<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/NCT02228018</url>
  </required_header>
  <id_info>
    <org_study_id>FLUI-2014-118</org_study_id>
    <nct_id>NCT02228018</nct_id>
  </id_info>
  <brief_title>The Comparison of Electronic Auscultation Coupled With CALSA and FRI; Repeatability of FRI Biomarkers</brief_title>
  <official_title>The Comparison of Electronic Auscultation Coupled With Computer Aided Lung Sound Analysis (CALSA) and Functional Respiratory Imaging (FRI) and Repeatability of FRI Biomarkers in Healthy Subjects and Asthma Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>FLUIDDA nv</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>FLUIDDA nv</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      CALSA will be compared with FRI and the repeatability of the FRI parameters will be tested in&#xD;
      a group of healthy volunteers and asthma patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      his is a study with no investigational product. CALSA will be compared with FRI and the&#xD;
      repeatability of the FRI parameters will be tested in a group of healthy volunteers and&#xD;
      asthma patients.&#xD;
&#xD;
      Electronic auscultation of respiratory sounds will be performed, lung function tests (at&#xD;
      maximal dilatation) will be executed and computed tomography (CT) scans of the thorax will be&#xD;
      taken. The scans will be taken at two different breathing levels, more specifically at total&#xD;
      lung capacity (TLC) and functional residual capacity (FRC) level. The scans will be taken&#xD;
      while the patient/ volunteer lies down on the movable table of the CT-scan. After the scan is&#xD;
      taken it will be asked to the patient/ volunteer to sit upright on the scanning table and to&#xD;
      lie down again. When the patient/ volunteer lies down a second CT-scan (TLC and FRC) will be&#xD;
      taken.&#xD;
&#xD;
      The objective of this study is to compare CALSA with FRI and to assess the repeatability of&#xD;
      FRI biomarkers&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Other strategies followed&#xD;
  </why_stopped>
  <start_date>March 2015</start_date>
  <completion_date type="Anticipated">January 2016</completion_date>
  <primary_completion_date type="Anticipated">January 2016</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>CALSA</measure>
    <time_frame>1 day</time_frame>
    <description>The primary objective of this study is to compare CALSA with FRI. The respiratory sounds recordings are performed with a digital stethoscope and connected to the sound card of a laptop with commercial software, suitable for data acquisition. The respiratory sounds recordings are conducted in accordance with the Computerized Respiratory Sound Analysis guidelines (CORSA) for short-term acquisition. Subjects are asked to breathe through the mouth in a sitting position (tidal breathing) during the recordings. Three sets of recordings are made for 7 - 10 respiratory cycles with a maximum duration of 25 seconds.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total Airway Volume (iVaw)</measure>
    <time_frame>1 day</time_frame>
    <description>The secondary objective is to check the repeatability of the FRI parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Airway Resistance (iRaw)</measure>
    <time_frame>1 day</time_frame>
    <description>The secondary objective is to check the repeatability of the FRI parameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Internal Airway Distribution</measure>
    <time_frame>1 day</time_frame>
    <description>The secondary objective is to check the repeatability of the FRI parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lobar Volume</measure>
    <time_frame>1 day</time_frame>
    <description>The secondary objective is to check the repeatability of the FRI parameters</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>CALSA and FRI repeatability</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CT-Scan No medication used</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CT-scan</intervention_name>
    <description>CT-Scan will be taken at visit 1 on FRC and TLC breathing levels</description>
    <arm_group_label>CALSA and FRI repeatability</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female patient / volunteer ≥ 18 years old&#xD;
&#xD;
          -  Written informed consent obtained&#xD;
&#xD;
          -  The subject belongs to 1 of the following groups in the opinion of the investigator:&#xD;
&#xD;
        Group 1: healthy volunteer Group 2: patient with asthma&#xD;
&#xD;
          -  Only if patient/ volunteer is a female of childbearing potential: Confirmation that a&#xD;
             contraception method was used at least 14 days before visit 1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating female&#xD;
&#xD;
          -  Patient/ volunteer with an uncontrolled disease or any condition that might, in the&#xD;
             judgement of the investigator, place the patient at undue risk or potentially&#xD;
             compromise the results or interpretation of the study.&#xD;
&#xD;
        Patient/ volunteer with an uncontrolled disease or any condition that might, in the&#xD;
        judgement of the investigator, place the patient at undue risk or potentially compromise&#xD;
        the results or interpretation of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wilfried De Backer, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Antwerp</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Antwerp University Hospital</name>
      <address>
        <city>Edegem</city>
        <state>Antwerp</state>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <last_update_submitted>February 2, 2016</last_update_submitted>
  <last_update_submitted_qc>February 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 3, 2016</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>Asthma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02228018
org study id: FLUI-2014-118
nct id: NCT02228018
lead sponsor: 
has dmc: Yes
CALSA will be compared with FRI and the repeatability of the FRI parameters will be tested in
      a group of healthy volunteers and asthma patients.
his is a study with no investigational product. CALSA will be compared with FRI and the
      repeatability of the FRI parameters will be tested in a group of healthy volunteers and
      asthma patients.

      Electronic auscultation of respiratory sounds will be performed, lung function tests (at
      maximal dilatation) will be executed and computed tomography (CT) scans of the thorax will be
      taken. The scans will be taken at two different breathing levels, more specifically at total
      lung capacity (TLC) and functional residual capacity (FRC) level. The scans will be taken
      while the patient/ volunteer lies down on the movable table of the CT-scan. After the scan is
      taken it will be asked to the patient/ volunteer to sit upright on the scanning table and to
      lie down again. When the patient/ volunteer lies down a second CT-scan (TLC and FRC) will be
      taken.

      The objective of this study is to compare CALSA with FRI and to assess the repeatability of
      FRI biomarkers
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: CALSA
time frame: 1 day
description: The primary objective of this study is to compare CALSA with FRI. The respiratory sounds recordings are performed with a digital stethoscope and connected to the sound card of a laptop with commercial software, suitable for data acquisition. The respiratory sounds recordings are conducted in accordance with the Computerized Respiratory Sound Analysis guidelines (CORSA) for short-term acquisition. Subjects are asked to breathe through the mouth in a sitting position (tidal breathing) during the recordings. Three sets of recordings are made for 7 - 10 respiratory cycles with a maximum duration of 25 seconds.
measure: Total Airway Volume (iVaw)
time frame: 1 day
description: The secondary objective is to check the repeatability of the FRI parameters
measure: Total Airway Resistance (iRaw)
time frame: 1 day
description: The secondary objective is to check the repeatability of the FRI parameters.
measure: Internal Airway Distribution
time frame: 1 day
description: The secondary objective is to check the repeatability of the FRI parameters
measure: Lobar Volume
time frame: 1 day
description: The secondary objective is to check the repeatability of the FRI parameters
arm group label: CALSA and FRI repeatability
arm group type: Experimental
description: CT-Scan No medication used
intervention type: Device
intervention name: CT-scan
description: CT-Scan will be taken at visit 1 on FRC and TLC breathing levels
arm group label: CALSA and FRI repeatability
criteria: 
gender: All
minimum age: 18 Years
maximum age: 120 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Wilfried De Backer, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Antwerp
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Asthma
sharing ipd: No