A Cross-sectional Study on COPD Prevalence

NCT03028207 | Completed

• 1 other identifier: 205932
• Study Type: observational
• Target: 9,362
• Locations: 1 country
• Sites: 20

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) is a major cause of morbidity and mortality worldwide and hence, estimating its prevalence is important. Since 2007, there are few data on the prevalence of COPD in the general population in Spain. The main objective of this epidemiological observational study is to estimate the prevalence of COPD in residents of Spain among the population over 40 years of age. The subjects will be distributed in two groups depending on the presence and absence of COPD. The study will have a single visit in which a brief interview will take place and subjects will need to complete the medical tests the case report form with a series of questionnaires. No drugs will be administered in this study.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

EPI-Scan-II Study; COPD; Epidemiology; Spain; Chronic Obstructive Pulmonary Disease; Prevalence; Cross-sectional

Outcome Measures

Primary Outcomes (1)

• Number of subjects with COPD in Spain

  The prevalence of COPD in the subjects will be calculated according to the spirometric criteria, considering that a subject has COPD when the Forced Expiratory Volume in One Second/ Forced Vital Capacity (FEV1/FVC) obtained in post-bronchodilator spirometry is less than 0.7. The prevalence of COPD according to the Global initiative for Chronic Obstructive Lung Disease (GOLD) criteria will also be evaluated.

  Up to 9 months

Secondary Outcomes (25)

• Number of COPD exacerbations

  Up to 9 months

• Analysis of differences in the prevalence of COPD and its evolution time

  Up to 9 months

• Estimation of COPD prevalence by age and sex

  Up to 9 months

• Number of subjects with comorbidities

  Up to 9 months

• Evaluation of COPD severity among subjects using the GOLD severity classification

  Up to 9 months

Study Arms (2)

COPD

Subjects with FEV1/FVC score less than 0.70 post-bronchodilator test will be allocated to COPD group and the prevalence of COPD will be evaluated. Subjects in this group will be categorized in 4 groups namely GOLD I - IV depending on the disease severity.

Procedure: Medical tests; Other: Questionnaire

Non-COPD

Subjects with FEV1/FVC score greater than or equal to 0.70 post-bronchodilator test will be allocated to non-COPD group.

Procedure: Medical tests; Other: Questionnaire

Interventions

Medical tests PROCEDURE

During Visit 1, subjects will go through medical tests including spirometry, bronchodilation test, pulse oximetry, cooximetry, and bioimpedance. Additional tests will be performed at up to 9 centers such as pulmonary diffusion test, 6 minute walk test, CT during the same visit.

COPD; Non-COPD

Questionnaire OTHER

During Visit 1, subjects will be given an Electronic Case Report Form (eCRF) with a series of questionnaire such as Health Related Quality of Life (HRQoL) CAT questionnaire, HADS anxiety scale, YPAS physical activity questionnaire, ECSC respiratory symptoms questionnaire, occupational exposure related questionnaire, MMSE questionnaire, Fagerstrom test, Prochaska test.

COPD; Non-COPD

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study population includes individuals who, after the two telephone contacts, makes the study visit with the healthcare professional in the participating site and does not present any physical or cognitive difficulties that prevent conducting any of the study tests (e.g., spirometry, questionnaires).

You may qualify if:

• Male and female subjects aged 40 years or older selected from the general population.
• Subjects who have provided oral consent to participate in the brief telephone interview; these subjects will need to sign the informed consent to continue participating in the study.

You may not qualify if:

• Subjects with any physical or cognitive difficulties which will prevent them from participating in any of the study tests (example, spirometry and questionnaires).
• Subjects who are not located, dead or displaced.

Sponsors & Collaborators

• GlaxoSmithKline: lead
• IMS Health: collaborator

Study Sites (20)

GSK Investigational Site

Avilés/Asturias, 33400, Spain

Location

GSK Investigational Site

Barcelona, 8035, Spain

Location

GSK Investigational Site

Burgos, 09006, Spain

Location

GSK Investigational Site

Cartagena (Murcia), 30202, Spain

Location

GSK Investigational Site

Cáceres, 10003, Spain

Location

GSK Investigational Site

Guadalajara, 19002, Spain

Location

GSK Investigational Site

Huesca, 22004, Spain

Location

GSK Investigational Site

La Laguna-Tenerife, 38320, Spain

Location

GSK Investigational Site

Logroño, 26006, Spain

Location

GSK Investigational Site

Madrid, 28006, Spain

Location

GSK Investigational Site

Oviedo, 33006, Spain

Location

GSK Investigational Site

Pama de Mallorca, 07010, Spain

Location

GSK Investigational Site

Pamplona, 31008, Spain

Location

GSK Investigational Site

Salamanca, 37007, Spain

Location

GSK Investigational Site

Santander, 39008, Spain

Location

GSK Investigational Site

Seville, 41009, Spain

Location

GSK Investigational Site

Valencia, 46015, Spain

Location

GSK Investigational Site

Vigo-Pontevedra, 36312, Spain

Location

GSK Investigational Site

Vitoria-Gasteiz, 01004, Spain

Location

GSK Investigational Site

Zaragoza, 50009, Spain

Location

Related Publications (2)

• Garcia-Rio F, Miravitlles M, Soriano JB, Cosio BG, Soler-Cataluna JJ, Casanova C, de Lucas P, Alfageme I, Rodriguez Gonzalez-Moro JM, Sanchez Herrero MG, Ancochea J; EPISCAN II study. Prevalence of reduced lung diffusing capacity and CT scan findings in smokers without airflow limitation: a population-based study. BMJ Open Respir Res. 2023 Jan;10(1):e001468. doi: 10.1136/bmjresp-2022-001468.

  PMID: 36707127 DERIVED

• Alfageme I, de Lucas P, Ancochea J, Miravitlles M, Soler-Cataluna JJ, Garcia-Rio F, Casanova C, Rodriguez Gonzalez-Moro JM, Cosio BG, Sanchez G, Soriano JB. 10 Years After EPISCAN: A New Study on the Prevalence of COPD in Spain -A Summary of the EPISCAN II Protocol. Arch Bronconeumol (Engl Ed). 2019 Jan;55(1):38-47. doi: 10.1016/j.arbres.2018.05.011. Epub 2018 Jul 7. English, Spanish.

  PMID: 30612602 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Surveys and Questionnaires

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)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2016
• First Posted: January 23, 2017
• Study Start: March 9, 2017
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: June 28, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (20)