<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/NCT03755908</url>
  </required_header>
  <id_info>
    <org_study_id>0384-18-RMB-CTIL</org_study_id>
    <nct_id>NCT03755908</nct_id>
  </id_info>
  <brief_title>Sensitivity of Forced Oscillation Technique in Children With Asthma and Normal Spirometry</brief_title>
  <official_title>Sensitivity of Forced Oscillation Technique (FOT) in Children With Asthma and Normal Spirometry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rambam Health Care Campus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rambam Health Care Campus</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>
      Exhibiting variable airway obstruction is a key factor in the diagnosis of asthma but too&#xD;
      often it is undetected by spirometry.&#xD;
&#xD;
      Study hypothesis: The forced oscillation technique (FOT) will show airway obstruction in&#xD;
      asthmatic children with normal spirometry pointing out its advantage in measuring AW&#xD;
      obstruction in this population.&#xD;
&#xD;
      We will conduct a prospective observational study in 6-18 years old children with the&#xD;
      diagnosis of asthma and a normal spirometry results.&#xD;
&#xD;
      Each subject will undergo evaluation including: asthma control questionnaire, spirometry, FOT&#xD;
      and Fractional exhaled nitric oxide (FeNO) to assess the sensitivity of FOT in diagnosing&#xD;
      airway obstruction in this circumstances.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Asthma diagnosis and control are based on history of recurrent typical symptoms&#xD;
      and variable airflow obstruction by by measuring maximal expiratory flows with spirometry.&#xD;
      However, in many children with asthma spirometry can be normal. The forced oscillation&#xD;
      technique (FOT) is a simple, noninvasive technique performed during tidal breathing that is&#xD;
      relatively easy to apply.&#xD;
&#xD;
      The objective of this study is to assess the sensitivity of FOT in children with asthma and&#xD;
      normal spirometry.&#xD;
&#xD;
      Study design: this will be a prospective observational study. Population: 6-18 years old&#xD;
      children visiting the pediatric pulmonary clinic at the investigators institution with the&#xD;
      diagnosis of asthma and normal spirometry results (FEV1 &amp; FEV1/FVC &gt;80% and FEF25-75&gt;65%)&#xD;
      either on treatment or before treatment.&#xD;
&#xD;
      Study protocol:&#xD;
&#xD;
      After obtaining written informed consent, participants will fill asthma control&#xD;
      questionnaires. Family history and risk factors for asthma will be reviewed. Data on blood&#xD;
      eosinophils and skin prick test for allergy will be collected from the medical files.&#xD;
      Medication (controller and reliever) will be also documented.&#xD;
&#xD;
      FOT will be measured using the TremoFlo C-100 Airwave Oscillometry System (Thorasys ,&#xD;
      Montreal, Quebec, Canada). R5, R20, R5-20 (resistances at the reported frequency), X5&#xD;
      (reactance at 5hz), AX5 (reactance area at 5hz), Fres (resonance frequency) will be reported.&#xD;
&#xD;
      Fractional exhaled nitric oxide (FeNO) will be measured using the single breath exhalation&#xD;
      technique.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 2018</start_date>
  <completion_date type="Anticipated">October 2021</completion_date>
  <primary_completion_date type="Anticipated">October 2020</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>R5</measure>
    <time_frame>One year</time_frame>
    <description>Resistances at the frequency of 5 hertz in kilopascal per liter per second</description>
  </primary_outcome>
  <primary_outcome>
    <measure>R20</measure>
    <time_frame>One year</time_frame>
    <description>Resistances at the frequency of 20 hertz in kilopascal per liter per second</description>
  </primary_outcome>
  <primary_outcome>
    <measure>R5-R20</measure>
    <time_frame>One year</time_frame>
    <description>The difference between R5 to R20 in kilopascal per liter per second</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Xrs 5</measure>
    <time_frame>One year</time_frame>
    <description>Reactance at the frequency of 5 hertz in kilopascal per liter</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>FeNO</measure>
    <time_frame>One year</time_frame>
    <description>Fractional exhaled Nitric Oxide (parts per billion)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Asthma in Children</condition>
  <arm_group>
    <arm_group_label>asthmatic children</arm_group_label>
    <description>Children with the diagnosis of asthma and normal spirometry results. Each subject will undergo evaluation including: asthma control questionnaire, spirometry, FOT and Fractional exhaled nitric oxide (FeNO).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Forced oscillation technique (FOT)</intervention_name>
    <description>FOT will be measured using the TremoFlo C-100 Airwave Oscillometry System (Thorasys , Montreal, Quebec, Canada). R5, R20, R5-20 (resistances in the reported frequency), X5 (reactance in 5hz) and Ax5 (reactance area in 5hz) will be reported.</description>
    <arm_group_label>asthmatic children</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children with the diagnosis of asthma and a normal spirometry results&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of asthma&#xD;
&#xD;
          -  Must be able to perform spirometry and FOT tests&#xD;
&#xD;
          -  Normal spirometry results (FEV1 &amp; FEV1/FVC &gt;80% and FEF25-75&gt;65%)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic lung disease other than asthma&#xD;
&#xD;
          -  Severe chronic medical condition such as heart failure, neuromuscular disease etc.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lea Bentur, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rambam Medical Center, Haifa, Israel</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lea Bentur, MD</last_name>
    <phone>972 4 7774360</phone>
    <email>l_bentur@rambam.health.gov.il</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Guy Gut, MD</last_name>
    <phone>972 4 7774360</phone>
    <email>g_gut@rambam.health.gov.il</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Rambam Medical Center</name>
      <address>
        <city>Haifa</city>
        <zip>32000</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>October 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 25, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>November 25, 2018</last_update_submitted>
  <last_update_submitted_qc>November 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Forced oscillation technique</keyword>
  <keyword>Airway obstruction</keyword>
  <keyword>Asthma</keyword>
  <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/NCT03755908
org study id: 0384-18-RMB-CTIL
nct id: NCT03755908
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Exhibiting variable airway obstruction is a key factor in the diagnosis of asthma but too
      often it is undetected by spirometry.

      Study hypothesis: The forced oscillation technique (FOT) will show airway obstruction in
      asthmatic children with normal spirometry pointing out its advantage in measuring AW
      obstruction in this population.

      We will conduct a prospective observational study in 6-18 years old children with the
      diagnosis of asthma and a normal spirometry results.

      Each subject will undergo evaluation including: asthma control questionnaire, spirometry, FOT
      and Fractional exhaled nitric oxide (FeNO) to assess the sensitivity of FOT in diagnosing
      airway obstruction in this circumstances.
Background: Asthma diagnosis and control are based on history of recurrent typical symptoms
      and variable airflow obstruction by by measuring maximal expiratory flows with spirometry.
      However, in many children with asthma spirometry can be normal. The forced oscillation
      technique (FOT) is a simple, noninvasive technique performed during tidal breathing that is
      relatively easy to apply.

      The objective of this study is to assess the sensitivity of FOT in children with asthma and
      normal spirometry.

      Study design: this will be a prospective observational study. Population: 6-18 years old
      children visiting the pediatric pulmonary clinic at the investigators institution with the
      diagnosis of asthma and normal spirometry results (FEV1 & FEV1/FVC >80% and FEF25-75>65%)
      either on treatment or before treatment.

      Study protocol:

      After obtaining written informed consent, participants will fill asthma control
      questionnaires. Family history and risk factors for asthma will be reviewed. Data on blood
      eosinophils and skin prick test for allergy will be collected from the medical files.
      Medication (controller and reliever) will be also documented.

      FOT will be measured using the TremoFlo C-100 Airwave Oscillometry System (Thorasys ,
      Montreal, Quebec, Canada). R5, R20, R5-20 (resistances at the reported frequency), X5
      (reactance at 5hz), AX5 (reactance area at 5hz), Fres (resonance frequency) will be reported.

      Fractional exhaled nitric oxide (FeNO) will be measured using the single breath exhalation
      technique.
observational model: Cohort
time perspective: Prospective
measure: R5
time frame: One year
description: Resistances at the frequency of 5 hertz in kilopascal per liter per second
measure: R20
time frame: One year
description: Resistances at the frequency of 20 hertz in kilopascal per liter per second
measure: R5-R20
time frame: One year
description: The difference between R5 to R20 in kilopascal per liter per second
measure: Xrs 5
time frame: One year
description: Reactance at the frequency of 5 hertz in kilopascal per liter
measure: FeNO
time frame: One year
description: Fractional exhaled Nitric Oxide (parts per billion)
arm group label: asthmatic children
description: Children with the diagnosis of asthma and normal spirometry results. Each subject will undergo evaluation including: asthma control questionnaire, spirometry, FOT and Fractional exhaled nitric oxide (FeNO).
intervention type: Device
intervention name: Forced oscillation technique (FOT)
description: FOT will be measured using the TremoFlo C-100 Airwave Oscillometry System (Thorasys , Montreal, Quebec, Canada). R5, R20, R5-20 (resistances in the reported frequency), X5 (reactance in 5hz) and Ax5 (reactance area in 5hz) will be reported.
arm group label: asthmatic children
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 18 Years
healthy volunteers: No
last name: Lea Bentur, MD
role: Principal Investigator
affiliation: Rambam Medical Center, Haifa, Israel
last name: Lea Bentur, MD
phone: 972 4 7774360
email: l_bentur@rambam.health.gov.il
last name: Guy Gut, MD
phone: 972 4 7774360
email: g_gut@rambam.health.gov.il
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Asthma
sharing ipd: No