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Prevalence of Chronic Obstructive Pulmonary Disease in the Portuguese Population

Prevalence of Chronic Obstructive Pulmonary Disease in the Portuguese Population- EpiCOPDpt Study

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06523257
Acronym
EpiCOPDpt
Enrollment
8589
Registered
2024-07-26
Start date
2024-09-01
Completion date
2025-07-31
Last updated
2024-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Brief summary

The EpiCOPDpt Study (Prevalence of Chronic Obstructive Pulmonary Disease in the Portuguese Population) primary objective is to estimate the prevalence of Chronic Obstructive Pulmonary Disease (COPD) in the Portuguese population aged 20 and over. It is a cross-sectional study of a representative sample of the Portuguese population aged 20 and over, using standardised post-bronchodilator spirometry. Questionnaires will be applied to collect sociodemographic, economic, clinical, and therapeutic data.

Interventions

DIAGNOSTIC_TESTSpirometry

Spirometry is a simple test used to diagnose and monitor lung diseases by measuring how much air a person can breathe out in one forced breath. After the baseline spirometry, and only if there is clear evidence of an airflow limitation/obstruction, i.e., if the FEV1/FVC (forced expiratory volume in the first second/forced vital capacity) ratio is less than 70% or less than the 5th percentile of the distribution of values measured in the reference population, a bronchodilator test will be performed using standardised post-bronchodilator spirometry (200 µg salbutamol), in order to identify persistent airflow limitation/obstruction.

Sponsors

Sociedade Portuguesa de Pneumologia
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Male and female subjects aged 20 years and over, with permanent or temporary residence for at least one year in the national territory; * Written informed consent for study participation.

Exclusion criteria

* Any condition that makes it impossible to perform spirometry, in accordance with standards of the joint American Thoracic Society/European Respiratory Society, and as described in the Contraindications for spirometry testing section of the Study Procedures Manual; * Any condition that makes it impossible to perform the bronchodilation, as described in the Contraindications for bronchodilation section of the Study Procedures Manual; * Severe cognitive disability that may interfere with the person's capability to participate in the study.

Design outcomes

Primary

MeasureTime frameDescription
Individuals aged 20 years and over in the Portuguese population diagnosed with COPD(Chronic Obstructive Pulmonary Disease).Through study completion, an average of 10 monthsNumber and proportion of individuals aged 20 years and over in the Portuguese population diagnosed with COPD.

Secondary

MeasureTime frameDescription
Individuals aged >20 years in the Portuguese population diagnosed with COPD (Chronic Obstructive Pulmonary Disease) by sexThrough study completion, an average of 10 monthsNumber and proportion of individuals aged 20 years and over in the Portuguese population diagnosed with COPD by sex: males and females.
Individuals diagnosed with COPD (Chronic Obstructive Pulmonary Disease) in each NUTS regionThrough study completion, an average of 10 monthsNumber and proportion of individuals diagnosed with COPD in each NUTS region (Norte, Centro, Lisboa e Vale do Tejo, Alentejo, Algarve, Açores, and Madeira).
Individuals aged 20 years and over in the Portuguese population diagnosed with COPD (Chronic Obstructive Pulmonary Disease), by age groupThrough study completion, an average of 10 monthsNumber and proportion of individuals aged 20 years and over in the Portuguese population diagnosed with COPD among males and females, within specific age groups (≥20, 20-29, 30-39, 40-49, 50-59, 60-69, and ≥70).
Clinical profile of respiratory patientsThrough study completion, an average of 10 monthsA set of characteristics will be used to determine the clinical profile: * Respiratory symptoms (such as cough, shortness of breath, and wheezing) * Comorbidities (Yes, which?/No) * Lung function tests (Spirometry will be carried out in accordance with the standard protocol of the joint ATS/ERS. The US Third National Health and Nutrition Examination Survey (NHANES III) values will be used as reference. Peripheral blood oxygen saturation (SpO2) will be assessed using a pulse oximeter) * Anthropometric data: Weight in kilograms and height in meters. Weight and height will be combined to report BMI in kg/m\^2. Number and proportion in case of categorical data and means, std dev and percentiles in case of continuous variables.
Risk profile of participantsThrough study completion, an average of 10 monthsCharacterisation of risk factors, such as smoking history, occupational exposures, air pollution exposure, genetic predisposition, and history of respiratory infections. Number and proportion in case of categorical data and mean, median, standard deviation, and percentiles in case of continuous variables.
Sociodemographic profile of respiratory patientsThrough study completion, an average of 10 monthsA set of characteristics will be used to determine the sociodemographic profile: Sociodemographic characteristics: * Age * Sex * Race * Ethnicity * Marital status * Education level * Socioeconomic status (income and living conditions) Number and proportion in case of categorical data and means, std dev and percentiles in case of continuous variables.

Contacts

Primary ContactAna Barros, PhD
ana.barros@sppneumologia.pt+351915428072

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026