Study That Will Evaluate the Brazilian Population With COPD.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

693 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-31

Study Completion Date

2027-02-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Cross-sectional Study of COPD and Symptom Variability in MEA Countries

NCT03425760

Chronic Obstructive Pulmonary Disease

COMPLETED

GOLD 0 - DLCO 1: A Look Beyond the Obstruction. Is Spirometry Enough for COPD (Chronic Obstructive Pulmonary Disease) Screening?

NCT05016466

COPD, Chronic Obstructive Pulmonary Disease

NOT_YET_RECRUITING

Observational Multicenter Non-interventional Study on COPD Patients Treatment Strategies at the Time of Hospital Discharge and Within 12 Months of Follow-up on an Outpatient Primary Care Basement

NCT02346292

COPD

COMPLETED

A Study to Evaluate the Symptoms Over 24 Hours in Patients With Chronic Obstructive Pulmonary Disease - LASSYC Study

NCT03381560

Chronic Obstructive Pulmonary Disease

COMPLETED

Predictors of Acute Exacerbation in Patients With COPD - an Observational Study

NCT04140097

Chronic Obstructive Pulmonary Disease COPD COPD Exacerbation +1 more

ACTIVE_NOT_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COPD (Chronic Obstructive Pulmonary Disease)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No