<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/NCT03025061</url>
  </required_header>
  <id_info>
    <org_study_id>5/2016</org_study_id>
    <nct_id>NCT03025061</nct_id>
  </id_info>
  <brief_title>Within-day and Between-day Repeatability of the Breath Pattern in Healthy Children and in Children With Asthma</brief_title>
  <acronym>CERS</acronym>
  <official_title>Within-day and Between-day Repeatability of the Breath Pattern in Healthy Children and in Children With Moderate Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto per la Ricerca e l'Innovazione Biomedica</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Campus Bio-Medico University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Istituto per la Ricerca e l'Innovazione Biomedica</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      &quot;Within-day and Between-day Repeatability of the Breath Pattern in Healthy Children and in&#xD;
      Children With Moderate Asthma&quot; is an observational prospective study in outpatient clinic of&#xD;
      Pediatric Allergology &amp; Pulmonology (PAP) within the Institute of Biomedicine and Molecular&#xD;
      Immunology (IBIM) of the National Research Council (CNR) of Palermo (IBIM CNR), Italy.&#xD;
&#xD;
      The electronic nose (E-nose) has been proposed as a novel, non-invasive tool to evaluate the&#xD;
      level of airway inflammation for different respiratory diseases, especially in children. To&#xD;
      date, there are no data on the within-day and the between-day repeatability of the breath&#xD;
      pattern in healthy children and in children with moderate asthma.&#xD;
&#xD;
      The breath pattern will be analyzed by collecting, for each child, three samples of the&#xD;
      breath through the E-nose. Within-day repeatability will be assessed using two consecutive&#xD;
      measurements (the second one after 30 minutes). Between-day repeatability will be assessed&#xD;
      using a third measurement repeated after 7 days.&#xD;
&#xD;
      The study is expected to provide information about the accuracy of E-nose measurements for a&#xD;
      child population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 24, 2017</start_date>
  <completion_date type="Actual">August 3, 2018</completion_date>
  <primary_completion_date type="Actual">August 3, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Electronic nose measurements</measure>
    <time_frame>1 week</time_frame>
    <description>Several volatile organic compounds, including isoprene, 1,2-pentadiene, acetone, ethanol, pentane and ethane, identified in exhaled breath.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fraction of Exhaled Nitric Oxide (FeNO)</measure>
    <time_frame>1 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary function (FEV1, FVC, etc.)</measure>
    <time_frame>1 week</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">45</enrollment>
  <condition>Asthma</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>15 children with moderate asthma</arm_group_label>
    <description>Assessment of E-nose measurements: three E-nose measurements on 15 children with moderate asthma (of both sex and 6-11 years old): first measurement, second one after 30 minutes, third one after 7 days. These children attend the outpatient clinic of Pediatric Allergology &amp; Pulmonology (PAP) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (IBIM CNR).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>30 healthy children</arm_group_label>
    <description>Assessment of E-nose measurements: three E-nose measurements on 30 healthy children (of both sex and 6-11 years old): first measurement, second one after 30 minutes, third one after 7 days. These children attend the primary schools involved in the municipal project &quot;Educational Pathways&quot; (Palermo).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Assessment of E-nose measurements</intervention_name>
    <description>Breath sampling through E-nose pneumopipe</description>
    <arm_group_label>15 children with moderate asthma</arm_group_label>
    <arm_group_label>30 healthy children</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A study population of 15 asthmatic children (moderate asthma) attending the outpatient&#xD;
        clinic of Pediatric Allergology &amp; Pulmonology (PAP) within the Institute of Biomedicine and&#xD;
        Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (IBIM CNR).&#xD;
&#xD;
        A control group of healthy children (n=30), recruited from the primary schools involved in&#xD;
        the municipal project &quot;educational pathways&quot; (Palermo, Italy) to which the PAP group&#xD;
        partecipates.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        The inclusion criteria for asthmatic children are:&#xD;
&#xD;
          1. Moderate asthma (GINA 2015);&#xD;
&#xD;
          2. Age 6-11 years;&#xD;
&#xD;
          3. No upper airway respiratory infections or exacerbations in the last 4 weeks;&#xD;
&#xD;
          4. Steroid-naive asthma;&#xD;
&#xD;
          5. Positive bronchodilator response;&#xD;
&#xD;
          6. Non smoker.&#xD;
&#xD;
        The inclusion criteria for healthy children are:&#xD;
&#xD;
          1. Age 6-11 years;&#xD;
&#xD;
          2. No upper airway respiratory infections in the last 4 weeks;&#xD;
&#xD;
          3. Non smoker;&#xD;
&#xD;
          4. No history of asthma and respiratory diseases during the life;&#xD;
&#xD;
          5. Negative bronchodilator response.&#xD;
&#xD;
        The exclusion criteria are:&#xD;
&#xD;
          1. Symptoms of acute respiratory infection;&#xD;
&#xD;
          2. Immunological and metabolic systemic disease;&#xD;
&#xD;
          3. Major malformations of the upper airways;&#xD;
&#xD;
          4. Active smoker.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council</name>
      <address>
        <city>Palermo</city>
        <state>Sicily</state>
        <zip>90146</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>September 3, 2018</last_update_submitted>
  <last_update_submitted_qc>September 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istituto per la Ricerca e l'Innovazione Biomedica</investigator_affiliation>
    <investigator_full_name>Stefania La Grutta, MD</investigator_full_name>
    <investigator_title>MD. Senior Researcher. Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.</investigator_title>
  </responsible_party>
  <keyword>Breath pattern</keyword>
  <keyword>Children</keyword>
  <keyword>Repeatability</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/NCT03025061
org study id: 5/2016
nct id: NCT03025061
lead sponsor: 
collaborator: 
has dmc: Yes
"Within-day and Between-day Repeatability of the Breath Pattern in Healthy Children and in
      Children With Moderate Asthma" is an observational prospective study in outpatient clinic of
      Pediatric Allergology & Pulmonology (PAP) within the Institute of Biomedicine and Molecular
      Immunology (IBIM) of the National Research Council (CNR) of Palermo (IBIM CNR), Italy.

      The electronic nose (E-nose) has been proposed as a novel, non-invasive tool to evaluate the
      level of airway inflammation for different respiratory diseases, especially in children. To
      date, there are no data on the within-day and the between-day repeatability of the breath
      pattern in healthy children and in children with moderate asthma.

      The breath pattern will be analyzed by collecting, for each child, three samples of the
      breath through the E-nose. Within-day repeatability will be assessed using two consecutive
      measurements (the second one after 30 minutes). Between-day repeatability will be assessed
      using a third measurement repeated after 7 days.

      The study is expected to provide information about the accuracy of E-nose measurements for a
      child population.
observational model: Other
time perspective: Prospective
measure: Electronic nose measurements
time frame: 1 week
description: Several volatile organic compounds, including isoprene, 1,2-pentadiene, acetone, ethanol, pentane and ethane, identified in exhaled breath.
measure: Fraction of Exhaled Nitric Oxide (FeNO)
time frame: 1 week
measure: Pulmonary function (FEV1, FVC, etc.)
time frame: 1 week
arm group label: 15 children with moderate asthma
description: Assessment of E-nose measurements: three E-nose measurements on 15 children with moderate asthma (of both sex and 6-11 years old): first measurement, second one after 30 minutes, third one after 7 days. These children attend the outpatient clinic of Pediatric Allergology & Pulmonology (PAP) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (IBIM CNR).
arm group label: 30 healthy children
description: Assessment of E-nose measurements: three E-nose measurements on 30 healthy children (of both sex and 6-11 years old): first measurement, second one after 30 minutes, third one after 7 days. These children attend the primary schools involved in the municipal project "Educational Pathways" (Palermo).
intervention type: Other
intervention name: Assessment of E-nose measurements
description: Breath sampling through E-nose pneumopipe
arm group label: 15 children with moderate asthma
arm group label: 30 healthy children
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 11 Years
healthy volunteers: No
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Istituto per la Ricerca e l'Innovazione Biomedica
investigator full name: Stefania La Grutta, MD
investigator title: MD. Senior Researcher. Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.
mesh term: Asthma
sharing ipd: No