<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/NCT02195258</url>
  </required_header>
  <id_info>
    <org_study_id>URC Paris centre</org_study_id>
    <nct_id>NCT02195258</nct_id>
  </id_info>
  <brief_title>Pharmacogenetic of Salbutamol in Pediatric Asthma Crisis</brief_title>
  <acronym>Pegase</acronym>
  <official_title>Pharmacogenetic of the Salbutamol Efficacy in Asthma Crisis for Children in Emergency Department</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hôpital Necker-Enfants Malades</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hôpital Necker-Enfants Malades</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      this study is designed to identify the genetic factors which can be implicated in the&#xD;
      salbutamol responsiveness for asthmatic children in pediatric emergency department&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients from 6 to 16 years old consulting for an acute asthma exacerbation and receiving a&#xD;
      treatment by salbutamol according to the usual care could be recruited.Saliva from patient&#xD;
      were collected using Oragen®.DNA OG-500 kit or swabs.Based on literature review, four SNP&#xD;
      were chosen:ADBR2 gene), ARG gene, and GSNOR gene.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2010</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">May 2012</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>pre- and post-bronchodilator FEV1 value (BDR = 100 x [post-FEV1 - pre-FEV1]/pre-FEV1)</measure>
    <time_frame>Day 0</time_frame>
    <description>comparison of acute response to salbutamol calculated as the percentage difference between the pre- and post-bronchodilator FEV1 value (BDR = 100 x [post-FEV1 - pre-FEV1]/pre-FEV1) between the different polymorphism</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>polymorphism on the response delay</measure>
    <time_frame>Day 0</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">95</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>salbutamol</arm_group_label>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Saliva from patient were collected using Oragen®.DNA OG-500 kit, (DNA Genotek, Kanata,&#xD;
      Canada) or swabs (Catch-All™ sample collection swabs from Epicentre Biotechnologies, Madison,&#xD;
      WI), and stored at room temperature or -20°C, respectively.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        children 6-16 years old asthmatic patients consulting for an exacerbation in a pediatric&#xD;
        emergency department&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children&#xD;
&#xD;
          -  6-16 years old&#xD;
&#xD;
          -  asthmatic patients&#xD;
&#xD;
          -  consulting for an exacerbation in a pediatric emergency department&#xD;
&#xD;
          -  parental informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  comorbidity&#xD;
&#xD;
          -  peak flow no available&#xD;
&#xD;
          -  pneumonia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hélène Chappuy, MDPhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>APHP</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Necker Enfants Malades Hospital</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2013</verification_date>
  <study_first_submitted>July 4, 2013</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>July 17, 2014</last_update_submitted>
  <last_update_submitted_qc>July 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 21, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hôpital Necker-Enfants Malades</investigator_affiliation>
    <investigator_full_name>Helene Chappuy</investigator_full_name>
    <investigator_title>MD Ph D</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <!-- 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/NCT02195258
org study id: URC Paris centre
nct id: NCT02195258
lead sponsor: 
has dmc: Yes
this study is designed to identify the genetic factors which can be implicated in the
      salbutamol responsiveness for asthmatic children in pediatric emergency department
Patients from 6 to 16 years old consulting for an acute asthma exacerbation and receiving a
      treatment by salbutamol according to the usual care could be recruited.Saliva from patient
      were collected using Oragen®.DNA OG-500 kit or swabs.Based on literature review, four SNP
      were chosen:ADBR2 gene), ARG gene, and GSNOR gene.
observational model: Case-Only
time perspective: Prospective
measure: pre- and post-bronchodilator FEV1 value (BDR = 100 x [post-FEV1 - pre-FEV1]/pre-FEV1)
time frame: Day 0
description: comparison of acute response to salbutamol calculated as the percentage difference between the pre- and post-bronchodilator FEV1 value (BDR = 100 x [post-FEV1 - pre-FEV1]/pre-FEV1) between the different polymorphism
measure: polymorphism on the response delay
time frame: Day 0
arm group label: salbutamol
Saliva from patient were collected using Oragen®.DNA OG-500 kit, (DNA Genotek, Kanata,
      Canada) or swabs (Catch-All™ sample collection swabs from Epicentre Biotechnologies, Madison,
      WI), and stored at room temperature or -20°C, respectively.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 16 Years
healthy volunteers: No
last name: Hélène Chappuy, MDPhD
role: Principal Investigator
affiliation: APHP
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Hôpital Necker-Enfants Malades
investigator full name: Helene Chappuy
investigator title: MD Ph D
mesh term: Asthma