Prevalence of Chronic Obstructive Pulmonary Disease in the Portuguese Population

NCT ID: NCT06523257

Last Updated: 2024-07-26

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

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

8589 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-01

Study Completion Date

2025-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Spirometry

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sociedade Portuguesa de Pneumologia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Ana Barros, PhD

Role: CONTACT

+351915428072

Other Identifiers

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2023_EO_EPICOPDPT

Identifier Type: -

Identifier Source: org_study_id

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