Study That Will Evaluate the Brazilian Population With COPD.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAstraZeneca
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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%).
Disqualifiers
Advanced fibrosing interstitial lung disease (extent >=50%); and/or
High-risk pulmonary hypertension (on triple therapy); and/or
Active cancer - on systemic therapy
Trial population
Adults of both sexes with severe and very severe COPD being followed up at participating centers - referral hospitals distributed throughout the country. There are plans to include 693 patients from GOLD B, E, 3 and 4, who will be followed up for 12 months.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Incidence of hospitalizations
Any need for hospitalization involving a hospital stay of more than 24 hours
Time frame
through study completion, an average of 1 year2
Incidence of exacerbations
This is an acute event, with onset within 14 days, with increased symptoms: dyspnea, cough, expectoration
Time frame
through study completion, an average of 1 year3
Incidence of Mortality
All deaths will be reviewed, determining the main cause of the fatal outcome.
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
Incidence of vaccinated participants, with vaccines recommended by guidelines for patients with COPD
Vaccination rate for influenza, SARS-CoV-2, pneumococcus, adult double (or acellular triple bacterial) and triple viral.
Time frame
through study completion, an average of 1 year2
Incidence of lung neoplasia
Results of any biopsies should be noted in the participant's medical record
Time frame
through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov