Study Results
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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COMPLETED
9362 participants
OBSERVATIONAL
2017-03-09
2019-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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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.
Medical tests
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.
Questionnaire
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.
Non-COPD
Subjects with FEV1/FVC score greater than or equal to 0.70 post-bronchodilator test will be allocated to non-COPD group.
Medical tests
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.
Questionnaire
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.
Interventions
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Medical tests
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.
Questionnaire
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Subjects who are not located, dead or displaced.
40 Years
ALL
No
Sponsors
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IMS Health
OTHER
GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Avilés/Asturias, , Spain
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Burgos, , Spain
GSK Investigational Site
Cartagena (Murcia), , Spain
GSK Investigational Site
Cáceres, , Spain
GSK Investigational Site
Guadalajara, , Spain
GSK Investigational Site
Huesca, , Spain
GSK Investigational Site
La Laguna-Tenerife, , Spain
GSK Investigational Site
Logroño, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Oviedo, , Spain
GSK Investigational Site
Pama de Mallorca, , Spain
GSK Investigational Site
Pamplona, , Spain
GSK Investigational Site
Salamanca, , Spain
GSK Investigational Site
Santander, , Spain
GSK Investigational Site
Seville, , Spain
GSK Investigational Site
Valencia, , Spain
GSK Investigational Site
Vigo-Pontevedra, , Spain
GSK Investigational Site
Vitoria-Gasteiz, , Spain
GSK Investigational Site
Zaragoza, , Spain
Countries
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References
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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.
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.
Other Identifiers
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205932
Identifier Type: -
Identifier Source: org_study_id
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