Prevalence of Chronic Obstructive Pulmonary Disease in the Portuguese Population

NCT06523257 | Not Yet Recruiting DMC

• 1 other identifier: 2023_EO_EPICOPDPT
• Study Type: observational
• Target: 8,589
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

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

  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

  Through study completion, an average of 10 months

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

  Through study completion, an average of 10 months

• Sociodemographic profile of respiratory patients

  Through study completion, an average of 10 months

• Clinical profile of respiratory patients

  Through study completion, an average of 10 months

Interventions

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.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Portuguese population aged 20 years and over.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sociedade Portuguesa de Pneumologia: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Spirometry

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Ana Barros, PhD

CONTACT

+351915428072; ana.barros@sppneumologia.pt

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 26, 2024
• Study Start: September 1, 2024
• Primary Completion: January 31, 2025
• Study Completion: July 31, 2025
• Last Updated: July 26, 2024

Record last verified: 2024-07