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New Study on the Prevalence of COPD in Spain EPI-Scan-II Study (NCT03028207)

IMS Health
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.
  • Procedure: 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.
    • Other: 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.
      Ages eligible for Study
      40 Years and older
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      Inclusion Criteria:
      • 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.
      Exclusion Criteria:
      • 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.

      1 locations

      Spain (1)
      • GSK Investigational Site
        recruiting
        Madrid, Spain, 28006
      Status:
      recruiting
      Type:
      Observational
      Phase:
      -
      Start:
      23 March, 2017
      Updated:
      20 April, 2017
      Participants:
      10200
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