<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/NCT03240991</url>
  </required_header>
  <id_info>
    <org_study_id>P/2016/302</org_study_id>
    <nct_id>NCT03240991</nct_id>
  </id_info>
  <brief_title>Study of Clinical, Biological Characteristics and Quality of Life of Patients With Hereditary or Acquired Non Drug-induced Bradykinin-mediated Angioedema, Monitored in Besançon's Partner Site Reference Center for Studies of Kinin-mediated Angioedema (CREAK)</brief_title>
  <acronym>QUALANGIO</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Besancon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Besancon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to describe quality of life in hereditary or acquired non drug-related&#xD;
      bradykinin-mediated angioedema patients, using validated questionnaires&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 11, 2016</start_date>
  <completion_date type="Actual">December 1, 2016</completion_date>
  <primary_completion_date type="Actual">December 1, 2016</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Dermatology Life Quality Index (DLQI)</measure>
    <time_frame>6 months</time_frame>
    <description>Description of Quality of Life (QoL) using DLQI</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Angioedema Quality of Life (AE-QoL) Questionnaire</measure>
    <time_frame>6 months</time_frame>
    <description>Description of QoL using AE-QOL questionnnaire</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">45</enrollment>
  <condition>Angioedema</condition>
  <arm_group>
    <arm_group_label>Quality of life questionnaires</arm_group_label>
    <description>Data will be collected retrospectively and prospectively.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality of life</intervention_name>
    <description>Dermatology Life Quality Index, Angioedema Quality of Life Questionnaire, Angioedema Activity Score</description>
    <arm_group_label>Quality of life questionnaires</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Hereditary or Acquired non drug-induced bradykinin-mediated angioedema patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinically documented angioedema due to C1 inhibitor deficiency, hereditary (type I et&#xD;
             II) or acquired&#xD;
&#xD;
          -  Clinically documented angioedema with normal C1 inhibitor activity (hereditary type&#xD;
             III)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acquired angioedema with normal C1 inhibitor activity (former &quot;drug-induced&quot;)&#xD;
&#xD;
          -  Minor subjects&#xD;
&#xD;
          -  Vulnerable subjects (under guardianship/curatorship/tutorship)&#xD;
&#xD;
          -  Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU Besançon</name>
      <address>
        <city>Besançon</city>
        <zip>25000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>April 13, 2018</last_update_submitted>
  <last_update_submitted_qc>April 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bradykinin-mediated angiodema</keyword>
  <keyword>quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Angioedema</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/NCT03240991
org study id: P/2016/302
nct id: NCT03240991
lead sponsor: 
has dmc: No
This study aims to describe quality of life in hereditary or acquired non drug-related
      bradykinin-mediated angioedema patients, using validated questionnaires
observational model: Case-Only
time perspective: Prospective
measure: Dermatology Life Quality Index (DLQI)
time frame: 6 months
description: Description of Quality of Life (QoL) using DLQI
measure: Angioedema Quality of Life (AE-QoL) Questionnaire
time frame: 6 months
description: Description of QoL using AE-QOL questionnnaire
arm group label: Quality of life questionnaires
description: Data will be collected retrospectively and prospectively.
intervention type: Other
intervention name: Quality of life
description: Dermatology Life Quality Index, Angioedema Quality of Life Questionnaire, Angioedema Activity Score
arm group label: Quality of life questionnaires
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Angioedema