COPD (Chronic Obstructive Pulmonary Disease)
Conditions
Keywords
COPD; Exacerbation; Cardiovascular; Hospitalizations; Death;
Brief summary
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.
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). 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.
Interventions
None listed
Sponsors
Hospital Israelita Albert Einstein
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of exacerbations, hospitalizations and death. | 12 months | Rate of COPD exacerbations, hospitalizations and death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical characteristics - GOLD grade (Global Intiative for Chronic Lung Disease) | 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), |
| Clinical characteristics - spirometric parameters | 12 months | Evolution of spirometric parameters (absolute in mL and % in relation to predicted). A higher value is better. |
| Clinical characteristics - BMI (Body mass index) | 12 months | BMI: Body mass index (BMI - kg/m\^2). Absolute number and division \<=21 or \>21. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Description of symptoms according to CAT score (COPD assessment test) | 12 months | CAT: COPD assessment test score from 0-40, higher is more symptomatic. |
| Rate of decline in forced exprired volume in first second (FEV1) | 12 months | Baseline to 12 months. |
| Description of treatment | 12 months | Description of medication classes and dosages in use. |
| Description of symptoms according to mMRC (Modified Medical Research Council dyspnea scale) | 12 months | mMRC: Modified Medical Research Council (dyspnea scale) 0-4, higher is worse |
| Description of symptoms 6MWT (6 minutes walk test) | 12 months | 6MWT: 6 minutes walk test (meters) 0-1000m, above 1000m is highly improbable, higher is better. |
| Description of quality of life score SGRQ-C (St. George Respiratory Questionaire - COPD) | 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. |
| Clinical characteristics - laboratory data | 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). |
| Incidence of exacerbations | 12 months | — |
| Incidence of non-fatal cerebrovascular and cardiovascular events | 12 months | — |
Countries
Brazil
Contacts
Primary ContactFrancisco JN Mazon, MD
Backup ContactHenrique A R Fonseca, ScD
Outcome results
None listed