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NCT Number: NCT06523257

Prevalence of Chronic Obstructive Pulmonary Disease in the Portuguese Population

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Spirometry

Diagnostic Test

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.

Primary outcomes

  1. Individuals aged 20 years and over in the Portuguese population diagnosed with COPD(Chronic Obstructive Pulmonary Disease).

    Time frame: Through study completion, an average of 10 months

    Number and proportion of individuals aged 20 years and over in the Portuguese population diagnosed with COPD.

Secondary outcomes

  1. Individuals aged 20 years and over in the Portuguese population diagnosed with COPD (Chronic Obstructive Pulmonary Disease), by age group

    Time frame: Through study completion, an average of 10 months

    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).

  2. Individuals aged >20 years in the Portuguese population diagnosed with COPD (Chronic Obstructive Pulmonary Disease) by sex

    Time frame: Through study completion, an average of 10 months

    Number and proportion of individuals aged 20 years and over in the Portuguese population diagnosed with COPD by sex: males and females.

  3. Individuals diagnosed with COPD (Chronic Obstructive Pulmonary Disease) in each NUTS region

    Time frame: Through study completion, an average of 10 months

    Number and proportion of individuals diagnosed with COPD in each NUTS region (Norte, Centro, Lisboa e Vale do Tejo, Alentejo, Algarve, Açores, and Madeira).

  4. Sociodemographic profile of respiratory patients

    Time frame: Through study completion, an average of 10 months

    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.

  5. Clinical profile of respiratory patients

    Time frame: Through study completion, an average of 10 months

    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.

  6. Risk profile of participants

    Time frame: Through study completion, an average of 10 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ana Barros, PhD

CONTACT

[email protected]

+351915428072

Sponsors and collaborators

Lead sponsor

Sociedade Portuguesa de Pneumologia

Other

Registry information

Official study title

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

Acronym: EpiCOPDpt

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 26, 2024
Registry last updated
Jul 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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