xml: <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/NCT05989360</url>
    </required_header>
    <id_info>
      <org_study_id>273069</org_study_id>
      <nct_id>NCT05989360</nct_id>
    </id_info>
    <brief_title>The Utility of Lung Clearance Index in Ethnic Groups and in Disease</brief_title>
    <acronym>LUCI-ED</acronym>
    <official_title>The Utility of Lung Clearance Index in Ethnic Groups and in Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Birmingham Women's and Children's NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Birmingham Women's and Children's NHS Foundation Trust</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>
        Introduction:&#xD;
  &#xD;
        Non-CF, non-PCD bronchiectasis in children is a chronic, suppurative lung disease diagnosed&#xD;
        by high resolution computed tomography (HRCT) imaging of the lungs. Spirometry can be&#xD;
        abnormal in bronchiectasis but has been shown to be insensitive to early disease in other&#xD;
        related conditions such as cystic fibrosis. Lung clearance index (LCI) could have a role in&#xD;
        assessment of the disease.&#xD;
  &#xD;
        Lung clearance index is calculated from multiple breath washout tests. There are limited data&#xD;
        on the normative values expected using some devices, in a range of ages, and between ethnic&#xD;
        groups.&#xD;
  &#xD;
        The investigators aim to establish normative values in children aged between 6 years and 12&#xD;
        years, to investigate differences between ethnic groups, and to establish the relationship&#xD;
        between lung clearance index and other measures of disease in children with bronchiectasis.&#xD;
  &#xD;
        Methods:&#xD;
  &#xD;
        Healthy children will be recruited from a range of settings and reviewed to ensure no&#xD;
        previous lung disease. Children with bronchiectasis diagnosed on HRCT will be recruited from&#xD;
        the outpatient service of Birmingham Children's Hospital.&#xD;
  &#xD;
        All participants will perform lung function tests including LCI and spirometry. Basic&#xD;
        demographic data was collected.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Rationale / Hypothesis:&#xD;
  &#xD;
        Hypothesis 1&#xD;
  &#xD;
        Having established normative ranges helps support interpretation of lung function testing&#xD;
        which is key to their value as an investigation. With LCI, it is important to understand the&#xD;
        difference that may be expected between children&#xD;
  &#xD;
        of different ethnic backgrounds (as demonstrated with other, non-LCI measures of lung&#xD;
        function, where important differences between different ethnic groups has been found).&#xD;
  &#xD;
        LCI is calculated from an internally adjusted measure of an individual subject's lung volume,&#xD;
        therefore potentially negating inherent differences in ethnic variation.&#xD;
  &#xD;
        Therefore we hypothesize that there are no differences in LCI in healthy children from&#xD;
        differing ethnic backgrounds.&#xD;
  &#xD;
        Evidence supporting this hypothesis is not only of intellectual value, but it would also&#xD;
        allow clinicians to confidently interpret a range of LCI readings using globally acquired&#xD;
        normal values. Should the data not support the hypothesis, an important direction for future&#xD;
        research would be established.&#xD;
  &#xD;
        Hypothesis 2&#xD;
  &#xD;
        LCI has been demonstrated to detect small differences in lung function and correlates well&#xD;
        with CT imaging in some disease states. There is a paucity of data in its use in its lung&#xD;
        disease outside of CF. Current availability of easy to use, repeatable and reliable devices&#xD;
        allows LCI to be measured in the clinic setting (Downing et al. 2016).&#xD;
  &#xD;
        Understanding the relationship between CT changes and LCI in younger children with lung&#xD;
        disease, would allow a non-invasive investigation (LCI) to be used to guide care and monitor&#xD;
        treatment.&#xD;
  &#xD;
        In order to understand how LCI changes, we also intend to determine how LCI varies in&#xD;
        children with Non-CF, Non-PCD Bronchiectasis over a prolonged period of time.&#xD;
  &#xD;
        The investigators hypothesize that in younger children with Non-CF, Non-PCD Bronchiectasis&#xD;
        and evidence of milder disease on CT, LCI is a more sensitive disease marker than FEV1, and&#xD;
        varies over time.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 11, 2020</start_date>
    <completion_date type="Actual">September 1, 2022</completion_date>
    <primary_completion_date type="Actual">September 1, 2022</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Normative values in healthy children</measure>
      <time_frame>24 months</time_frame>
      <description>The normative range of measurements of lung clearance index will be determined</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">85</enrollment>
    <condition>Healthy Children</condition>
    <condition>Bronchiectasis Adult</condition>
    <condition>Lung Clearance Index</condition>
    <arm_group>
      <arm_group_label>observational</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Lung Clearance Index</intervention_name>
      <description>Normative values in healthy children from ethnic backgrounds</description>
      <arm_group_label>observational</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy children&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Those with underlying respiratory/systemic disease/ prematurity&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Prasad Nagakumar, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Birmingham Women's and Children's Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Birmingham Children's Hospital</name>
        <address>
          <city>Birmingham</city>
          <state>West Midlands</state>
          <zip>B4 6NH</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</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>Bronchiectasis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05989360
  org study id: 273069
  nct id: NCT05989360
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Introduction:
  
        Non-CF, non-PCD bronchiectasis in children is a chronic, suppurative lung disease diagnosed
        by high resolution computed tomography (HRCT) imaging of the lungs. Spirometry can be
        abnormal in bronchiectasis but has been shown to be insensitive to early disease in other
        related conditions such as cystic fibrosis. Lung clearance index (LCI) could have a role in
        assessment of the disease.
  
        Lung clearance index is calculated from multiple breath washout tests. There are limited data
        on the normative values expected using some devices, in a range of ages, and between ethnic
        groups.
  
        The investigators aim to establish normative values in children aged between 6 years and 12
        years, to investigate differences between ethnic groups, and to establish the relationship
        between lung clearance index and other measures of disease in children with bronchiectasis.
  
        Methods:
  
        Healthy children will be recruited from a range of settings and reviewed to ensure no
        previous lung disease. Children with bronchiectasis diagnosed on HRCT will be recruited from
        the outpatient service of Birmingham Children's Hospital.
  
        All participants will perform lung function tests including LCI and spirometry. Basic
        demographic data was collected.
  Rationale / Hypothesis:
  
        Hypothesis 1
  
        Having established normative ranges helps support interpretation of lung function testing
        which is key to their value as an investigation. With LCI, it is important to understand the
        difference that may be expected between children
  
        of different ethnic backgrounds (as demonstrated with other, non-LCI measures of lung
        function, where important differences between different ethnic groups has been found).
  
        LCI is calculated from an internally adjusted measure of an individual subject's lung volume,
        therefore potentially negating inherent differences in ethnic variation.
  
        Therefore we hypothesize that there are no differences in LCI in healthy children from
        differing ethnic backgrounds.
  
        Evidence supporting this hypothesis is not only of intellectual value, but it would also
        allow clinicians to confidently interpret a range of LCI readings using globally acquired
        normal values. Should the data not support the hypothesis, an important direction for future
        research would be established.
  
        Hypothesis 2
  
        LCI has been demonstrated to detect small differences in lung function and correlates well
        with CT imaging in some disease states. There is a paucity of data in its use in its lung
        disease outside of CF. Current availability of easy to use, repeatable and reliable devices
        allows LCI to be measured in the clinic setting (Downing et al. 2016).
  
        Understanding the relationship between CT changes and LCI in younger children with lung
        disease, would allow a non-invasive investigation (LCI) to be used to guide care and monitor
        treatment.
  
        In order to understand how LCI changes, we also intend to determine how LCI varies in
        children with Non-CF, Non-PCD Bronchiectasis over a prolonged period of time.
  
        The investigators hypothesize that in younger children with Non-CF, Non-PCD Bronchiectasis
        and evidence of milder disease on CT, LCI is a more sensitive disease marker than FEV1, and
        varies over time.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Normative values in healthy children
  time frame: 24 months
  description: The normative range of measurements of lung clearance index will be determined
  arm group label: observational
  arm group type: Experimental
  intervention type: Diagnostic Test
  intervention name: Lung Clearance Index
  description: Normative values in healthy children from ethnic backgrounds
  arm group label: observational
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: 12 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Prasad Nagakumar, MD
  role: Principal Investigator
  affiliation: Birmingham Women's and Children's Hospital
  facility: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Bronchiectasis
  sharing ipd: No