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/NCT06026202</url>
    </required_header>
    <id_info>
      <org_study_id>326910</org_study_id>
      <nct_id>NCT06026202</nct_id>
    </id_info>
    <brief_title>Non-Eosinophilic Biological Effects of IL-5</brief_title>
    <official_title>Non-Eosinophilic Biological Effects of Interleukin 5 (IL-5) - Role of IL-5 in Suppressing Anti-Viral Immunity in Bronchial Epithelial Cells and Dendritic Cells in Asthma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Imperial College London</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Imperial College London</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>
        This study aims to investigate the role of IL-5 in suppressing anti-viral immune responses in&#xD;
        bronchial epithelial cells (BECs) and in peripheral blood mononuclear cells (PBMCs) from 5&#xD;
        people with asthma.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        IL-5 has been shown to be present in higher levels in those with asthma, more so during viral&#xD;
        infection. The investigators know from existing evidence that having increased levels of&#xD;
        interferon (IFN) reduces asthma exacerbations and viral load. The investigators suspect that&#xD;
        IL-5 reduces the immune response during viral infection in bronchial epithelial cells (BECs)&#xD;
        and peripheral blood mononuclear cells (PBMCs) by reducing levels of IFN. The aim is to&#xD;
        investigate if increased IL-5 in stable eosinophilic asthma and asthma exacerbations&#xD;
        suppresses anti-viral immunity in bronchial epithelial cells and in peripheral blood&#xD;
        mononuclear cells directly via IL-5 receptor signalling, suppressing rhinovirus induction of&#xD;
        IFNs. The investigators also will evaluate if anti-IL-5 therapies suppress IL-5&#xD;
        concentrations in stable and exacerbated asthma in vivo and whether suppression of IL-5 in&#xD;
        vivo restores deficient anti-viral immunity in BECs and PBMCs, thereby protecting against&#xD;
        asthma exacerbations.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>IL-5 suppresses anti-viral immunity in BECs and in PBMCs/pDCs directly via IL-5 receptor signalling suppressing RV induction of IFNs.</measure>
      <time_frame>1 year</time_frame>
      <description>Expression of IL-5RA, CSF2RB and IFN mRNA and protein in BECs and PBMCs will be measured at baseline and following rhinovirus infection.Viral load will be measured by PCR of viral RNA in cell lysates and virus release into supernatants by TCID50 assay to determine whether IL-5 augments virus replication.</description>
    </primary_outcome>
    <enrollment type="Anticipated">5</enrollment>
    <condition>Asthma</condition>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Peripheral blood mononuclear cells Bronchial epithelial cells&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Those with mild asthma on as required salbutamol only.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Must be eligible for the study 'Mechanisms of Adverse Effects of Long-Acting Beta-Agonists&#xD;
          in Asthma' (MAELABA) (19SM5101).&#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_contact>
      <last_name>Sebastian L Johnston, MBBS</last_name>
      <phone>+44 20 7594 3764</phone>
      <email>s.johnston@imperial.ac.uk</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Interleukin 5</keyword>
    <keyword>Bronchial epithelial cells</keyword>
    <keyword>Peripheral blood mononuclear cells</keyword>
    <keyword>Peripheral dendritic cells</keyword>
    <keyword>Interferon</keyword>
    <keyword>Rhinovirus</keyword>
    <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>
  
  
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/NCT06026202
  org study id: 326910
  nct id: NCT06026202
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to investigate the role of IL-5 in suppressing anti-viral immune responses in
        bronchial epithelial cells (BECs) and in peripheral blood mononuclear cells (PBMCs) from 5
        people with asthma.
  IL-5 has been shown to be present in higher levels in those with asthma, more so during viral
        infection. The investigators know from existing evidence that having increased levels of
        interferon (IFN) reduces asthma exacerbations and viral load. The investigators suspect that
        IL-5 reduces the immune response during viral infection in bronchial epithelial cells (BECs)
        and peripheral blood mononuclear cells (PBMCs) by reducing levels of IFN. The aim is to
        investigate if increased IL-5 in stable eosinophilic asthma and asthma exacerbations
        suppresses anti-viral immunity in bronchial epithelial cells and in peripheral blood
        mononuclear cells directly via IL-5 receptor signalling, suppressing rhinovirus induction of
        IFNs. The investigators also will evaluate if anti-IL-5 therapies suppress IL-5
        concentrations in stable and exacerbated asthma in vivo and whether suppression of IL-5 in
        vivo restores deficient anti-viral immunity in BECs and PBMCs, thereby protecting against
        asthma exacerbations.
  observational model: Other
  time perspective: Prospective
  measure: IL-5 suppresses anti-viral immunity in BECs and in PBMCs/pDCs directly via IL-5 receptor signalling suppressing RV induction of IFNs.
  time frame: 1 year
  description: Expression of IL-5RA, CSF2RB and IFN mRNA and protein in BECs and PBMCs will be measured at baseline and following rhinovirus infection.Viral load will be measured by PCR of viral RNA in cell lysates and virus release into supernatants by TCID50 assay to determine whether IL-5 augments virus replication.
  Peripheral blood mononuclear cells Bronchial epithelial cells
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Sebastian L Johnston, MBBS
  phone: +44 20 7594 3764
  email: s.johnston@imperial.ac.uk
  responsible party type: Sponsor
  mesh term: Asthma