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/NCT06041386</url>
    </required_header>
    <id_info>
      <org_study_id>219871</org_study_id>
      <nct_id>NCT06041386</nct_id>
    </id_info>
    <brief_title>REIMAGINE - Real World EvaluatIon of Mepolizumab in Severe Asthma achievinG on Treatment clinIcal remissioN, a prospEctive Study</brief_title>
    <acronym>REIMAGINE</acronym>
    <official_title>A Prospective, Real-World, Interventional Study To Evaluate The Effect Of Mepolizumab On Achieving Clinical Remission In Participants With Severe Asthma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>GlaxoSmithKline</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>GlaxoSmithKline</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a prospective, real-world, single arm, global, multi-centre study to evaluate the&#xD;
        effect of timely treatment with mepolizumab (NUCALA) to achieve clinical remission in adult&#xD;
        participants with severe asthma with an eosinophilic phenotype (SA-EP).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 16, 2023</start_date>
    <completion_date type="Anticipated">July 27, 2026</completion_date>
    <primary_completion_date type="Anticipated">July 27, 2026</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>There will be no masking in this study.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Percentage (%) of Participants Achieving 4-Component Clinical Remission</measure>
      <time_frame>At month 12</time_frame>
      <description>4-component clinical remission is defined as (a) No clinically significant asthma exacerbations (b) No OCS use for asthma (c) Well controlled asthma based on an Asthma Control Test (ACT) (d) No clinically significant deterioration of lung function.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Annualized Rates of Clinically Significant Asthma Exacerbations (CSE) and CSE Leading to Hospitalization/ Emergency Room (ER) Visits</measure>
      <time_frame>At month 12</time_frame>
      <description>CSE is defined as a deterioration in asthma requiring (1) the initiation of systemic corticosteroids and/or (2) an ER visit and/or hospital admission.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants Achieving Oral corticosteroids (OCS) Sparing Remission</measure>
      <time_frame>At month 12</time_frame>
      <description>OCS sparing is defined as (a) No clinically significant asthma exacerbations during the period of interest (b) No OCS use for asthma at the time point of interest.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants Achieving 3-Component Clinical Remission</measure>
      <time_frame>At month 12</time_frame>
      <description>3-component clinical remission is defined as (a) No clinically significant asthma exacerbations (b) No OCS use for asthma (c) Well controlled asthma based on an ACT.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean Change from Baseline in Mini-Asthma Quality of Life Questionnaire (AQLQ) Overall Score</measure>
      <time_frame>Baseline and at month 12</time_frame>
      <description>The mini-AQLQ overall score is a reduced version of the AQLQ which includes 15 items. The minimally clinically important difference (MCID) is 0.5. The response options for each item are on an equidistant scale of 7 points, where 1 corresponds to the maximum disability and 7 to the absence of disability.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">336</enrollment>
    <condition>Asthma</condition>
    <arm_group>
      <arm_group_label>All Participants</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>All participants with clinical diagnosis of Severe asthma prescribed Mepolizumab as part of routine care.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Mepolizumab</intervention_name>
      <description>Mepolizumab will be prescribed based on physician decision.</description>
      <arm_group_label>All Participants</arm_group_label>
      <other_name>NUCALA</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Spirometry</intervention_name>
      <description>Lung function via spirometry will be collected.</description>
      <arm_group_label>All Participants</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participant has a confirmed asthma diagnosis and has been prescribed NUCALA by their&#xD;
               physician for the treatment of asthma, as per local label. NUCALA can be initiated up&#xD;
               to 7 days prior to study enrollment.&#xD;
  &#xD;
            -  No NUCALA use in the 6 months prior to enrollment.&#xD;
  &#xD;
            -  Participants with greater than or equal to (≥)60 percentage (%) predicted forced&#xD;
               expiratory volume in 1 second (FEV1) and less than or equal to (≤)4 exacerbations per&#xD;
               year, as confirmed by the physician.&#xD;
  &#xD;
            -  Other local prescription criteria of NUCALA not described above at NUCALA initiation&#xD;
               (e.g., local reimbursement criteria).&#xD;
  &#xD;
            -  Written informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Investigator concerns about participant's willingness to adhere to biologic treatment&#xD;
               for any reason (e.g., cost, behavior, difficulty with access to healthcare).&#xD;
  &#xD;
            -  Participants currently on maintenance OCS.&#xD;
  &#xD;
            -  Participants using omalizumab, reslizumab, dupilumab, tezepelumab, or benralizumab&#xD;
               within the 6 months prior to enrollment.&#xD;
  &#xD;
            -  Participants participating in an interventional study with a treatment intervention.&#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>GSK Clinical Trials</last_name>
      <role>Study Director</role>
      <affiliation>GlaxoSmithKline</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>EU GSK Clinical Trials Call Center</last_name>
      <phone>+44 (0) 20 89904466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Severe asthma</keyword>
    <keyword>Eosinophilic phenotype</keyword>
    <keyword>Oral corticosteroids (OCS)</keyword>
    <keyword>Asthma exacerbations</keyword>
    <keyword>Clinical remission</keyword>
    <keyword>NUCALA</keyword>
    <keyword>Mepolizumab</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>Yes</sharing_ipd>
      <ipd_description>Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.</ipd_time_frame>
      <ipd_access_criteria>Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.</ipd_access_criteria>
      <ipd_url>https://www.gsk.com/en-gb/innovation/trials/data-transparency/</ipd_url>
    </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/NCT06041386
  org study id: 219871
  nct id: NCT06041386
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  This is a prospective, real-world, single arm, global, multi-centre study to evaluate the
        effect of timely treatment with mepolizumab (NUCALA) to achieve clinical remission in adult
        participants with severe asthma with an eosinophilic phenotype (SA-EP).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  masking description: There will be no masking in this study.
  measure: Percentage (%) of Participants Achieving 4-Component Clinical Remission
  time frame: At month 12
  description: 4-component clinical remission is defined as (a) No clinically significant asthma exacerbations (b) No OCS use for asthma (c) Well controlled asthma based on an Asthma Control Test (ACT) (d) No clinically significant deterioration of lung function.
  measure: Annualized Rates of Clinically Significant Asthma Exacerbations (CSE) and CSE Leading to Hospitalization/ Emergency Room (ER) Visits
  time frame: At month 12
  description: CSE is defined as a deterioration in asthma requiring (1) the initiation of systemic corticosteroids and/or (2) an ER visit and/or hospital admission.
  measure: Percentage of Participants Achieving Oral corticosteroids (OCS) Sparing Remission
  time frame: At month 12
  description: OCS sparing is defined as (a) No clinically significant asthma exacerbations during the period of interest (b) No OCS use for asthma at the time point of interest.
  measure: Percentage of Participants Achieving 3-Component Clinical Remission
  time frame: At month 12
  description: 3-component clinical remission is defined as (a) No clinically significant asthma exacerbations (b) No OCS use for asthma (c) Well controlled asthma based on an ACT.
  measure: Mean Change from Baseline in Mini-Asthma Quality of Life Questionnaire (AQLQ) Overall Score
  time frame: Baseline and at month 12
  description: The mini-AQLQ overall score is a reduced version of the AQLQ which includes 15 items. The minimally clinically important difference (MCID) is 0.5. The response options for each item are on an equidistant scale of 7 points, where 1 corresponds to the maximum disability and 7 to the absence of disability.
  arm group label: All Participants
  arm group type: Other
  description: All participants with clinical diagnosis of Severe asthma prescribed Mepolizumab as part of routine care.
  intervention type: Drug
  intervention name: Mepolizumab
  description: Mepolizumab will be prescribed based on physician decision.
  arm group label: All Participants
  other name: NUCALA
  intervention type: Other
  intervention name: Spirometry
  description: Lung function via spirometry will be collected.
  arm group label: All Participants
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: GSK Clinical Trials
  role: Study Director
  affiliation: GlaxoSmithKline
  last name: US GSK Clinical Trials Call Center
  phone: 877-379-3718
  email: GSKClinicalSupportHD@gsk.com
  last name: EU GSK Clinical Trials Call Center
  phone: +44 (0) 20 89904466
  email: GSKClinicalSupportHD@gsk.com
  responsible party type: Sponsor
  mesh term: Asthma
  sharing ipd: Yes
  ipd description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
  ipd access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
  ipd url: https://www.gsk.com/en-gb/innovation/trials/data-transparency/