<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/NCT03012958</url>
  </required_header>
  <id_info>
    <org_study_id>HS-2851</org_study_id>
    <nct_id>NCT03012958</nct_id>
  </id_info>
  <brief_title>Utility of Lung Clearance Index Score as a Noninvasive Marker of Deployment Lung Disease</brief_title>
  <acronym>LCI</acronym>
  <official_title>Utility of Lung Clearance Index Score as a Noninvasive Marker of Deployment Lung Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Jewish Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Jewish Health</source>
  <oversight_info>
    <has_dmc>Yes</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 purpose of this study is to learn more about new noninvasive ways of detecting lung&#xD;
      disease in US Military personnel and people who worked as contractors during military&#xD;
      operations in Iraq and Afghanistan. This study is looking at conducting a type of breathing&#xD;
      test called the lung clearance index (LCI) test which is being investigated as a potential&#xD;
      noninvasive way to detect the type of lung disease that may be seen in symptomatic deployers&#xD;
      retuning from Iraq and Afghanistan.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The healthy control group will comprise volunteers who are at least 18 years of age, have no&#xD;
      history of pre-existing lung disease, and report no respiratory illness in the four weeks&#xD;
      preceding enrollment.&#xD;
&#xD;
      The symptomatic deployers who have undergone lung biopsy and meet the case definition for&#xD;
      deployment-related lung disease. A case of deployment-related lung disease is defined as the&#xD;
      presence of unexplained chest symptoms in a deployer who, on a surgical lung biopsy, is found&#xD;
      to have bronchiolitis or granulomatous pneumonitis without other known cause.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">May 2018</completion_date>
  <primary_completion_date type="Actual">May 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>LCI parameters in symptomatic deployers compared to normal adults to determine whether LCI is an early marker of lung injury.</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Average of three acceptable trials</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between LCI score and the clinical characteristics of the population of deployers.</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Comparison with pulmonary function testing and other clinical measures</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">73</enrollment>
  <condition>Bronchiolitis</condition>
  <condition>Pneumonitis</condition>
  <condition>Dyspnea</condition>
  <arm_group>
    <arm_group_label>Health control group</arm_group_label>
    <description>Who are 18 years or older, have no history of pre-existing lung disease, and report no respiratory illness in the four weeks preceding enrollment.&#xD;
This study consist of one visit: If the potential subject meets the Inclusion and exclusion then they will have the LCI testing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Deployment-related lung disease</arm_group_label>
    <description>Defined as the presence of unexplained chest symptoms in a deployer who, on surgical lung biopsy is found to have bronchiolitis or granulomatous pneumonitis without other known causes.&#xD;
This study consist of one visit: If the potential subject meets the Inclusion and exclusion then they will have the LCI testing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Lung clearance index (LCI)</intervention_name>
    <description>LCI is determined by the number of lung volume turnovers necessary to clear the lungs of an inert tracer gas such as nitrogen that is inhaled at the beginning of the test. The LCI is calculated by determining the cumulative expired volume (CEV) and then dividing the CEV by the functional residual capacity. Values of less than7.0 indicate normal values while an LCI greater than 7.0 is associated with heterogeneity in ventilation and distal airway abnormalities. The ability to detect peripheral airway disease may make LCI a better modality for detecting distal airways abnormalities seen on lung histopathology but often missed on traditional pulmonary function testing.</description>
    <arm_group_label>Deployment-related lung disease</arm_group_label>
    <arm_group_label>Health control group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Symptomatic military deployers with deployment-related lung disease seen at National Jewish&#xD;
        Health and healthy controls subjects.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        For the deployer group:&#xD;
&#xD;
          -  presence of respiratory symptoms (cough, chest tightness, wheezing, shortness of&#xD;
             breath or decreased exercise tolerance) following deployment&#xD;
&#xD;
          -  history of deployment for Operation Iraqi Freedom, Operation Enduring Freedom or&#xD;
             Operation New Dawn for greater than or equal to 6 weeks as either military personnel&#xD;
             or a civilian contractor&#xD;
&#xD;
          -  prior VATS biopsy-proven histologic abnormalities of small airways disease.&#xD;
&#xD;
        For the control group:&#xD;
&#xD;
          -  no history of pre-existing lung disease&#xD;
&#xD;
          -  no respiratory illness in the four weeks preceding enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        For the deployer group:&#xD;
&#xD;
          -  If on clinical evaluation they were found to have asthma, vocal cord dysfunction or&#xD;
             other explanations for their respiratory symptoms and did not need to undergo surgical&#xD;
             lung biopsy for diagnosis.&#xD;
&#xD;
          -  unable to provide informed consent&#xD;
&#xD;
          -  pregnant subjects&#xD;
&#xD;
        For the control group:&#xD;
&#xD;
          -  pre-existing lung disease&#xD;
&#xD;
          -  unable to provide informed consent&#xD;
&#xD;
          -  pregnant subjects&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>National Jewish Health</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Krefft SD, Strand M, Smith J, Stroup C, Meehan R, Rose C. Utility of Lung Clearance Index Testing as a Noninvasive Marker of Deployment-related Lung Disease. J Occup Environ Med. 2017 Aug;59(8):707-711. doi: 10.1097/JOM.0000000000001058.</citation>
    <PMID>28665837</PMID>
  </reference>
  <reference>
    <citation>Zell-Baran LM, Krefft SD, Moore CM, Wolff J, Meehan R, Rose CS. Multiple breath washout test data for healthy controls. Data Brief. 2020 Dec 10;34:106641. doi: 10.1016/j.dib.2020.106641. eCollection 2021 Feb.</citation>
    <PMID>33365370</PMID>
  </reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>January 6, 2021</last_update_submitted>
  <last_update_submitted_qc>January 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Jewish Health</investigator_affiliation>
    <investigator_full_name>Cecile Rose Professor of Medicine</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchiolitis</mesh_term>
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Dyspnea</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/NCT03012958
org study id: HS-2851
nct id: NCT03012958
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to learn more about new noninvasive ways of detecting lung
      disease in US Military personnel and people who worked as contractors during military
      operations in Iraq and Afghanistan. This study is looking at conducting a type of breathing
      test called the lung clearance index (LCI) test which is being investigated as a potential
      noninvasive way to detect the type of lung disease that may be seen in symptomatic deployers
      retuning from Iraq and Afghanistan.
The healthy control group will comprise volunteers who are at least 18 years of age, have no
      history of pre-existing lung disease, and report no respiratory illness in the four weeks
      preceding enrollment.

      The symptomatic deployers who have undergone lung biopsy and meet the case definition for
      deployment-related lung disease. A case of deployment-related lung disease is defined as the
      presence of unexplained chest symptoms in a deployer who, on a surgical lung biopsy, is found
      to have bronchiolitis or granulomatous pneumonitis without other known cause.
observational model: Case-Control
time perspective: Cross-Sectional
measure: LCI parameters in symptomatic deployers compared to normal adults to determine whether LCI is an early marker of lung injury.
time frame: Up to 24 months
description: Average of three acceptable trials
measure: Correlation between LCI score and the clinical characteristics of the population of deployers.
time frame: Up to 24 months
description: Comparison with pulmonary function testing and other clinical measures
arm group label: Health control group
description: Who are 18 years or older, have no history of pre-existing lung disease, and report no respiratory illness in the four weeks preceding enrollment.
This study consist of one visit: If the potential subject meets the Inclusion and exclusion then they will have the LCI testing.
arm group label: Deployment-related lung disease
description: Defined as the presence of unexplained chest symptoms in a deployer who, on surgical lung biopsy is found to have bronchiolitis or granulomatous pneumonitis without other known causes.
This study consist of one visit: If the potential subject meets the Inclusion and exclusion then they will have the LCI testing.
intervention type: Other
intervention name: Lung clearance index (LCI)
description: LCI is determined by the number of lung volume turnovers necessary to clear the lungs of an inert tracer gas such as nitrogen that is inhaled at the beginning of the test. The LCI is calculated by determining the cumulative expired volume (CEV) and then dividing the CEV by the functional residual capacity. Values of less than7.0 indicate normal values while an LCI greater than 7.0 is associated with heterogeneity in ventilation and distal airway abnormalities. The ability to detect peripheral airway disease may make LCI a better modality for detecting distal airways abnormalities seen on lung histopathology but often missed on traditional pulmonary function testing.
arm group label: Deployment-related lung disease
arm group label: Health control group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
citation: Krefft SD, Strand M, Smith J, Stroup C, Meehan R, Rose C. Utility of Lung Clearance Index Testing as a Noninvasive Marker of Deployment-related Lung Disease. J Occup Environ Med. 2017 Aug;59(8):707-711. doi: 10.1097/JOM.0000000000001058.
PMID: 28665837
citation: Zell-Baran LM, Krefft SD, Moore CM, Wolff J, Meehan R, Rose CS. Multiple breath washout test data for healthy controls. Data Brief. 2020 Dec 10;34:106641. doi: 10.1016/j.dib.2020.106641. eCollection 2021 Feb.
PMID: 33365370
responsible party type: Principal Investigator
investigator affiliation: National Jewish Health
investigator full name: Cecile Rose Professor of Medicine
investigator title: Principal Investigator
mesh term: Bronchiolitis
mesh term: Pneumonia
mesh term: Lung Diseases
mesh term: Dyspnea
sharing ipd: Undecided