<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03028207</url>
  </required_header>
  <id_info>
    <org_study_id>205932</org_study_id>
    <nct_id>NCT03028207</nct_id>
  </id_info>
  <brief_title>A Cross-sectional Study on COPD Prevalence</brief_title>
  <official_title>New Study on the Prevalence of COPD in Spain EPI-Scan-II Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>IMS Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic Obstructive Pulmonary Disease (COPD) is a major cause of morbidity and mortality&#xD;
      worldwide and hence, estimating its prevalence is important. Since 2007, there are few data&#xD;
      on the prevalence of COPD in the general population in Spain. The main objective of this&#xD;
      epidemiological observational study is to estimate the prevalence of COPD in residents of&#xD;
      Spain among the population over 40 years of age. The subjects will be distributed in two&#xD;
      groups depending on the presence and absence of COPD. The study will have a single visit in&#xD;
      which a brief interview will take place and subjects will need to complete the medical tests&#xD;
      the case report form with a series of questionnaires. No drugs will be administered in this&#xD;
      study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 9, 2017</start_date>
  <completion_date type="Actual">March 1, 2019</completion_date>
  <primary_completion_date type="Actual">March 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects with COPD in Spain</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of COPD exacerbations</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>The No. and type of COPD exacerbations in the past year will be described. Depending on the frequency, the subjects will be grouped into two categories: less than two exacerbations per year and two or more exacerbations per year.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of differences in the prevalence of COPD and its evolution time</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>Previous studies such as IBERPOC or EPISCAN will be analyzed to compare differences in the prevalence of COPD and its evolution over time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimation of COPD prevalence by age and sex</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>Subjects in COPD cohort will be classified according to sex and age groups, and the association between prevalence and age will be explored from the chi-squared test and linear-by-linear association. The prevalence of COPD in different age and sex groups will be compared according to the FEV1/FVC ratio.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with comorbidities</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>Presence of comorbidities among subjects with and without COPD will be evaluated using the Charlson and COPD speciﬁc comorbidity test (COTE indices), which associate long-term mortality with subject comorbidity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of COPD severity among subjects using the GOLD severity classification</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>COPD severity according to GOLD criteria will be evaluated from the results of FEV1/FVC from the post-bronchodilator test. Subjects will be classified into 4 groups namely GOLD 1, GOLD 2, GOLD 3 and GOLD 4 for COPD severity with GOLD 1= mild and GOLD 4 = very severe COPD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of distribution of subjects according to Spanish COPD Guide (GesEPOC)</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>Subjects will be distributed based on GesEPOC into 4 phenotypes that determine differential treatment: non-exacerbator; mixed COPD-asthma; exacerbator with emphysema and exacerbator with chronic bronchitis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of the risk factors of COPD</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>The risk factors of COPD including level of physical activity, degree of smoking, occupational exposure and exposure to smoke from biomass combustion will be analyzed in COPD cohort.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of relationship between the diagnosis of COPD, symptoms, level of physical activity and smoking status</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>The relationship between the diagnosis of COPD, the level of physical activity and smoking will be assessed first by describing physical activity and smoking based on study cohorts. In the subpopulation of subjects who are smokers, the score on the Fagerstrom Test calculated as the sum of the 6 items (0-10) will be described and it will also be categorized as follows: mild dependency (0-2), medium dependency (3-5) and high dependency (6-10), as well as the smoking cessation phase in which they are, as assessed by Prochaska's stage: pre-contemplation, contemplation, preparation, action, maintenance, termination and relapse.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of treatment received according to current guideline</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>It will be assessed whether treatment received in the study's COPD population complies with current regulations. The rate of undertreatment and overtreatment in subjects with COPD will also be evaluated. The percentage of COPD subjects who are treated according to the provisions of GesEPOC and according to GOLD will be compared in a post hoc analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with smoking habit</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>The prevalence of smoking and electronic cigarette use in people of 40 years of age or older in Spain and by sex will be described.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of nicotine dependence among subjects</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>The level of nicotine dependence among smokers will be assessed using Fagerstrom test. The test will consist of 6 items and the final score will range from 0- 10 with higher score correlating with higher nicotine dependency. The phase of smoking cessation of subjects will also be assessed using the Prochaska's test. In this test, 3 questions will be asked to each subject. It will identify the smoker's time of addiction to tobacco based on a series of set stages: pre-contemplation, contemplation, preparation, action and maintenance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with respiratory symptoms</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>The presence and prevalence of specific respiratory symptoms such as chronic cough, dyspnea will be estimated using the European Coal and Steel Community (ECSC) respiratory symptoms questionnaire. The questions will be divided into 6 sections namely cough, expectoration, dyspnea, wheezing and intra-thoracic pressure, asthma attacks and treatments.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate Health Related Quality of Life (HRQoL) of subjects</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>HRQoL will be evaluated by using the COPD Assessment Test (CAT) questionnaire. It will consist of a single dimension with 8 items, each with a response scale of 0 (no limitation) to 5 (very limited). The items will assess the degree of severity of cough, presence of mucus, chest pressure, dyspnea, limited domestic activities, social limitations and limited sleep and energy. The overall score will be described in a range of 0-40 points and will distribute subjects into two groups including CAT less than 10 (low impact of COPD) and CAT more than or equal to 10 (medium/high impact of COPD on the subject).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with possible cognitive impairment</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>Possible cognitive impairment will be evaluated in subjects 60 years of age or older using mini-mental state examination (MMSE) questionnaire. It is a rapid screening test for dementia and its evolutionary staging. The test consists of 30 items and will explore five cognitive areas: orientation, fixation, concentration and calculation, memory and language. The total score will range from 0 to 30 points. If the score falls between 0-22, the subject will be considered to have a cognitive deficit and those achieving score from 23-30 will be concluded as subjects without a cognitive deficit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with anxiety/depression</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>The presence of anxiety and depression among the subjects will be assessed using the Hospital Anxiety and Depression Scale (HADS). The HADS has two components that include scores for anxiety and depression. The response options are Likert-type, ranging from zero to three, giving a scoring range of 0-21 each. Depending on the HADS score, the subjects will be divided into 3 categories HADS 0-7 (absence of clinically relevant anxiety and/or depression), HADS 8-10 (likely to require consideration), HADS 11-21 (presence of anxiety/ depression relevant symptoms).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of lean mass index among subjects</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>The percentage of lean mass index will be evaluated and compared between COPD and non-COPD subjects by using bioimpedance. Body composition will be measured based on the electrical properties of biological tissues.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of exercise tolerance among subjects</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>Exercise tolerance between COPD and non-COPD subjects will be evaluated with the help of 6 minute walk test. The distance in meters and the reason for the stop will be measured, along with the initial and final heart rate and initial and final saturation of oxyhemoglobin (SatO2).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate daily physical activity of subjects</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>The daily physical activity of COPD and non-COPD subjects will be compared using the Yale Physical Activity Survey (YPAS) questionnaire. YPAS will be calculated as the sum of the 5 sub-indices: index of vigorous activity, easy stroll index, moving index, standing index and sitting index. This index will range from 0 to 137 points. The subjects will be categorized into two groups namely YPAS less than 51 (sedentary subjects) and YPAS more than or equal to 51 (not sedentary subjects).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recording of age</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>Age will be recorded for descriptive analysis of the sociodemographic characteristics of the subjects participating in this study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with different sociodemographic characteristics</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>No. of subjects with different education level, gender, marital and smoking status will be recorded for descriptive analysis of the sociodemographic characteristics of the subjects participating in this study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recording of body mass index (BMI)</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>BMI will be recorded for descriptive analysis of the sociodemographic characteristics of the subjects participating in this study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of instances of underdiagnosis and overdiagnosis of COPD in subjects</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>No. of instances of underdiagnosis will be described in the subsample of subjects who, despite declaring they had never received a previous diagnosis of COPD, reflect the presence of the disease from the study results. Also, the no. of instances of overdiagnosis will be described among those who claim having a prior diagnosis of COPD but who show this diagnosis to be unconfirmed after the study results. The correlation between the two variables will be analyzed using the Kappa index.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with abnormal multidimensional assessment of COPD</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>No. of subjects with abnormal BMI, airflow Obstruction, Dyspnea and Exercise capacity (BODE) index ranging from 0-10 points and BMI, degree of dyspnea, pulmonary function and severe exacerbation (BODEX) index ranging from 0- 9 points will be recorded during multidimensional assessment of COPD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with abnormal density of lung attenuation and thickness of airway caliber</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>No. of subjects with attenuation of the lung parenchyma and thickness of the wall of the airway will be determined with the help of computed tomography (CT). No. of subjects with other abnormal parameters including the percentage of emphysema, extension areas, thickness of the airway, volume of the chest muscles, diameter of aorta vs. pulmonary artery, air trapping or coronary calcifications, bronchiectasis and fibrosis will also be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with dyspnea and other respiratory symptoms, health-related quality of life, exercise tolerance, physical activity and systemic inflammation among COPD and non-COPD subjects</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>No. of subjects with intensity of dyspnea and other respiratory symptoms, health-related quality of life, exercise tolerance, physical activity and systemic inflammation will be assessed and compared between the COPD and non-COPD subjects depending on the amount of diffusion lung capacity.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">9362</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <arm_group>
    <arm_group_label>COPD</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-COPD</arm_group_label>
    <description>Subjects with FEV1/FVC score greater than or equal to 0.70 post-bronchodilator test will be allocated to non-COPD group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Medical tests</intervention_name>
    <description>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.</description>
    <arm_group_label>COPD</arm_group_label>
    <arm_group_label>Non-COPD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>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.</description>
    <arm_group_label>COPD</arm_group_label>
    <arm_group_label>Non-COPD</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Study population includes individuals who, after the two telephone contacts, makes the&#xD;
        study visit with the healthcare professional in the participating site and does not present&#xD;
        any physical or cognitive difficulties that prevent conducting any of the study tests&#xD;
        (e.g., spirometry, questionnaires).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female subjects aged 40 years or older selected from the general population.&#xD;
&#xD;
          -  Subjects who have provided oral consent to participate in the brief telephone&#xD;
             interview; these subjects will need to sign the informed consent to continue&#xD;
             participating in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with any physical or cognitive difficulties which will prevent them from&#xD;
             participating in any of the study tests (example, spirometry and questionnaires).&#xD;
&#xD;
          -  Subjects who are not located, dead or displaced.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Avilés/Asturias</city>
        <zip>33400</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Barcelona</city>
        <zip>8035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Burgos</city>
        <zip>09006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Caceres</city>
        <zip>10003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cartagena (Murcia)</city>
        <zip>30202</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Guadalajara</city>
        <zip>19002</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Huesca</city>
        <zip>22004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>La Laguna-Tenerife</city>
        <zip>38320</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Logroño</city>
        <zip>26006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Oviedo</city>
        <zip>33006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Pama de Mallorca</city>
        <zip>07010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Pamplona</city>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Salamanca</city>
        <zip>37007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Santander</city>
        <zip>39008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sevilla</city>
        <zip>41009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Valencia</city>
        <zip>46015</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Vigo-Pontevedra</city>
        <zip>36312</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Vitoria</city>
        <zip>01004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>June 26, 2019</last_update_submitted>
  <last_update_submitted_qc>June 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>EPI-Scan-II Study</keyword>
  <keyword>COPD</keyword>
  <keyword>Epidemiology</keyword>
  <keyword>Spain</keyword>
  <keyword>Chronic Obstructive Pulmonary Disease</keyword>
  <keyword>Prevalence</keyword>
  <keyword>Cross-sectional</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03028207
org study id: 205932
nct id: NCT03028207
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Cohort
time perspective: Cross-Sectional
measure: Number of subjects with COPD in Spain
time frame: Up to 9 months
description: 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.
measure: Number of COPD exacerbations
time frame: Up to 9 months
description: The No. and type of COPD exacerbations in the past year will be described. Depending on the frequency, the subjects will be grouped into two categories: less than two exacerbations per year and two or more exacerbations per year.
measure: Analysis of differences in the prevalence of COPD and its evolution time
time frame: Up to 9 months
description: Previous studies such as IBERPOC or EPISCAN will be analyzed to compare differences in the prevalence of COPD and its evolution over time.
measure: Estimation of COPD prevalence by age and sex
time frame: Up to 9 months
description: Subjects in COPD cohort will be classified according to sex and age groups, and the association between prevalence and age will be explored from the chi-squared test and linear-by-linear association. The prevalence of COPD in different age and sex groups will be compared according to the FEV1/FVC ratio.
measure: Number of subjects with comorbidities
time frame: Up to 9 months
description: Presence of comorbidities among subjects with and without COPD will be evaluated using the Charlson and COPD speciﬁc comorbidity test (COTE indices), which associate long-term mortality with subject comorbidity.
measure: Evaluation of COPD severity among subjects using the GOLD severity classification
time frame: Up to 9 months
description: COPD severity according to GOLD criteria will be evaluated from the results of FEV1/FVC from the post-bronchodilator test. Subjects will be classified into 4 groups namely GOLD 1, GOLD 2, GOLD 3 and GOLD 4 for COPD severity with GOLD 1= mild and GOLD 4 = very severe COPD.
measure: Analysis of distribution of subjects according to Spanish COPD Guide (GesEPOC)
time frame: Up to 9 months
description: Subjects will be distributed based on GesEPOC into 4 phenotypes that determine differential treatment: non-exacerbator; mixed COPD-asthma; exacerbator with emphysema and exacerbator with chronic bronchitis.
measure: Analysis of the risk factors of COPD
time frame: Up to 9 months
description: The risk factors of COPD including level of physical activity, degree of smoking, occupational exposure and exposure to smoke from biomass combustion will be analyzed in COPD cohort.
measure: Assessment of relationship between the diagnosis of COPD, symptoms, level of physical activity and smoking status
time frame: Up to 9 months
description: The relationship between the diagnosis of COPD, the level of physical activity and smoking will be assessed first by describing physical activity and smoking based on study cohorts. In the subpopulation of subjects who are smokers, the score on the Fagerstrom Test calculated as the sum of the 6 items (0-10) will be described and it will also be categorized as follows: mild dependency (0-2), medium dependency (3-5) and high dependency (6-10), as well as the smoking cessation phase in which they are, as assessed by Prochaska's stage: pre-contemplation, contemplation, preparation, action, maintenance, termination and relapse.
measure: Assessment of treatment received according to current guideline
time frame: Up to 9 months
description: It will be assessed whether treatment received in the study's COPD population complies with current regulations. The rate of undertreatment and overtreatment in subjects with COPD will also be evaluated. The percentage of COPD subjects who are treated according to the provisions of GesEPOC and according to GOLD will be compared in a post hoc analysis.
measure: Number of subjects with smoking habit
time frame: Up to 9 months
description: The prevalence of smoking and electronic cigarette use in people of 40 years of age or older in Spain and by sex will be described.
measure: Degree of nicotine dependence among subjects
time frame: Up to 9 months
description: The level of nicotine dependence among smokers will be assessed using Fagerstrom test. The test will consist of 6 items and the final score will range from 0- 10 with higher score correlating with higher nicotine dependency. The phase of smoking cessation of subjects will also be assessed using the Prochaska's test. In this test, 3 questions will be asked to each subject. It will identify the smoker's time of addiction to tobacco based on a series of set stages: pre-contemplation, contemplation, preparation, action and maintenance.
measure: Number of subjects with respiratory symptoms
time frame: Up to 9 months
description: The presence and prevalence of specific respiratory symptoms such as chronic cough, dyspnea will be estimated using the European Coal and Steel Community (ECSC) respiratory symptoms questionnaire. The questions will be divided into 6 sections namely cough, expectoration, dyspnea, wheezing and intra-thoracic pressure, asthma attacks and treatments.
measure: To evaluate Health Related Quality of Life (HRQoL) of subjects
time frame: Up to 9 months
description: HRQoL will be evaluated by using the COPD Assessment Test (CAT) questionnaire. It will consist of a single dimension with 8 items, each with a response scale of 0 (no limitation) to 5 (very limited). The items will assess the degree of severity of cough, presence of mucus, chest pressure, dyspnea, limited domestic activities, social limitations and limited sleep and energy. The overall score will be described in a range of 0-40 points and will distribute subjects into two groups including CAT less than 10 (low impact of COPD) and CAT more than or equal to 10 (medium/high impact of COPD on the subject).
measure: Number of subjects with possible cognitive impairment
time frame: Up to 9 months
description: Possible cognitive impairment will be evaluated in subjects 60 years of age or older using mini-mental state examination (MMSE) questionnaire. It is a rapid screening test for dementia and its evolutionary staging. The test consists of 30 items and will explore five cognitive areas: orientation, fixation, concentration and calculation, memory and language. The total score will range from 0 to 30 points. If the score falls between 0-22, the subject will be considered to have a cognitive deficit and those achieving score from 23-30 will be concluded as subjects without a cognitive deficit.
measure: Number of subjects with anxiety/depression
time frame: Up to 9 months
description: The presence of anxiety and depression among the subjects will be assessed using the Hospital Anxiety and Depression Scale (HADS). The HADS has two components that include scores for anxiety and depression. The response options are Likert-type, ranging from zero to three, giving a scoring range of 0-21 each. Depending on the HADS score, the subjects will be divided into 3 categories HADS 0-7 (absence of clinically relevant anxiety and/or depression), HADS 8-10 (likely to require consideration), HADS 11-21 (presence of anxiety/ depression relevant symptoms).
measure: Evaluation of lean mass index among subjects
time frame: Up to 9 months
description: The percentage of lean mass index will be evaluated and compared between COPD and non-COPD subjects by using bioimpedance. Body composition will be measured based on the electrical properties of biological tissues.
measure: Evaluation of exercise tolerance among subjects
time frame: Up to 9 months
description: Exercise tolerance between COPD and non-COPD subjects will be evaluated with the help of 6 minute walk test. The distance in meters and the reason for the stop will be measured, along with the initial and final heart rate and initial and final saturation of oxyhemoglobin (SatO2).
measure: To evaluate daily physical activity of subjects
time frame: Up to 9 months
description: The daily physical activity of COPD and non-COPD subjects will be compared using the Yale Physical Activity Survey (YPAS) questionnaire. YPAS will be calculated as the sum of the 5 sub-indices: index of vigorous activity, easy stroll index, moving index, standing index and sitting index. This index will range from 0 to 137 points. The subjects will be categorized into two groups namely YPAS less than 51 (sedentary subjects) and YPAS more than or equal to 51 (not sedentary subjects).
measure: Recording of age
time frame: Up to 9 months
description: Age will be recorded for descriptive analysis of the sociodemographic characteristics of the subjects participating in this study.
measure: Number of subjects with different sociodemographic characteristics
time frame: Up to 9 months
description: No. of subjects with different education level, gender, marital and smoking status will be recorded for descriptive analysis of the sociodemographic characteristics of the subjects participating in this study.
measure: Recording of body mass index (BMI)
time frame: Up to 9 months
description: BMI will be recorded for descriptive analysis of the sociodemographic characteristics of the subjects participating in this study.
measure: Number of instances of underdiagnosis and overdiagnosis of COPD in subjects
time frame: Up to 9 months
description: No. of instances of underdiagnosis will be described in the subsample of subjects who, despite declaring they had never received a previous diagnosis of COPD, reflect the presence of the disease from the study results. Also, the no. of instances of overdiagnosis will be described among those who claim having a prior diagnosis of COPD but who show this diagnosis to be unconfirmed after the study results. The correlation between the two variables will be analyzed using the Kappa index.
measure: Number of subjects with abnormal multidimensional assessment of COPD
time frame: Up to 9 months
description: No. of subjects with abnormal BMI, airflow Obstruction, Dyspnea and Exercise capacity (BODE) index ranging from 0-10 points and BMI, degree of dyspnea, pulmonary function and severe exacerbation (BODEX) index ranging from 0- 9 points will be recorded during multidimensional assessment of COPD.
measure: Number of subjects with abnormal density of lung attenuation and thickness of airway caliber
time frame: Up to 9 months
description: No. of subjects with attenuation of the lung parenchyma and thickness of the wall of the airway will be determined with the help of computed tomography (CT). No. of subjects with other abnormal parameters including the percentage of emphysema, extension areas, thickness of the airway, volume of the chest muscles, diameter of aorta vs. pulmonary artery, air trapping or coronary calcifications, bronchiectasis and fibrosis will also be assessed.
measure: Number of subjects with dyspnea and other respiratory symptoms, health-related quality of life, exercise tolerance, physical activity and systemic inflammation among COPD and non-COPD subjects
time frame: Up to 9 months
description: No. of subjects with intensity of dyspnea and other respiratory symptoms, health-related quality of life, exercise tolerance, physical activity and systemic inflammation will be assessed and compared between the COPD and non-COPD subjects depending on the amount of diffusion lung capacity.
arm group label: COPD
description: 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.
arm group label: Non-COPD
description: Subjects with FEV1/FVC score greater than or equal to 0.70 post-bronchodilator test will be allocated to non-COPD group.
intervention type: Procedure
intervention name: Medical tests
description: 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.
arm group label: COPD
arm group label: Non-COPD
intervention type: Other
intervention name: Questionnaire
description: 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.
arm group label: COPD
arm group label: Non-COPD
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
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country: Spain
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: No