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.
GOLD B (mMRC>=2, CAT>=10), OR
GOLD E (>=2 moderate exacerbations or 1 severe), OR
GOLD 3 and 4 (FEV1 <50%).
None
The population of this study will be adult patients, both sexes, with severe and very severe COPD enrolled in the participating centers.
Cohort
Prospective
Not listed
Incidence of exacerbations, hospitalizations and death.
Rate of COPD exacerbations, hospitalizations and death.
Clinical characteristics - GOLD grade (Global Intiative for Chronic Lung Disease)
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
Evolution of spirometric parameters (absolute in mL and % in relation to predicted). A higher value is better.
Clinical characteristics - BMI (Body mass index)
BMI: Body mass index (BMI - kg/m\^2). Absolute number and division \<=21 or \>21.
Incidence of exacerbations
Incidence of non-fatal cerebrovascular and cardiovascular events
Description of symptoms according to CAT score (COPD assessment test)
CAT: COPD assessment test score from 0-40, higher is more symptomatic.
Rate of decline in forced exprired volume in first second (FEV1)
Baseline to 12 months.
Click on the lead sponsor to view all of their trials.
