<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/NCT03814018</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL19_0007</org_study_id>
    <nct_id>NCT03814018</nct_id>
  </id_info>
  <brief_title>Bronchoreversibility Test in Asthmatic Children and Correlation With Diagnostic Criteria Proposed by the GINA Guidelines</brief_title>
  <acronym>VERI-VEMS</acronym>
  <official_title>A Retrospective Study to Verify FEV1 Reversibility Criteria Proposed by the GINA Guidelines, in Asthmatic Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</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>
      Since 2015, GINA (Global INitiative on Asthma) guidelines were modified and adapted to better&#xD;
      fit the pediatric population. Asthma diagnosis is mainly based on the results of PFT&#xD;
      (Pulmonary Function Tests) and broncho-reversibility test in adult. GINA guidelines modified&#xD;
      the requirements to reach a diagnosis of Asthma in children, based on the reversibility test.&#xD;
      GINA guideline propose an increase of 12% of the FEV1 is considered as the diagnostic&#xD;
      criterium for asthma in pediatrics.&#xD;
&#xD;
      Nevertheless, in clinical practice, most physicians base their diagnosis of asthma in&#xD;
      children on the clinical signs presented by the patient and on the efficacy of the prescribed&#xD;
      therapy. Also, the spirometric criterium is not sufficiently corroborated by clinical&#xD;
      studies. No research has ever looked for the results of bronchoreversibility test in patients&#xD;
      receiving a clinical diagnosis of asthma. For this reason, in children with a clinical&#xD;
      diagnosis of asthma, the investigators want to look for the results of the&#xD;
      bronchoreversibility test and validate that an increase of 12% of the FEV1 correlate with a&#xD;
      physician-driven diagnosis of asthma in pediatrics. For further analysis the&#xD;
      investigatorswill evaluate also the reversibility of small airways (FEF25-75) and the z-score&#xD;
      of the results of the PFT in these children.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">October 30, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>value of FEV1 increase</measure>
    <time_frame>1 day</time_frame>
    <description>Positive predictive value of FEV1 increase (%) in asthmatic children after bronchodilation test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>value of FEF 25-75</measure>
    <time_frame>1 day</time_frame>
    <description>Positive predictive value of FEF 25-75 increase (%) in asthmatic children after bronchodilation test</description>
  </primary_outcome>
  <enrollment type="Actual">600</enrollment>
  <condition>Pediatric Asthma</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Children with a physician-base diagnosis of asthma, undergoing a bronchodilation test&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Children aged between 5 and 18 years&#xD;
&#xD;
          -  Children with a diagnosis of asthma undergoing a PFT and a bronchoreversibility test&#xD;
             on the day of the diagnosis&#xD;
&#xD;
          -  Children evaluated at the University Hospital of Montpellier (France), or at the&#xD;
             Pediatric Allergy Unit of the University Hospital of Pavia (Italy)&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Children not able to perform a PFT&#xD;
&#xD;
          -  Children taking drugs that could affect the results of a PFT&#xD;
&#xD;
          -  Children included in other trials that don't allow them to be included in the present&#xD;
             one&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Davide CAIMMI</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uhmontpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>January 21, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>November 18, 2019</last_update_submitted>
  <last_update_submitted_qc>November 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bronchodilation test</keyword>
  <keyword>GINA</keyword>
  <keyword>Reversibility criteria</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>Undecided</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/NCT03814018
org study id: RECHMPL19_0007
nct id: NCT03814018
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Since 2015, GINA (Global INitiative on Asthma) guidelines were modified and adapted to better
      fit the pediatric population. Asthma diagnosis is mainly based on the results of PFT
      (Pulmonary Function Tests) and broncho-reversibility test in adult. GINA guidelines modified
      the requirements to reach a diagnosis of Asthma in children, based on the reversibility test.
      GINA guideline propose an increase of 12% of the FEV1 is considered as the diagnostic
      criterium for asthma in pediatrics.

      Nevertheless, in clinical practice, most physicians base their diagnosis of asthma in
      children on the clinical signs presented by the patient and on the efficacy of the prescribed
      therapy. Also, the spirometric criterium is not sufficiently corroborated by clinical
      studies. No research has ever looked for the results of bronchoreversibility test in patients
      receiving a clinical diagnosis of asthma. For this reason, in children with a clinical
      diagnosis of asthma, the investigators want to look for the results of the
      bronchoreversibility test and validate that an increase of 12% of the FEV1 correlate with a
      physician-driven diagnosis of asthma in pediatrics. For further analysis the
      investigatorswill evaluate also the reversibility of small airways (FEF25-75) and the z-score
      of the results of the PFT in these children.
observational model: Case-Only
time perspective: Retrospective
measure: value of FEV1 increase
time frame: 1 day
description: Positive predictive value of FEV1 increase (%) in asthmatic children after bronchodilation test
measure: value of FEF 25-75
time frame: 1 day
description: Positive predictive value of FEF 25-75 increase (%) in asthmatic children after bronchodilation test
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: 18 Years
healthy volunteers: No
last name: Davide CAIMMI
role: Principal Investigator
affiliation: University Hospital, Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: Asthma
sharing ipd: Undecided