<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/NCT03018808</url>
  </required_header>
  <id_info>
    <org_study_id>207620</org_study_id>
    <nct_id>NCT03018808</nct_id>
  </id_info>
  <brief_title>Prevalence of Chronic Obstructive Pulmonary Disease (COPD) and Eosinophilia Among Primary Care Patients</brief_title>
  <official_title>A Cross-sectional Study to Characterize the Prevalence of COPD and Eosinophilia Among Primary Care Patients in Brazil</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </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>
      Early diagnosis and appropriate treatment for COPD subjects are both critical to minimize the&#xD;
      progression of COPD and improve outcomes. Also, evidence suggests that high eosinophil&#xD;
      (specific type of white blood cell that protects body against certain kinds of germs) level&#xD;
      is associated with increased risk of both moderate and severe exacerbations in COPD subjects.&#xD;
      To date, there is insufficient amount of data that describes the prevalence of COPD in&#xD;
      Brazilian primary care units. Thus, this multicenter, cross-sectional study conducted in five&#xD;
      centers located in five different Brazilian cities will provide estimation about the&#xD;
      prevalence of COPD in primary care and will also determine the levels of eosinophils in&#xD;
      subjects with confirmed COPD diagnosis. Approximately 2,500 eligible subjects are expected to&#xD;
      be enrolled in the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a cross sectional (prevalence study).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 3, 2019</start_date>
  <completion_date type="Actual">October 4, 2021</completion_date>
  <primary_completion_date type="Actual">October 4, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects with spirometry confirmed COPD diagnosis according to Fixed Ratio Criteria</measure>
    <time_frame>Day 1</time_frame>
    <description>Spirometry confirmed COPD diagnosis according to fixed ratio criteria will be defined as those with post-Bronchodilatador (BD) Forced Expiratory Volume in 1 second (FEV1)/ Forced Vital Capacity (FVC) &lt; 0.7 among the total of patients with valid spirometry. Spirometry tests will be performed at Baseline and 15 minutes after the administration of 400 microgram (mcg) Salbutamol.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with spirometry confirmed COPD diagnosis according to Lower Limit of Normal (LLN) Criteria</measure>
    <time_frame>Day 1</time_frame>
    <description>Spirometry confirmed COPD diagnosis according to Lower limit of normal (LNN) criteria will be defined as those with lower 5th percentile for predicted post-BD FEV1/FVC Spirometry tests will be performed at Baseline and 15 minutes after the administration of 400 mcg Salbutamol.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects who self-reported physician diagnosis of COPD</measure>
    <time_frame>Day 1</time_frame>
    <description>Number of subjects that self-report physician diagnosis of emphysema, chronic bronchitis, or COPD.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with under diagnosed COPD</measure>
    <time_frame>Day 1</time_frame>
    <description>Number of subjects who meet the spirometry confirmed criteria of COPD (post-BD FEV1/FVC&lt;0.7) but do not self-report medical diagnosis of emphysema, chronic bronchitis, or COPD.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with physician COPD diagnosis</measure>
    <time_frame>Day 1</time_frame>
    <description>Number of subjects who meet the spirometry confirmed criteria of COPD(post-BD FEV1/FVC&lt;0.7) and self-report medical diagnosis of emphysema, chronic bronchitis, or COPD.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with misdiagnosed COPD</measure>
    <time_frame>Day 1</time_frame>
    <description>Number of subjects who do not meet the spirometry confirmed criteria of COPD but self-report diagnosis of emphysema, chronic bronchitis, or COPD.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number OF COPD subjects classified by Global Initiative for Chronic Obstructive Lung Disease (GOLD) Severity Groups</measure>
    <time_frame>Day 1</time_frame>
    <description>COPD subjects will be classified using the following severity classification: GOLD 2007 (GOLD, 2007); GOLD 2013 (GOLD, 2013); GOLD 2017 (GOLD, 2017).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Charlson Comorbidity Index (CCI) score</measure>
    <time_frame>Day 1</time_frame>
    <description>All comorbidities included in the CCI will be investigated. The CCI contains 19 categories of comorbidity and predicts the ten-year mortality for a subject who may have a range of co-morbid conditions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Descriptive statistics for COPD Assessment Test (CAT) score</measure>
    <time_frame>Day 1</time_frame>
    <description>Mean, Median, Max-Min, Q1-Q3 for CAT score will be described.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with mild exacerbation</measure>
    <time_frame>Day 1</time_frame>
    <description>Mild exacerbation will be defined as the deterioration of breathing symptoms that affected usual daily activities self-reported by the subject.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects moderate exacerbation</measure>
    <time_frame>Day 1</time_frame>
    <description>Moderate exacerbation will be defined as the one for which subjects need to take antibiotic and/or systemic corticosteroid due to increase of cough, phlegm or breathlessness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with severe exacerbation</measure>
    <time_frame>Day 1</time_frame>
    <description>Proportion of patients that needed to be hospitalized due to increase of cough, phlegm or breathlessness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of treatment used in the last 14 days and an last year</measure>
    <time_frame>Day 1</time_frame>
    <description>Subjects will report the COPD medication used in the last 14 days and in the last year.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of access to treatment</measure>
    <time_frame>Day 1</time_frame>
    <description>Subject will report where the medication (s) were obtained from (Public Health System, commercial pharmacy, charity institution/church, Brazilian Popular Pharmacy Program, free sample, friends/family/neighbor or other) at the last time they need such medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with Asthma-COPD Overlap (ACO)</measure>
    <time_frame>Day 1</time_frame>
    <description>It will be considered two definitions for considering a patient with ACO: 1) Subjects with Spirometry confirmed COPD post- BD increase in FEV1 or FVC of 200 milliliter (mL) and 12 percent plus self-reported wheezing in the last 12 months reported on the medical interview among all subjects with spirometry confirmed COPD. 2) subjects having a spirometry confirmed COPD and self-reported asthma physician diagnosis among all subjects with spirometry confirmed COPD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Descriptive statistics for blood eosinophil's concentration</measure>
    <time_frame>Day 1</time_frame>
    <description>Geometric mean accompanied with 95% confidence intervals</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with blood eosinophil's &lt; 150, &gt;= 150; &lt;300 and &gt;= 300 Cells/Microliter</measure>
    <time_frame>Day 1</time_frame>
    <description>A 5 mL sample of venous blood will be collected from each subject in order to have the complete blood count with differential count.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects classified by Brazilian Society of Pulmonology and Physiology (SBPT) severity groups</measure>
    <time_frame>Day 1</time_frame>
    <description>COPD subjects will be classified using the SBPT 2017 classification system.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Descriptive statistics for FEV1</measure>
    <time_frame>Day 1</time_frame>
    <description>Descriptive statistics for FEV1 will be summarized.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean CCI score as a measure of clinical characteristics by ACO definitions</measure>
    <time_frame>Day 1</time_frame>
    <description>All comorbidities included in the CCI will be investigated. The CCI contains 19 categories of comorbidity and predicts the ten-year mortality for a subject who may have a range of co-morbid conditions. Each condition is assigned a score of 1, 2, 3, or 6, depending on the risk of dying associated with each one.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Descriptive statistics for CAT score as a measure of clinical characteristics by ACO definitions</measure>
    <time_frame>Day 1</time_frame>
    <description>Mean, Median, Max-Min, Q1-Q3 for CAT score will be described.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Descriptive statistics for FEV1 as a measure of clinical characteristics by ACO definitions</measure>
    <time_frame>Day 1</time_frame>
    <description>Descriptive statistics for FEV1 will be summarized.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with mild exacerbation by ACO definition</measure>
    <time_frame>Day 1</time_frame>
    <description>Mild Exacerbation will be defined as the deterioration of breathing symptoms that affected usual daily activities self-reported by the subject.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with moderate exacerbation by ACO definition</measure>
    <time_frame>Day 1</time_frame>
    <description>Moderate exacerbation will be defined as the one for which subjects need to take antibiotic and/or systemic corticosteroid due to increase of cough, phlegm or breathlessness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with severe exacerbation by ACO definition</measure>
    <time_frame>Day 1</time_frame>
    <description>Proportion of patients that needed to be hospitalized due to increase of cough, phlegm or breathlessness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean CCI score as a measure of clinical characteristics of eosinophil groups</measure>
    <time_frame>Day 1</time_frame>
    <description>All comorbidities included in the CCI will be investigated. The CCI contains 19 categories of comorbidity and predicts the ten-year mortality for a subject who may have a range of co-morbid conditions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Descriptive statistics for CAT score as a measure of clinical characteristics of eosinophil groups</measure>
    <time_frame>Day 1</time_frame>
    <description>Mean, Median, Max-Min, Q1-Q3 for CAT score will be described. Subjects identified with COPD will complete the CAT to measure the impact of COPD on a person's life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Descriptive statistics for FEV1 as a measure of clinical characteristics of eosinophil groups</measure>
    <time_frame>Day 1</time_frame>
    <description>Descriptive statistics for FEV1 will be summarized.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with mild exacerbation of eosinophil groups</measure>
    <time_frame>Day 1</time_frame>
    <description>Mild Exacerbation will be defined as the deterioration of breathing symptoms that affected usual daily activities self-reported by the subject.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with moderate exacerbation of eosinophil groups</measure>
    <time_frame>Day 1</time_frame>
    <description>Moderate exacerbation will be defined as the one for which subjects need to take antibiotic and/or systemic corticosteroid due to increase of cough, phlegm or breathlessness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with severe exacerbation of eosinophil groups</measure>
    <time_frame>Day 1</time_frame>
    <description>Proportion of patients that needed to be hospitalized due to increase of cough, phlegm or breathlessness.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">800</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <arm_group>
    <arm_group_label>Subjects met inclusion with at least one exclusion criteria</arm_group_label>
    <description>Subjects who meet all the inclusion criteria, but have at least one exclusion criteria or not agree to participate in the whole study will be invited to sign a special ICF in order to complete a minimal questionnaire.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subjects who satisfy all inclusion/exclusion criteria</arm_group_label>
    <description>Subjects who satisfy all inclusion/exclusion criteria and agree to sign the ICF, an interview will be conducted for information regarding medical history, sociodemographic and clinical information, including disease history, treatment history, smoking habits and use of biomass.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Spirometry confirmed COPD Subjects</arm_group_label>
    <description>The spirometry confirmed COPD patients will be requested to complete the COPD Assessment Test (CAT), self-administered questionnaire related to quality of life on COPD patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Minimal questionnaire</intervention_name>
    <description>The minimal questionnaire is a reduced version of the medical interview and it will include questions about sociodemographic information, previous diagnosis of COPD, co-morbidities and smoking habits.</description>
    <arm_group_label>Subjects met inclusion with at least one exclusion criteria</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Medical interview</intervention_name>
    <description>Medical interview includes medical history, sociodemographic and clinical information, including disease history, treatment history, smoking habits and use of biomass.</description>
    <arm_group_label>Spirometry confirmed COPD Subjects</arm_group_label>
    <arm_group_label>Subjects who satisfy all inclusion/exclusion criteria</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CAT</intervention_name>
    <description>The CAT is a questionnaire for COPD patients and is designed to measure the impact of COPD on a person's life over time.</description>
    <arm_group_label>Spirometry confirmed COPD Subjects</arm_group_label>
    <arm_group_label>Subjects met inclusion with at least one exclusion criteria</arm_group_label>
    <arm_group_label>Subjects who satisfy all inclusion/exclusion criteria</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood test</intervention_name>
    <description>Blood samples will be collected at indicated time points</description>
    <arm_group_label>Subjects met inclusion with at least one exclusion criteria</arm_group_label>
    <arm_group_label>Subjects who satisfy all inclusion/exclusion criteria</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>anthropometric measures</intervention_name>
    <description>Anthropologic measures will be performed.</description>
    <arm_group_label>Subjects met inclusion with at least one exclusion criteria</arm_group_label>
    <arm_group_label>Subjects who satisfy all inclusion/exclusion criteria</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Oximetry</intervention_name>
    <description>Digital pulse oximeter on the index finger after five minutes rest and before receiving bronchodilator for spirometry will be used to measure the pulse arterial oximetry. The average of three measurements at 10 second intervals will be recorded. The heart rate will be provided by the pulse oximeter.</description>
    <arm_group_label>Subjects met inclusion with at least one exclusion criteria</arm_group_label>
    <arm_group_label>Subjects who satisfy all inclusion/exclusion criteria</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects over 35 years, with at least one COPD risk factor, who visit the Basic Health Unit&#xD;
        (BHU) for a routine, spontaneous or scheduled medical visit for any cause&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult &gt;= 35 years old&#xD;
&#xD;
          -  At least one of the following risk factors for COPD:&#xD;
&#xD;
             • being a current smoker (who has smoked 100 cigarettes in his or her lifetime and who&#xD;
             currently smokes cigarettes) or past smoker (who has smoked at least 100 cigarettes in&#xD;
             his or her lifetime but who had quit smoking at the time of interview); Current or&#xD;
             past exposure to biomass smoke, such as wood or coal, for cooking or heating (exposure&#xD;
             &gt;=100 hours/year&#xD;
&#xD;
          -  Capable of giving signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Physical or mental disability to complete the study procedures&#xD;
&#xD;
          -  Heart above 120 beats per minute&#xD;
&#xD;
          -  Participants under treatment for tuberculosis&#xD;
&#xD;
          -  Participant in current clinical trial&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Patients with one of the following contraindications to spirometry: chest surgery in&#xD;
             the last month; abdominal surgery within the past three months; neuromuscular disease,&#xD;
             acute coronary syndrome; retinal detachment; hospitalization for any cardiac problem&#xD;
             in the prior 3 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 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>Londrina</city>
        <state>Paraná</state>
        <zip>86039-440</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>90610-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Araraquara</city>
        <state>São Paulo</state>
        <zip>14801-320</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Botucatu</city>
        <state>São Paulo</state>
        <zip>18618686</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>April 11, 2022</last_update_submitted>
  <last_update_submitted_qc>April 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Eosinophilia</keyword>
  <keyword>COPD prevalence</keyword>
  <keyword>Primary care subjects</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>
    <mesh_term>Eosinophilia</mesh_term>
  </condition_browse>
  <!-- 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/NCT03018808
org study id: 207620
nct id: NCT03018808
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Early diagnosis and appropriate treatment for COPD subjects are both critical to minimize the
      progression of COPD and improve outcomes. Also, evidence suggests that high eosinophil
      (specific type of white blood cell that protects body against certain kinds of germs) level
      is associated with increased risk of both moderate and severe exacerbations in COPD subjects.
      To date, there is insufficient amount of data that describes the prevalence of COPD in
      Brazilian primary care units. Thus, this multicenter, cross-sectional study conducted in five
      centers located in five different Brazilian cities will provide estimation about the
      prevalence of COPD in primary care and will also determine the levels of eosinophils in
      subjects with confirmed COPD diagnosis. Approximately 2,500 eligible subjects are expected to
      be enrolled in the study.
The study is a cross sectional (prevalence study).
observational model: Other
time perspective: Cross-Sectional
measure: Number of subjects with spirometry confirmed COPD diagnosis according to Fixed Ratio Criteria
time frame: Day 1
description: Spirometry confirmed COPD diagnosis according to fixed ratio criteria will be defined as those with post-Bronchodilatador (BD) Forced Expiratory Volume in 1 second (FEV1)/ Forced Vital Capacity (FVC) < 0.7 among the total of patients with valid spirometry. Spirometry tests will be performed at Baseline and 15 minutes after the administration of 400 microgram (mcg) Salbutamol.
measure: Number of subjects with spirometry confirmed COPD diagnosis according to Lower Limit of Normal (LLN) Criteria
time frame: Day 1
description: Spirometry confirmed COPD diagnosis according to Lower limit of normal (LNN) criteria will be defined as those with lower 5th percentile for predicted post-BD FEV1/FVC Spirometry tests will be performed at Baseline and 15 minutes after the administration of 400 mcg Salbutamol.
measure: Number of subjects who self-reported physician diagnosis of COPD
time frame: Day 1
description: Number of subjects that self-report physician diagnosis of emphysema, chronic bronchitis, or COPD.
measure: Number of subjects with under diagnosed COPD
time frame: Day 1
description: Number of subjects who meet the spirometry confirmed criteria of COPD (post-BD FEV1/FVC<0.7) but do not self-report medical diagnosis of emphysema, chronic bronchitis, or COPD.
measure: Number of subjects with physician COPD diagnosis
time frame: Day 1
description: Number of subjects who meet the spirometry confirmed criteria of COPD(post-BD FEV1/FVC<0.7) and self-report medical diagnosis of emphysema, chronic bronchitis, or COPD.
measure: Number of subjects with misdiagnosed COPD
time frame: Day 1
description: Number of subjects who do not meet the spirometry confirmed criteria of COPD but self-report diagnosis of emphysema, chronic bronchitis, or COPD.
measure: Number OF COPD subjects classified by Global Initiative for Chronic Obstructive Lung Disease (GOLD) Severity Groups
time frame: Day 1
description: COPD subjects will be classified using the following severity classification: GOLD 2007 (GOLD, 2007); GOLD 2013 (GOLD, 2013); GOLD 2017 (GOLD, 2017).
measure: Mean Charlson Comorbidity Index (CCI) score
time frame: Day 1
description: All comorbidities included in the CCI will be investigated. The CCI contains 19 categories of comorbidity and predicts the ten-year mortality for a subject who may have a range of co-morbid conditions.
measure: Descriptive statistics for COPD Assessment Test (CAT) score
time frame: Day 1
description: Mean, Median, Max-Min, Q1-Q3 for CAT score will be described.
measure: Number of subjects with mild exacerbation
time frame: Day 1
description: Mild exacerbation will be defined as the deterioration of breathing symptoms that affected usual daily activities self-reported by the subject.
measure: Number of subjects moderate exacerbation
time frame: Day 1
description: Moderate exacerbation will be defined as the one for which subjects need to take antibiotic and/or systemic corticosteroid due to increase of cough, phlegm or breathlessness.
measure: Number of subjects with severe exacerbation
time frame: Day 1
description: Proportion of patients that needed to be hospitalized due to increase of cough, phlegm or breathlessness
measure: Assessment of treatment used in the last 14 days and an last year
time frame: Day 1
description: Subjects will report the COPD medication used in the last 14 days and in the last year.
measure: Type of access to treatment
time frame: Day 1
description: Subject will report where the medication (s) were obtained from (Public Health System, commercial pharmacy, charity institution/church, Brazilian Popular Pharmacy Program, free sample, friends/family/neighbor or other) at the last time they need such medication.
measure: Number of subjects with Asthma-COPD Overlap (ACO)
time frame: Day 1
description: It will be considered two definitions for considering a patient with ACO: 1) Subjects with Spirometry confirmed COPD post- BD increase in FEV1 or FVC of 200 milliliter (mL) and 12 percent plus self-reported wheezing in the last 12 months reported on the medical interview among all subjects with spirometry confirmed COPD. 2) subjects having a spirometry confirmed COPD and self-reported asthma physician diagnosis among all subjects with spirometry confirmed COPD.
measure: Descriptive statistics for blood eosinophil's concentration
time frame: Day 1
description: Geometric mean accompanied with 95% confidence intervals
measure: Number of subjects with blood eosinophil's < 150, >= 150; <300 and >= 300 Cells/Microliter
time frame: Day 1
description: A 5 mL sample of venous blood will be collected from each subject in order to have the complete blood count with differential count.
measure: Number of subjects classified by Brazilian Society of Pulmonology and Physiology (SBPT) severity groups
time frame: Day 1
description: COPD subjects will be classified using the SBPT 2017 classification system.
measure: Descriptive statistics for FEV1
time frame: Day 1
description: Descriptive statistics for FEV1 will be summarized.
measure: Mean CCI score as a measure of clinical characteristics by ACO definitions
time frame: Day 1
description: All comorbidities included in the CCI will be investigated. The CCI contains 19 categories of comorbidity and predicts the ten-year mortality for a subject who may have a range of co-morbid conditions. Each condition is assigned a score of 1, 2, 3, or 6, depending on the risk of dying associated with each one.
measure: Descriptive statistics for CAT score as a measure of clinical characteristics by ACO definitions
time frame: Day 1
description: Mean, Median, Max-Min, Q1-Q3 for CAT score will be described.
measure: Descriptive statistics for FEV1 as a measure of clinical characteristics by ACO definitions
time frame: Day 1
description: Descriptive statistics for FEV1 will be summarized.
measure: Number of subjects with mild exacerbation by ACO definition
time frame: Day 1
description: Mild Exacerbation will be defined as the deterioration of breathing symptoms that affected usual daily activities self-reported by the subject.
measure: Number of subjects with moderate exacerbation by ACO definition
time frame: Day 1
description: Moderate exacerbation will be defined as the one for which subjects need to take antibiotic and/or systemic corticosteroid due to increase of cough, phlegm or breathlessness.
measure: Number of subjects with severe exacerbation by ACO definition
time frame: Day 1
description: Proportion of patients that needed to be hospitalized due to increase of cough, phlegm or breathlessness.
measure: Mean CCI score as a measure of clinical characteristics of eosinophil groups
time frame: Day 1
description: All comorbidities included in the CCI will be investigated. The CCI contains 19 categories of comorbidity and predicts the ten-year mortality for a subject who may have a range of co-morbid conditions.
measure: Descriptive statistics for CAT score as a measure of clinical characteristics of eosinophil groups
time frame: Day 1
description: Mean, Median, Max-Min, Q1-Q3 for CAT score will be described. Subjects identified with COPD will complete the CAT to measure the impact of COPD on a person's life.
measure: Descriptive statistics for FEV1 as a measure of clinical characteristics of eosinophil groups
time frame: Day 1
description: Descriptive statistics for FEV1 will be summarized.
measure: Number of subjects with mild exacerbation of eosinophil groups
time frame: Day 1
description: Mild Exacerbation will be defined as the deterioration of breathing symptoms that affected usual daily activities self-reported by the subject.
measure: Number of subjects with moderate exacerbation of eosinophil groups
time frame: Day 1
description: Moderate exacerbation will be defined as the one for which subjects need to take antibiotic and/or systemic corticosteroid due to increase of cough, phlegm or breathlessness.
measure: Number of subjects with severe exacerbation of eosinophil groups
time frame: Day 1
description: Proportion of patients that needed to be hospitalized due to increase of cough, phlegm or breathlessness.
arm group label: Subjects met inclusion with at least one exclusion criteria
description: Subjects who meet all the inclusion criteria, but have at least one exclusion criteria or not agree to participate in the whole study will be invited to sign a special ICF in order to complete a minimal questionnaire.
arm group label: Subjects who satisfy all inclusion/exclusion criteria
description: Subjects who satisfy all inclusion/exclusion criteria and agree to sign the ICF, an interview will be conducted for information regarding medical history, sociodemographic and clinical information, including disease history, treatment history, smoking habits and use of biomass.
arm group label: Spirometry confirmed COPD Subjects
description: The spirometry confirmed COPD patients will be requested to complete the COPD Assessment Test (CAT), self-administered questionnaire related to quality of life on COPD patients.
intervention type: Other
intervention name: Minimal questionnaire
description: The minimal questionnaire is a reduced version of the medical interview and it will include questions about sociodemographic information, previous diagnosis of COPD, co-morbidities and smoking habits.
arm group label: Subjects met inclusion with at least one exclusion criteria
intervention type: Other
intervention name: Medical interview
description: Medical interview includes medical history, sociodemographic and clinical information, including disease history, treatment history, smoking habits and use of biomass.
arm group label: Spirometry confirmed COPD Subjects
arm group label: Subjects who satisfy all inclusion/exclusion criteria
intervention type: Other
intervention name: CAT
description: The CAT is a questionnaire for COPD patients and is designed to measure the impact of COPD on a person's life over time.
arm group label: Spirometry confirmed COPD Subjects
arm group label: Subjects met inclusion with at least one exclusion criteria
arm group label: Subjects who satisfy all inclusion/exclusion criteria
intervention type: Procedure
intervention name: Blood test
description: Blood samples will be collected at indicated time points
arm group label: Subjects met inclusion with at least one exclusion criteria
arm group label: Subjects who satisfy all inclusion/exclusion criteria
intervention type: Other
intervention name: anthropometric measures
description: Anthropologic measures will be performed.
arm group label: Subjects met inclusion with at least one exclusion criteria
arm group label: Subjects who satisfy all inclusion/exclusion criteria
intervention type: Other
intervention name: Oximetry
description: Digital pulse oximeter on the index finger after five minutes rest and before receiving bronchodilator for spirometry will be used to measure the pulse arterial oximetry. The average of three measurements at 10 second intervals will be recorded. The heart rate will be provided by the pulse oximeter.
arm group label: Subjects met inclusion with at least one exclusion criteria
arm group label: Subjects who satisfy all inclusion/exclusion criteria
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 35 Years
maximum age: N/A
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
facility: 
facility: 
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Eosinophilia