An observational study in COPD (Chronic Obstructive Pulmonary Disease), sponsored by Hospital Israelita Albert Einstein. Recruiting at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-05.
Sponsored by Hospital Israelita Albert Einstein · Observational
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.
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.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 693 is above the median of 158 across 1,497 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Hospital Israelita Albert Einstein is the lead sponsor of 147 studies on the registry; 32 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The population of this study will be adult patients, both sexes, with severe and very severe COPD enrolled in the participating centers.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Severe, very severe and symptomaitc , according to GOLD definition: exposure, /FVC ratio \<0,7:
Exclusion Criteria:
Severe interstitial lung disease (extent >50% on HRCT), OR Severe pulmonary hypertension (on triple therapy), OR Active cancer - undergoing systemic therapy.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Criteria: CAT ≥10 or MMRC ≥ 2 ; OR 2 exacerbations/year or 1 exacerbation leading to hospitalization
Criteria: FVE1 \< 50%
Incidence of exacerbations, hospitalizations and death.
Rate of COPD exacerbations, hospitalizations and death.
Time frame: 12 months
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),
Time frame: 12 months
Clinical characteristics - spirometric parameters
Evolution of spirometric parameters (absolute in mL and % in relation to predicted). A higher value is better.
Time frame: 12 months
Clinical characteristics - BMI (Body mass index)
BMI: Body mass index (BMI - kg/m\^2). Absolute number and division \<=21 or \>21.
Time frame: 12 months
Incidence of exacerbations
Time frame: 12 months
Incidence of non-fatal cerebrovascular and cardiovascular events
Time frame: 12 months
Description of symptoms according to CAT score (COPD assessment test)
CAT: COPD assessment test score from 0-40, higher is more symptomatic.
Time frame: 12 months
Rate of decline in forced exprired volume in first second (FEV1)
Baseline to 12 months.
Time frame: 12 months
Description of quality of life score SGRQ-C (St. George Respiratory Questionaire - COPD)
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.
Time frame: 12 months
Description of symptoms according to mMRC (Modified Medical Research Council dyspnea scale)
mMRC: Modified Medical Research Council (dyspnea scale) 0-4, higher is worse
Time frame: 12 months
Description of symptoms 6MWT (6 minutes walk test)
6MWT: 6 minutes walk test (meters) 0-1000m, above 1000m is highly improbable, higher is better.
Time frame: 12 months
Description of treatment
Description of medication classes and dosages in use.
Time frame: 12 months
Clinical characteristics - laboratory data
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).
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2025 (actual). Primary completion is estimated for Jul 2026, 17 months after the start.
Of 466 non-industry observational studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 64. This study's planned 17 months is below that.
Counting every sponsor, half of 586 studies reached it within 26 months; a quarter within 14 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
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