<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/NCT03813810</url>
  </required_header>
  <id_info>
    <org_study_id>Air_pollution_cohort</org_study_id>
    <nct_id>NCT03813810</nct_id>
  </id_info>
  <brief_title>Impact of Air Pollution on Chronic Respiratory Diseases</brief_title>
  <official_title>The Impact of Air Pollution on Chronic Respiratory Diseases: a Prospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Seoul National University Bundang Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>SMG-SNU Boramae Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Medical Center, Seoul</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>KangWon National University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul National University Hospital</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>
      The aim of this study is to evaluate the impact of air pollution on the occurrence and&#xD;
      clinical course of chronic respiratory diseases, and discover new biomarkers from various&#xD;
      devices such as CT images that can indicate the process and amount of lung damage caused by&#xD;
      air pollution.&#xD;
&#xD;
      Accordingly, the investigators have designed an prospective cohort with enrollment of normal&#xD;
      people and patients with chronic respiratory diseases of three different categories (chronic&#xD;
      obstructive pulmonary disease, asthma, idiopathic pulmonary fibrosis). Participants will be&#xD;
      followed up for a period of one year, with evaluation of the clinical course of the&#xD;
      respiratory disease and exposure to air pollution.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Normal people (n=90) and patients with chronic respiratory diseases (chronic obstructive&#xD;
      pulmonary disease, asthma, idiopathic pulmonary fibrosis, n=90 for each disease) will be&#xD;
      enrolled at 5 different institutions in South Korea and followed up for one year.&#xD;
      Inspiratory-expiratory CTs and tests including physical examination and blood/urine tests&#xD;
      would be performed at the time of enrollment and the time at completion of the follow up&#xD;
      period for each participant. Participants would be checked for the residency and working&#xD;
      places, as well as checked for the amount of air pollution exposure using a wearable&#xD;
      measurement device for 5 days during the study period ( time at enrollment / 3 months / 6&#xD;
      months / 9 months / time at completion). The device would cause no effect on usual daily life&#xD;
      or the medical status of the participant. The clinical course such as occurrence of disease,&#xD;
      acute exacerbation, decline of lung function, imaging status, mortality would be evaluated as&#xD;
      well as the exposure of air pollution for each individual.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 25, 2019</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of mortality</measure>
    <time_frame>an average of 1 year</time_frame>
    <description>Events of mortality through study completion</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of acute exacerbations</measure>
    <time_frame>an average of 1 year</time_frame>
    <description>Events of acute exacerbations through study completion</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of disease extent in CT imaging</measure>
    <time_frame>an average of 1 year</time_frame>
    <description>Emphysema index (0-100, higher values representing worse outcome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in lung function</measure>
    <time_frame>an average of 1 year</time_frame>
    <description>FEV1 (forced expiratory volume at one second, 10-150 %, lower values representing worse outcome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in symptom scor</measure>
    <time_frame>an average of 1 year</time_frame>
    <description>St. George's Respiratory Questionnaire score (0-100, higher values representing worse outcome)</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">360</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <condition>Asthma</condition>
  <condition>Idiopathic Pulmonary Fibrosis</condition>
  <arm_group>
    <arm_group_label>Normal</arm_group_label>
    <description>People without any chronic pulmonary diseases.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chronic obstructive pulmonary disease</arm_group_label>
    <description>Patients with chronic obstructive pulmonary disease.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Asthma</arm_group_label>
    <description>Patients with asthma</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Idiopathic pulmonary fibrosis</arm_group_label>
    <description>Patients with idiopathic pulmonary fibrosis</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non</intervention_name>
    <description>There would be no interventions. Only measurements will be performed.</description>
    <arm_group_label>Asthma</arm_group_label>
    <arm_group_label>Chronic obstructive pulmonary disease</arm_group_label>
    <arm_group_label>Idiopathic pulmonary fibrosis</arm_group_label>
    <arm_group_label>Normal</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood, urine, induced sputum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Normal adults and adult patients with chronic respiratory disease (chronic obstructive&#xD;
        pulmonary disease, asthma, idiopathic pulmonary fibrosis)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Normal: People with no lung lesions in chest X-ray and St. George's Respiratory&#xD;
             Questionnaire score &lt;25, and post bronchodilator FEV1/FVC (forced expiratory volume at&#xD;
             one second/forced vital capacity) &gt;= 0.7 and FEV1 &gt;= 80% and FVC &gt;= 80%.&#xD;
&#xD;
          -  Chronic obstructive pulmonary disease: Patients with over 10 pack-years of smoking&#xD;
             history and post bronchodilator FEV1/FVC &lt;0.7 and FEV1 &lt; 80%, and no other reason for&#xD;
             decline of lung function.&#xD;
&#xD;
          -  Asthma: Patients with FEV1/FVC &lt; 0.85 and increase in over 12% and 200mL of FEV1 by&#xD;
             bronchodilator inhalation. Patients with P20 &lt; 16mg/dL by bronchial provocation test.&#xD;
&#xD;
          -  Idiopathic pulmonary fibrosis: Shows usual interstitial pneumonia according to chest&#xD;
             CT and has no other reasons such as systematic diseases or medication history.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who refused for enrollment in the study&#xD;
&#xD;
          -  Subjects who experienced an acute exacerbation within 1 month.&#xD;
&#xD;
          -  Subjects under age of 19.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 23, 2018</study_first_submitted>
  <study_first_submitted_qc>January 21, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>January 21, 2019</last_update_submitted>
  <last_update_submitted_qc>January 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    <mesh_term>Pulmonary Fibrosis</mesh_term>
    <mesh_term>Idiopathic Pulmonary Fibrosis</mesh_term>
    <mesh_term>Respiratory Tract Diseases</mesh_term>
    <mesh_term>Respiration Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03813810
org study id: Air_pollution_cohort
nct id: NCT03813810
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate the impact of air pollution on the occurrence and
      clinical course of chronic respiratory diseases, and discover new biomarkers from various
      devices such as CT images that can indicate the process and amount of lung damage caused by
      air pollution.

      Accordingly, the investigators have designed an prospective cohort with enrollment of normal
      people and patients with chronic respiratory diseases of three different categories (chronic
      obstructive pulmonary disease, asthma, idiopathic pulmonary fibrosis). Participants will be
      followed up for a period of one year, with evaluation of the clinical course of the
      respiratory disease and exposure to air pollution.
Normal people (n=90) and patients with chronic respiratory diseases (chronic obstructive
      pulmonary disease, asthma, idiopathic pulmonary fibrosis, n=90 for each disease) will be
      enrolled at 5 different institutions in South Korea and followed up for one year.
      Inspiratory-expiratory CTs and tests including physical examination and blood/urine tests
      would be performed at the time of enrollment and the time at completion of the follow up
      period for each participant. Participants would be checked for the residency and working
      places, as well as checked for the amount of air pollution exposure using a wearable
      measurement device for 5 days during the study period ( time at enrollment / 3 months / 6
      months / 9 months / time at completion). The device would cause no effect on usual daily life
      or the medical status of the participant. The clinical course such as occurrence of disease,
      acute exacerbation, decline of lung function, imaging status, mortality would be evaluated as
      well as the exposure of air pollution for each individual.
observational model: Cohort
time perspective: Prospective
measure: Rate of mortality
time frame: an average of 1 year
description: Events of mortality through study completion
measure: Rate of acute exacerbations
time frame: an average of 1 year
description: Events of acute exacerbations through study completion
measure: Change of disease extent in CT imaging
time frame: an average of 1 year
description: Emphysema index (0-100, higher values representing worse outcome)
measure: Change in lung function
time frame: an average of 1 year
description: FEV1 (forced expiratory volume at one second, 10-150 %, lower values representing worse outcome)
measure: Change in symptom scor
time frame: an average of 1 year
description: St. George's Respiratory Questionnaire score (0-100, higher values representing worse outcome)
arm group label: Normal
description: People without any chronic pulmonary diseases.
arm group label: Chronic obstructive pulmonary disease
description: Patients with chronic obstructive pulmonary disease.
arm group label: Asthma
description: Patients with asthma
arm group label: Idiopathic pulmonary fibrosis
description: Patients with idiopathic pulmonary fibrosis
intervention type: Other
intervention name: Non
description: There would be no interventions. Only measurements will be performed.
arm group label: Asthma
arm group label: Chronic obstructive pulmonary disease
arm group label: Idiopathic pulmonary fibrosis
arm group label: Normal
blood, urine, induced sputum
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Pulmonary Fibrosis
mesh term: Idiopathic Pulmonary Fibrosis
mesh term: Respiratory Tract Diseases
mesh term: Respiration Disorders
sharing ipd: Undecided