COPD (Chronic Obstructive Pulmonary Disease)
Conditions
Brief summary
Observational, prospective, multicenter cohort study with consecutive inclusion of COPD patients. Eligible patients will be those with severe and very severe COPD according to the GOLD 2024 (Global Initiative for Chronic Obstructive Lung Disease) guidelines being followed at participating hospitals. The severity of COPD is related to the exacerbation rate, which in turn is related to the progression of the disease and the occurrence of complications and death. There is no national data on this subgroup.
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) poderão ser usados intercambiavelmente. 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
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients of both sexes, aged 18 years or older, with confirmed COPD according to GOLD 2024: previous or current exposure and spirometry (FEV1/FVC =2 or CAT \>=10); or * GOLD E (\>=2 moderate or 1 severe exacerbation - hospitalization); or * GOLD 3 and 4 (FEV1 \<50%).
Exclusion criteria
* Advanced fibrosing interstitial lung disease (extent \>=50%); and/or * High-risk pulmonary hypertension (on triple therapy); and/or * Active cancer - on systemic therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hospitalizations | through study completion, an average of 1 year | Any need for hospitalization involving a hospital stay of more than 24 hours |
| Incidence of exacerbations | through study completion, an average of 1 year | This is an acute event, with onset within 14 days, with increased symptoms: dyspnea, cough, expectoration |
| Incidence of Mortality | through study completion, an average of 1 year | All deaths will be reviewed, determining the main cause of the fatal outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of vaccinated participants, with vaccines recommended by guidelines for patients with COPD | through study completion, an average of 1 year | Vaccination rate for influenza, SARS-CoV-2, pneumococcus, adult double (or acellular triple bacterial) and triple viral. |
| Incidence of lung neoplasia | through study completion, an average of 1 year | Results of any biopsies should be noted in the participant's medical record |
Countries
Brazil
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed