Clinical trial NCT06724315: Prospective and Multicentric Cohort Study of Severe and Very Severe Chronic Obstructive Pulmonary Disease (COPD) in Brazil (SCOPe).
Official title: Prospective and Multicentric Cohort Study of Severe and Very Severe Chronic Obstructive Pulmonary Disease (COPD) in Brazil (SCOPe).
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COPD (Chronic Obstructive Pulmonary Disease)
Keywords: COPD; Exacerbation; Cardiovascular; Hospitalizations; Death;
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 693
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population of this study will be adult patients, both sexes, with severe and very severe COPD enrolled in the participating centers.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of exacerbations, hospitalizations and death.
timeFrame: 12 months
Secondary outcomes:
measure: Clinical characteristics - GOLD grade (Global Intiative for Chronic Lung Disease)
timeFrame: 12 months
measure: Clinical characteristics - spirometric parameters
timeFrame: 12 months
measure: Clinical characteristics - BMI (Body mass index)
timeFrame: 12 months
Other outcomes:
measure: Incidence of exacerbations
timeFrame: 12 months
measure: Incidence of non-fatal cerebrovascular and cardiovascular events
timeFrame: 12 months
measure: Description of symptoms according to CAT score (COPD assessment test)
timeFrame: 12 months
measure: Rate of decline in forced exprired volume in first second (FEV1)
timeFrame: 12 months
measure: Description of quality of life score SGRQ-C (St. George Respiratory Questionaire - COPD)
timeFrame: 12 months
measure: Description of symptoms according to mMRC (Modified Medical Research Council dyspnea scale)
timeFrame: 12 months
measure: Description of symptoms 6MWT (6 minutes walk test)
timeFrame: 12 months
measure: Description of treatment
timeFrame: 12 months
measure: Clinical characteristics - laboratory data
timeFrame: 12 months
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein (HIAE)
state: SP
Study officials:
affiliation: Hospital Albert Einstein
name: Henrique AR Fonseca, ScD
role: STUDY_CHAIR
References: