NCT06724315Recruiting
Prospective and Multicentric Cohort Study of Severe and Very Severe Chronic Obstructive Pulmonary Disease (COPD) in Brazil (SCOPe).
Source: ClinicalTrials.gov · Last updated 5 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 693 (estimated)
- First submitted
- 18 Nov 2024
- Start date
- 31 Jan 2025
- Primary completion date
- 15 Jul 2026
- Lead sponsor
- Hospital Israelita Albert Einstein
- Diseases
- COPD
- NCT number
- NCT06724315
What you commit to
- Study type: Observational
- Planned participants: 693
- From 31 Jan 2025 to the primary completion date, 15 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe interstitial lung disease (extent \>50% on HRCT), OR Severe pulmonary hypertension (on triple therapy), OR Active cancer - undergoing systemic therapy.
Who the study is looking for
- 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%).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Israelita Albert Einstein (HIAE) Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.