<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/NCT03241420</url>
  </required_header>
  <id_info>
    <org_study_id>HS-2985</org_study_id>
    <nct_id>NCT03241420</nct_id>
  </id_info>
  <brief_title>Utility of Lung Clearance Index Score as a Noninvasive Marker of Small Airways Disease</brief_title>
  <official_title>Utility of Lung Clearance Index Score as a Noninvasive Marker of Small Airways 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>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>
      To determine the utility and sensitivity of the lung clearance index (LCI) technique as a&#xD;
      marker of small airways disease in adults with chronic lung conditions compared to healthy&#xD;
      adults, adjusting for age, sex and smoking status.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Target Population and Enrollment. The study will recruit and consent 300 patients from our&#xD;
      Occupational Medicine and Interstitial Lung/Rheumatology Clinics at National Jewish Health&#xD;
      who have been referred for evaluation of chronic lung conditions. The healthy control group&#xD;
      will comprise 300 volunteers who are at least 18 years of age, have no history of&#xD;
      pre-existing lung disease, and report no respiratory illness in the four weeks preceding&#xD;
      enrollment. Inclusion criteria for the group with chronic lung disease will include physician&#xD;
      diagnosis of a chronic lung condition (e.g. bronchiolitis, pulmonary fibrosis, asthma, coal&#xD;
      mine dust lung disease, asbestosis), and age ≥18 years. Exclusion criteria will include&#xD;
      recent myocardial infarction, stroke, eye surgery, chest/abdominal surgery (within past&#xD;
      month), known thoracic, aortic, or cerebral aneurysm, or uncontrolled hypertension. Study&#xD;
      participation will consist of one visit that will last between 90-120 minutes. The chronic&#xD;
      lung disease group will fill out the informed consent and complete both LCI testing and&#xD;
      spirometry. The healthy control group will complete informed consent, a brief questionnaire,&#xD;
      LCI testing, and spirometry.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 24, 2017</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Lung Clearance Index (LCI) technique can be used as a marker of small airways disease in adults with chronic lung conditions</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Average of three acceptable trials.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Chronic Lung Disease</condition>
  <arm_group>
    <arm_group_label>Chronic Lung conditions</arm_group_label>
    <description>Study participation will consist of one visit: Informed consent, complete both Lung Clearance Index (LCI) testing and spirometry.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy control group</arm_group_label>
    <description>Study participation will consist of one visit: Informed consent, brief questionnaire, LCI testing and spirometry.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>lung clearance index (LCI)</intervention_name>
    <description>Determine the utility and sensitivity of the lung clearance index (LCI) technique as a marker of lung injury/small airways disease in adults with chronic lung conditions compared to health adults, adjusting for age, sex, and smoking status.</description>
    <arm_group_label>Chronic Lung conditions</arm_group_label>
    <arm_group_label>Healthy 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;
          -  physician diagnosis of a chronic lung condition (e.g. bronchiolitis, pulmonary&#xD;
             fibrosis, asthma, coal mine dust lung disease, asbestosis), and age ≥18 years.&#xD;
&#xD;
        The healthy control group will comprise 300 volunteers who are at least 18 years of age,&#xD;
        have no history of pre-existing lung disease, and report no respiratory illness in the four&#xD;
        weeks preceding enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria will include recent myocardial infarction, stroke, eye surgery,&#xD;
             chest/abdominal surgery (within past month), known thoracic, aortic, or cerebral&#xD;
             aneurysm, or uncontrolled hypertension.&#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>Zell-Baran LM, Krefft SD, Moore CM, Wolff J, Meehan R, Rose CS. Multiple breath washout: A noninvasive tool for identifying lung disease in symptomatic military deployers. Respir Med. 2021 Jan;176:106281. doi: 10.1016/j.rmed.2020.106281. Epub 2020 Dec 5.</citation>
    <PMID>33340829</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>May 2022</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>May 3, 2022</last_update_submitted>
  <last_update_submitted_qc>May 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 5, 2022</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>PI</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</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/NCT03241420
org study id: HS-2985
nct id: NCT03241420
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To determine the utility and sensitivity of the lung clearance index (LCI) technique as a
      marker of small airways disease in adults with chronic lung conditions compared to healthy
      adults, adjusting for age, sex and smoking status.
Target Population and Enrollment. The study will recruit and consent 300 patients from our
      Occupational Medicine and Interstitial Lung/Rheumatology Clinics at National Jewish Health
      who have been referred for evaluation of chronic lung conditions. The healthy control group
      will comprise 300 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. Inclusion criteria for the group with chronic lung disease will include physician
      diagnosis of a chronic lung condition (e.g. bronchiolitis, pulmonary fibrosis, asthma, coal
      mine dust lung disease, asbestosis), and age ≥18 years. Exclusion criteria will include
      recent myocardial infarction, stroke, eye surgery, chest/abdominal surgery (within past
      month), known thoracic, aortic, or cerebral aneurysm, or uncontrolled hypertension. Study
      participation will consist of one visit that will last between 90-120 minutes. The chronic
      lung disease group will fill out the informed consent and complete both LCI testing and
      spirometry. The healthy control group will complete informed consent, a brief questionnaire,
      LCI testing, and spirometry.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Lung Clearance Index (LCI) technique can be used as a marker of small airways disease in adults with chronic lung conditions
time frame: Up to 12 months
description: Average of three acceptable trials.
arm group label: Chronic Lung conditions
description: Study participation will consist of one visit: Informed consent, complete both Lung Clearance Index (LCI) testing and spirometry.
arm group label: Healthy control group
description: Study participation will consist of one visit: Informed consent, brief questionnaire, LCI testing and spirometry.
intervention type: Device
intervention name: lung clearance index (LCI)
description: Determine the utility and sensitivity of the lung clearance index (LCI) technique as a marker of lung injury/small airways disease in adults with chronic lung conditions compared to health adults, adjusting for age, sex, and smoking status.
arm group label: Chronic Lung conditions
arm group label: Healthy 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: Zell-Baran LM, Krefft SD, Moore CM, Wolff J, Meehan R, Rose CS. Multiple breath washout: A noninvasive tool for identifying lung disease in symptomatic military deployers. Respir Med. 2021 Jan;176:106281. doi: 10.1016/j.rmed.2020.106281. Epub 2020 Dec 5.
PMID: 33340829
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: PI
mesh term: Lung Diseases