xml: <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/NCT06018441</url>
    </required_header>
    <id_info>
      <org_study_id>OBS17526</org_study_id>
      <secondary_id>U1111-1279-3274</secondary_id>
      <nct_id>NCT06018441</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate the Quality of Life in Male and Female Adult Participants With Severe Asthma Treated With Dupilumab in a Real-world Setting</brief_title>
    <acronym>PROVERB</acronym>
    <official_title>National, Multicenter, Non-interventional, Prospective Study to Explore the Quality of Life of Patients With Severe Asthma Starting Treatment With Dupilumab (Dupixent®) in a Real-world Setting</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sanofi</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sanofi</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
    </oversight_info>
    <brief_summary>
      <textblock>
        Primary Objective:&#xD;
  &#xD;
        - To describe dupilumab health-related quality of life (HRQoL) effectiveness at 52 weeks&#xD;
        compared to baseline.&#xD;
  &#xD;
        Secondary Objectives:&#xD;
  &#xD;
          -  To describe dupilumab HRQoL effectiveness at 12 and 24 weeks compared to baseline.&#xD;
  &#xD;
          -  To assess the safety during the year of treatment in a real-world setting.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 4, 2023</start_date>
    <completion_date type="Anticipated">September 8, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 8, 2025</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>Change from baseline in health-related quality of life (HRQoL), as measured by the St. George's Respiratory Questionnaire (SGRQ)</measure>
      <time_frame>Baseline (Day 0), Week 52</time_frame>
      <description>The SGRQ is a 50-item questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation. A global score ranges from 0 to 100. Scores by dimension are calculated for 3 domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. A lower score indicates better quality of life.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in health-related quality of life (HRQoL), as measured by the St. George's Respiratory Questionnaire (SGRQ)</measure>
      <time_frame>Baseline (Day 0), Week 12 and Week 24</time_frame>
      <description>The SGRQ is a 50-item questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation. A global score ranges from 0 to 100. Scores by dimension are calculated for 3 domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. A lower score indicates better quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with adverse events (AEs)</measure>
      <time_frame>Day 0 to Week 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with serious adverse events (SAEs)</measure>
      <time_frame>Day 0 to Week 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with adverse events of special interest</measure>
      <time_frame>Day 0 to Week 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with medication errors</measure>
      <time_frame>Day 0 to Week 52</time_frame>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Asthma</condition>
    <arm_group>
      <arm_group_label>Severe asthma</arm_group_label>
      <description>Participants with severe asthma starting treatment with dupilumab</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Participants with severe asthma&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participant must be at least 18 years of age inclusive, at the time of signing the&#xD;
               informed consent.&#xD;
  &#xD;
            -  Participant for whom decision of initiation and prescription of dupilumab (Dupixent®)&#xD;
               for the severe uncontrolled asthma indication was made by the investigator within four&#xD;
               weeks before the inclusion in the study. Oral CorticoSteroid (OCS) or&#xD;
               non-OCS-dependent patient could be included.&#xD;
  &#xD;
            -  Participant for whom St. George's Respiratory Questionnaire (SGRQ) score is available&#xD;
               within the last 4 weeks prior to dupilumab initiation. SGRQ score could be collected&#xD;
               at baseline visit for participants who have not yet started dupilumab.&#xD;
  &#xD;
            -  Capable of giving signed informed consent which includes compliance with the&#xD;
               requirements and restrictions listed in the informed consent form (ICF) and in this&#xD;
               protocol.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participant below 18 years of age. - Participant participating in a clinical trial at&#xD;
               the time of enrolment.&#xD;
  &#xD;
            -  Participant under guardianship, trusteeship or under judicial protection. The above&#xD;
               information is not intended to contain all considerations relevant to a potential&#xD;
               participation in a clinical trial.&#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>Clinical Sciences &amp;amp; Operations</last_name>
      <role>Study Director</role>
      <affiliation>Sanofi</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Trial Transparency email recommended (Toll free for US &amp;amp; Canada)</last_name>
      <phone>800-633-1610</phone>
      <phone_ext>option 6</phone_ext>
      <email>Contact-US@sanofi.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Asthma</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06018441
  org study id: OBS17526
  secondary id: U1111-1279-3274
  nct id: NCT06018441
  lead sponsor: 
  has dmc: No
  Primary Objective:
  
        - To describe dupilumab health-related quality of life (HRQoL) effectiveness at 52 weeks
        compared to baseline.
  
        Secondary Objectives:
  
          -  To describe dupilumab HRQoL effectiveness at 12 and 24 weeks compared to baseline.
  
          -  To assess the safety during the year of treatment in a real-world setting.
  observational model: Cohort
  time perspective: Prospective
  measure: Change from baseline in health-related quality of life (HRQoL), as measured by the St. George's Respiratory Questionnaire (SGRQ)
  time frame: Baseline (Day 0), Week 52
  description: The SGRQ is a 50-item questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation. A global score ranges from 0 to 100. Scores by dimension are calculated for 3 domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. A lower score indicates better quality of life.
  measure: Change from baseline in health-related quality of life (HRQoL), as measured by the St. George's Respiratory Questionnaire (SGRQ)
  time frame: Baseline (Day 0), Week 12 and Week 24
  description: The SGRQ is a 50-item questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation. A global score ranges from 0 to 100. Scores by dimension are calculated for 3 domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. A lower score indicates better quality of life.
  measure: Number of participants with adverse events (AEs)
  time frame: Day 0 to Week 52
  measure: Number of participants with serious adverse events (SAEs)
  time frame: Day 0 to Week 52
  measure: Number of participants with adverse events of special interest
  time frame: Day 0 to Week 52
  measure: Number of participants with medication errors
  time frame: Day 0 to Week 52
  arm group label: Severe asthma
  description: Participants with severe asthma starting treatment with dupilumab
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Clinical Sciences &amp; Operations
  role: Study Director
  affiliation: Sanofi
  last name: Trial Transparency email recommended (Toll free for US &amp; Canada)
  phone: 800-633-1610
  phone ext: option 6
  email: Contact-US@sanofi.com
  responsible party type: Sponsor
  mesh term: Asthma
  sharing ipd: Yes
  ipd description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org