<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/NCT03823443</url>
  </required_header>
  <id_info>
    <org_study_id>AAAR3691</org_study_id>
    <nct_id>NCT03823443</nct_id>
  </id_info>
  <brief_title>COPD Exacerbation Blood and Urine Biomarkers Study</brief_title>
  <official_title>COPD Exacerbation Blood and Urine Biomarkers Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alpha-1 Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Columbia University</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>
      This will be a prospective study examining serum levels of MMP-13 and alpha-1 antitrypsin as&#xD;
      well as other biomarkers as well as urine biomarkers of smoking status and collagen&#xD;
      degradation in the COPD patient population. Serum and urine biomarkers at baseline and after&#xD;
      COPD exacerbations will be assessed against change in lung function as measured by pulmonary&#xD;
      function testing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic obstructive pulmonary disease (COPD), a term describing emphysema and chronic&#xD;
      bronchitis, is the third leading cause of death in the United States, with approximately 24&#xD;
      million US adults estimated to have the disease and over 130,000 US adults dying each year&#xD;
      due to COPD. Acute exacerbations of chronic obstructive pulmonary disease (AECOPD), primarily&#xD;
      the result of viral respiratory infections, result in accelerated decline in lung function&#xD;
      and increased mortality. Recent work in our laboratory demonstrates that matrix&#xD;
      metalloproteinase-13 (MMP-13), which has both collagenolytic and elastolytic activity, is&#xD;
      increased in the bronchoalveolar lavage fluid of patients with COPD. It is well accepted that&#xD;
      viral infections have significant consequences in smokers, particularly in patients with AATD&#xD;
      related COPD.&#xD;
&#xD;
      COPD exacerbations clinically manifest with increased dyspnea, cough and sputum production,&#xD;
      and from a societal cost standpoint are associated with significant increases in health care&#xD;
      utilization. Recent data suggest that viral infections such as RSV increase MMP-13 secretion&#xD;
      and expression within lung tissues. Therefore, the studies presented here seek to understand&#xD;
      the effect of MMP-13 on COPD progression and the effect of disease exacerbations on MMP-13&#xD;
      and alpha-1 antitrypsin serum levels and later lung function decline. The investigators&#xD;
      hypothesize that patients with COPD, in particular patients who fall into the &quot;frequent&#xD;
      exacerbator&quot; phenotype (two or more exacerbations within the last year), will have increased&#xD;
      levels of MMP-13 as compared to the general non-COPD patient population and that in the&#xD;
      setting of a COPD exacerbation, levels will be increased. The investigators will assess how&#xD;
      exacerbation MMP-13 levels predict later lung function decline.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 7, 2018</start_date>
  <completion_date type="Anticipated">August 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2024</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>MMP13 to Alpha-1 antitrypsin ratios</measure>
    <time_frame>1 year</time_frame>
    <description>Serum levels</description>
  </primary_outcome>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <condition>Acute Exacerbation Copd</condition>
  <condition>Alpha-1 Anti-trypsin Deficiency</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood, urine and nasal swab.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The patient population for this study will have a known diagnosis of COPD, confirmed by&#xD;
        pulmonary function testing.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with COPD (FEV1 &lt;80% AND FEV1/FVC &lt; 70%)&#xD;
&#xD;
          -  Ages 35-80yrs&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of Asthma&#xD;
&#xD;
          -  Bronchiectasis&#xD;
&#xD;
          -  Carcinoma of the bronchus&#xD;
&#xD;
          -  Recent COPD exacerbation or pulmonary infection (less than 1 month)&#xD;
&#xD;
          -  Other significant respiratory disease&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Monica Goldklang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Monica Goldklang, MD</last_name>
    <phone>212-305-3745</phone>
    <email>mpg2124@cumc.columbia.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Laura Fonseca</last_name>
    <phone>212-305-3745</phone>
    <email>lf2560@cumc.columbia.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Monica Goldklang, MD</last_name>
      <phone>212-305-3745</phone>
      <email>mpg2124@cumc.columbia.edu</email>
    </contact>
    <contact_backup>
      <last_name>Laura Fonseca</last_name>
      <phone>212-305-3745</phone>
      <email>lf2560@cumc.columbia.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Monica Goldklang, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>October 11, 2022</last_update_submitted>
  <last_update_submitted_qc>October 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>Monica Goldklang</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine (in Anesthesiology)</investigator_title>
  </responsible_party>
  <keyword>exacerbation</keyword>
  <keyword>cough</keyword>
  <keyword>sputum</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alpha 1-Antitrypsin Deficiency</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</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/NCT03823443
org study id: AAAR3691
nct id: NCT03823443
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This will be a prospective study examining serum levels of MMP-13 and alpha-1 antitrypsin as
      well as other biomarkers as well as urine biomarkers of smoking status and collagen
      degradation in the COPD patient population. Serum and urine biomarkers at baseline and after
      COPD exacerbations will be assessed against change in lung function as measured by pulmonary
      function testing.
Chronic obstructive pulmonary disease (COPD), a term describing emphysema and chronic
      bronchitis, is the third leading cause of death in the United States, with approximately 24
      million US adults estimated to have the disease and over 130,000 US adults dying each year
      due to COPD. Acute exacerbations of chronic obstructive pulmonary disease (AECOPD), primarily
      the result of viral respiratory infections, result in accelerated decline in lung function
      and increased mortality. Recent work in our laboratory demonstrates that matrix
      metalloproteinase-13 (MMP-13), which has both collagenolytic and elastolytic activity, is
      increased in the bronchoalveolar lavage fluid of patients with COPD. It is well accepted that
      viral infections have significant consequences in smokers, particularly in patients with AATD
      related COPD.

      COPD exacerbations clinically manifest with increased dyspnea, cough and sputum production,
      and from a societal cost standpoint are associated with significant increases in health care
      utilization. Recent data suggest that viral infections such as RSV increase MMP-13 secretion
      and expression within lung tissues. Therefore, the studies presented here seek to understand
      the effect of MMP-13 on COPD progression and the effect of disease exacerbations on MMP-13
      and alpha-1 antitrypsin serum levels and later lung function decline. The investigators
      hypothesize that patients with COPD, in particular patients who fall into the "frequent
      exacerbator" phenotype (two or more exacerbations within the last year), will have increased
      levels of MMP-13 as compared to the general non-COPD patient population and that in the
      setting of a COPD exacerbation, levels will be increased. The investigators will assess how
      exacerbation MMP-13 levels predict later lung function decline.
observational model: Cohort
time perspective: Prospective
measure: MMP13 to Alpha-1 antitrypsin ratios
time frame: 1 year
description: Serum levels
Blood, urine and nasal swab.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 35 Years
maximum age: 80 Years
healthy volunteers: No
last name: Monica Goldklang, MD
role: Principal Investigator
affiliation: Columbia University
last name: Monica Goldklang, MD
phone: 212-305-3745
email: mpg2124@cumc.columbia.edu
last name: Laura Fonseca
phone: 212-305-3745
email: lf2560@cumc.columbia.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: Monica Goldklang
investigator title: Assistant Professor of Medicine (in Anesthesiology)
mesh term: Alpha 1-Antitrypsin Deficiency
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive