Prevalence of Chronic Obstructive Pulmonary Disease in the Portuguese Population (EpiCOPDpt)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Diagnostic test: Spirometry

• Study Type: Observational
• Enrollment (Estimated): 8589

Contacts and Locations

• Study Contact: Name: Ana Barros, PhD; Phone Number: +351915428072; Email: ana.barros@sppneumologia.pt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Portuguese population aged 20 years and over.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Individuals aged 20 years and over in the Portuguese population diagnosed with COPD(Chronic Obstructive Pulmonary Disease).	Number and proportion of individuals aged 20 years and over in the Portuguese population diagnosed with COPD.	Through study completion, an average of 10 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Individuals aged 20 years and over in the Portuguese population diagnosed with COPD (Chronic Obstructive Pulmonary Disease), by age group	Number 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).	Through study completion, an average of 10 months
Individuals aged >20 years in the Portuguese population diagnosed with COPD (Chronic Obstructive Pulmonary Disease) by sex	Number and proportion of individuals aged 20 years and over in the Portuguese population diagnosed with COPD by sex: males and females.	Through study completion, an average of 10 months
Individuals diagnosed with COPD (Chronic Obstructive Pulmonary Disease) in each NUTS region	Number and proportion of individuals diagnosed with COPD in each NUTS region (Norte, Centro, Lisboa e Vale do Tejo, Alentejo, Algarve, Açores, and Madeira).	Through study completion, an average of 10 months
Sociodemographic profile of respiratory patients	A 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.	Through study completion, an average of 10 months
Clinical profile of respiratory patients	A 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.	Through study completion, an average of 10 months
Risk profile of participants	Characterisation 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.	Through study completion, an average of 10 months

Collaborators and Investigators

• Sponsor: Sociedade Portuguesa de Pneumologia

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: July 16, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): July 26, 2024
• Last Update Submitted That Met QC Criteria: July 22, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2023_EO_EPICOPDPT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No