. Description of symptoms according to CAT score (COPD assessment test)

    Time frame: 12 months

    CAT: COPD assessment test score from 0-40, higher is more symptomatic.

  4. Rate of decline in forced exprired volume in first second (FEV1)

    Time frame: 12 months

    Baseline to 12 months.

  5. Description of quality of life score SGRQ-C (St. George Respiratory Questionaire - COPD)

    Time frame: 12 months

    SGRQ-C: St. George Respiratory Questionaire - COPD. The Total score is calculated by summing the weights to all the positive responses in each component. Score ranges from 0 to a Total (sum of maximum for all three components) 3201.9. Higher score is worse.

  6. Description of symptoms according to mMRC (Modified Medical Research Council dyspnea scale)

    Time frame: 12 months

    mMRC: Modified Medical Research Council (dyspnea scale) 0-4, higher is worse

  7. Description of symptoms 6MWT (6 minutes walk test)

    Time frame: 12 months

    6MWT: 6 minutes walk test (meters) 0-1000m, above 1000m is highly improbable, higher is better.

  8. Description of treatment

    Time frame: 12 months

    Description of medication classes and dosages in use.

  9. Clinical characteristics - laboratory data

    Time frame: 12 months

    Recent laboratory data will be analyzed and collected when available (e.g., eosinophils absolute count/mcL and %, IgE KU/L, chest CT report in pdf).

Study contacts

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

Francisco JN Mazon, MD

CONTACT

[email protected]

+55 11 21511233

Henrique A R Fonseca, ScD

CONTACT

[email protected]

+55 11 21511233

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Registry information

Acronym: SCOPe

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2024
Registry last updated
Jun 5, 2025

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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