Evaluating COPD in the Brazilian population
Prospective Multicentric Cohort Study of Severe and Very Severe COPD Patients in Brazil.
This study is trying to learn more about how severe COPD affects people in different parts of Brazil by following patients for a year to see how their condition changes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 693 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Locations | 10 sites (Aparecida de Goiânia and 9 other locations) |
| Trial ID | NCT06780046 on ClinicalTrials.gov |
What this trial studies
This observational, prospective, multicenter cohort study aims to include patients with severe and very severe Chronic Obstructive Pulmonary Disease (COPD) according to the GOLD 2024 guidelines. The study will enroll patients from various regions of Brazil, each with different risk factors and population characteristics, to gather comprehensive data on COPD exacerbation rates and disease progression. Participants will be followed for 12 months with on-site visits and tele-consults to monitor their condition and collect relevant clinical data.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with confirmed severe or very severe COPD.
Not a fit: Patients with advanced fibrosing interstitial lung disease, high-risk pulmonary hypertension, or active cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the management and treatment of severe COPD in the Brazilian population.
How similar studies have performed: While this study focuses on a specific population in Brazil, similar observational studies have shown success in understanding COPD in diverse populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Aparecida de Goiânia and 9 other locations
- Research Site — Aparecida de Goiânia, Brazil (Recruiting)
- Research Site — Bahia, Brazil (Recruiting)
- Research Site — Belém, Brazil (Recruiting)
- Research Site — Brasília, Brazil (Recruiting)
- Research Site — Campo Grande, Brazil (Recruiting)
- Research Site — Florianópolis, Brazil (Not_yet_recruiting)
- Research Site — Goiânia, Brazil (Recruiting)
- Research Site — Santo André, Brazil (Recruiting)
- Research Site — São Paulo, Brazil (Recruiting)
- Research Site — Uberlândia, Brazil (Not_yet_recruiting)
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.