<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/NCT04438408</url>
  </required_header>
  <id_info>
    <org_study_id>RC31/19/0285</org_study_id>
    <nct_id>NCT04438408</nct_id>
  </id_info>
  <brief_title>National Survey on Care Pathway and Quality of Life in Patients With Severe Asthma According to Their Phenotype.</brief_title>
  <acronym>2ndsouffle</acronym>
  <official_title>National Survey on Care Pathway and Quality of Life in Patients With Severe Asthma According to Their Phenotype.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Toulouse</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>
      The SECOND SOUFFLE survey focuses on aspects of care and quality of life in a period when the&#xD;
      landscape of severe asthma is changing in the context of biotherapies. Moreover survey on&#xD;
      care pathway and quality of life of the asthmatic severe population according to their&#xD;
      phenotype have never been done. It is likely to bring results in a relatively fast time,&#xD;
      results that can lead to guide the criteria collected in RAMSES a national severe asthma&#xD;
      cohort and future research tracks of this cohort.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Th2 phenotype corresponds to severe asthmatic patients eligible for new subcutaneous&#xD;
      targeted asthma therapies, which can bring about a real improvement in symptoms and quality&#xD;
      of life. No data are available on the proportion of this patient population since the advent&#xD;
      of biotherapies, as well as the impact on quality of life and pathway by phenotype.&#xD;
&#xD;
      The survey will be conducted using a collection of data on a dedicated questionnaire&#xD;
      including validated questionnaires on the quality of life and the control of the asthmatic&#xD;
      disease as well as the therapeutic observance.&#xD;
&#xD;
      The objectives of the survey are to estimate the phenotypic profile distribution of severe&#xD;
      asthmatic patients and the proportion currently treated by biotherapies as well as the impact&#xD;
      of the pathology on the clinical profile and quality of life of patients with severe asthma.&#xD;
&#xD;
      Investigative pulmonologists selected from university or general hospitals or from private&#xD;
      practice will propose to their eligible patients to participate in the study. Patients&#xD;
      informed and not opposed to participating will complete, at the end of the consultation, the&#xD;
      dedicated questionnaire pre-filled by the pulmonologist (for the medical data required for&#xD;
      phenotypic stratification). The questionnaires will be collected from the centers and the&#xD;
      data centralized to establish the database. Analyzes will be done in order to stratify the&#xD;
      populations according to their phenotype and to analyze the data globally and by subgroup.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2021</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>Stratification of severe asthmatics in 3 phenotypes</measure>
    <time_frame>12 months</time_frame>
    <description>The severe asthmatics patients will stratified in 3 phenotypes groups: Th2 phenotype with biotherapy, Th2 phenotype without biotherapy and non-Th2 phenotype</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Asthma Chronic</condition>
  <condition>Severe Asthma</condition>
  <arm_group>
    <arm_group_label>severe asthma patient</arm_group_label>
    <description>Adult patients (≥ 18 years) with diagnosis of severe asthma for at least 12 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>questionaires</intervention_name>
    <description>patients will answer to questionnaires on the quality of life and the control of the asthmatic disease as well as the therapeutic observance.</description>
    <arm_group_label>severe asthma patient</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with confirmed diagnosis of severe asthma for at least 12 months&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of severe asthma for at least 12 months confirmed by a respiratory&#xD;
             physicians and meeting the ATS / ERS definition,&#xD;
&#xD;
          -  Social insured patient,&#xD;
&#xD;
          -  Patient given the non-opposition&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient participating in a therapeutic clinical trial&#xD;
&#xD;
          -  Patient opposing participation in this study&#xD;
&#xD;
          -  Patient with reading and comprehension difficulties not allowing him to complete the&#xD;
             questionnaires&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Didier Alain, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Toulouse</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Alain DIDIER, Pr</last_name>
    <phone>05.67.77.18.50</phone>
    <phone_ext>+33</phone_ext>
    <email>didier.a@chu-toulouse.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Isabelle OLIVIER, PhD</last_name>
    <phone>0561777051</phone>
    <phone_ext>+33</phone_ext>
    <email>olivier.i@chu-toulouse.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UHToulouse</name>
      <address>
        <city>Toulouse</city>
        <zip>31000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alain Didier, Pr</last_name>
      <phone>05 67 77 18 30</phone>
      <phone_ext>+33</phone_ext>
      <email>didier.a@chu-toulouse.fr</email>
    </contact>
    <contact_backup>
      <last_name>Isabelle OLIVIER, PhD</last_name>
      <phone>0561777051</phone>
      <phone_ext>+33</phone_ext>
      <email>olivier.i@chu-toulouse.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Alain DIDIER, Pr</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Laurent GUILLEMINAULT, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>November 3, 2020</last_update_submitted>
  <last_update_submitted_qc>November 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Severe Asthma</keyword>
  <keyword>Th2 phenotype</keyword>
  <keyword>Care pathway</keyword>
  <keyword>Quality of life</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/NCT04438408
org study id: RC31/19/0285
nct id: NCT04438408
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The SECOND SOUFFLE survey focuses on aspects of care and quality of life in a period when the
      landscape of severe asthma is changing in the context of biotherapies. Moreover survey on
      care pathway and quality of life of the asthmatic severe population according to their
      phenotype have never been done. It is likely to bring results in a relatively fast time,
      results that can lead to guide the criteria collected in RAMSES a national severe asthma
      cohort and future research tracks of this cohort.
The Th2 phenotype corresponds to severe asthmatic patients eligible for new subcutaneous
      targeted asthma therapies, which can bring about a real improvement in symptoms and quality
      of life. No data are available on the proportion of this patient population since the advent
      of biotherapies, as well as the impact on quality of life and pathway by phenotype.

      The survey will be conducted using a collection of data on a dedicated questionnaire
      including validated questionnaires on the quality of life and the control of the asthmatic
      disease as well as the therapeutic observance.

      The objectives of the survey are to estimate the phenotypic profile distribution of severe
      asthmatic patients and the proportion currently treated by biotherapies as well as the impact
      of the pathology on the clinical profile and quality of life of patients with severe asthma.

      Investigative pulmonologists selected from university or general hospitals or from private
      practice will propose to their eligible patients to participate in the study. Patients
      informed and not opposed to participating will complete, at the end of the consultation, the
      dedicated questionnaire pre-filled by the pulmonologist (for the medical data required for
      phenotypic stratification). The questionnaires will be collected from the centers and the
      data centralized to establish the database. Analyzes will be done in order to stratify the
      populations according to their phenotype and to analyze the data globally and by subgroup.
observational model: Cohort
time perspective: Prospective
measure: Stratification of severe asthmatics in 3 phenotypes
time frame: 12 months
description: The severe asthmatics patients will stratified in 3 phenotypes groups: Th2 phenotype with biotherapy, Th2 phenotype without biotherapy and non-Th2 phenotype
arm group label: severe asthma patient
description: Adult patients (≥ 18 years) with diagnosis of severe asthma for at least 12 months
intervention type: Other
intervention name: questionaires
description: patients will answer to questionnaires on the quality of life and the control of the asthmatic disease as well as the therapeutic observance.
arm group label: severe asthma patient
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Didier Alain, Pr
role: Principal Investigator
affiliation: University Hospital, Toulouse
last name: Alain DIDIER, Pr
phone: 05.67.77.18.50
phone ext: +33
email: didier.a@chu-toulouse.fr
last name: Isabelle OLIVIER, PhD
phone: 0561777051
phone ext: +33
email: olivier.i@chu-toulouse.fr
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Asthma
sharing ipd: No