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/NCT06027073</url>
    </required_header>
    <id_info>
      <org_study_id>CM-01966</org_study_id>
      <nct_id>NCT06027073</nct_id>
    </id_info>
    <brief_title>Biologics and Sublingual Immunotherapy</brief_title>
    <acronym>BSIPL</acronym>
    <official_title>Adding Biological Therapy to Asthmatic Patients on Allergen Immunotherapy to House Dust Mites</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Medical University of Silesia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Centrum Medyczne Andrzej Bożek</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Medical University of Silesia</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>
        Most current studies involve using a biological drug to increase the safety of allergen&#xD;
        immunotherapy (AIT) especially in the treatment of food allergies, to avoid the risk of&#xD;
        anaphylaxis. However, adding Xolair® to AIT may improve the therapy's effectiveness. There&#xD;
        are still few observations on this topic, especially in patients with house dust mite&#xD;
        (HDM)-driven asthma.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Assess the effectiveness of combined therapy Actair® plus Xolair compared to monotherapy with&#xD;
        Actair® or Xolair® or standard symptomatic therapy in patients with mild or moderate allergic&#xD;
        asthma to HDM.&#xD;
  &#xD;
        Treatment duration: 24 months Follow-up duration:12 months Total duration: 36 months (not&#xD;
        including screening and randomization period) May 2024 - March 2028 Consisting of a 4 to 5&#xD;
        months screening phase (with 1 month observation period prior to randomization) a treatment&#xD;
        phase of 24 months and post-treatment follow-up phase 12 months&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">May 1, 2024</start_date>
    <completion_date type="Anticipated">March 1, 2028</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2026</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>The randomization procedure with random selection will rely on computer-generated numbers using a computer program (Excel, version 14.2.0, 2020 Microsoft Corporation). The patients will be randomized into four groups 1:1:1:1 as follows:&#xD;
  Group A: Xolair® Group B: Actair® Group C: Actair® and Xolair® Group D: Standard of Care (no interventional therapy).</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Assess the effectiveness of combined therapy : omalizumab+ immunotherapy</measure>
      <time_frame>3 years</time_frame>
      <description>Daily dose of inhaled steroids (changes)</description>
    </primary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Asthma, Allergic</condition>
    <arm_group>
      <arm_group_label>omalizumab</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>standard antiasthmatic therapy and omalizumab</description>
    </arm_group>
    <arm_group>
      <arm_group_label>oral tablet HDM-immunotherapy</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>standard antiasthmatic therapy and oral immunotherapy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>combi therapy</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>standard antiasthmatic therapy and omalizumab, and oral immunotherapy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>omalizumab</intervention_name>
      <description>adding omalizumab to anti asthmatic therapy</description>
      <arm_group_label>combi therapy</arm_group_label>
      <arm_group_label>omalizumab</arm_group_label>
      <arm_group_label>oral tablet HDM-immunotherapy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:• &gt;18 years old&#xD;
  &#xD;
            -  A total IgE between 30-700 IU/mL&#xD;
  &#xD;
            -  Moderate asthma with perennial symptoms confirmed as HDM-driven asthma based on&#xD;
               medical history and positive nasal provocation tests, partially controlled asthma;&#xD;
  &#xD;
            -  FEV1 &gt;70% at baseline;&#xD;
  &#xD;
            -  Positive skin prick test results for D. pteronyssinus, D. farinae&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Sensitisation to other allergens with clinical signs not related to HDM&#xD;
  &#xD;
            -  Uncontrolled asthma,&#xD;
  &#xD;
            -  Other serious diseases or chronic unstable diseases&#xD;
  &#xD;
            -  Allergen immunotherapy during the past 5 years&#xD;
  &#xD;
            -  Contraindicating allergen immunotherapy and omalizumab treatment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Andrzej Bozek, prof</last_name>
      <phone>0048608318547</phone>
      <email>andrzejbozek@o2.pl</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>IgE</keyword>
    <keyword>asthma</keyword>
    <keyword>omalizumab</keyword>
    <keyword>immunotherapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Asthma</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Omalizumab</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>by computer database registration</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/NCT06027073
  org study id: CM-01966
  nct id: NCT06027073
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Most current studies involve using a biological drug to increase the safety of allergen
        immunotherapy (AIT) especially in the treatment of food allergies, to avoid the risk of
        anaphylaxis. However, adding Xolair® to AIT may improve the therapy's effectiveness. There
        are still few observations on this topic, especially in patients with house dust mite
        (HDM)-driven asthma.
  Assess the effectiveness of combined therapy Actair® plus Xolair compared to monotherapy with
        Actair® or Xolair® or standard symptomatic therapy in patients with mild or moderate allergic
        asthma to HDM.
  
        Treatment duration: 24 months Follow-up duration:12 months Total duration: 36 months (not
        including screening and randomization period) May 2024 - March 2028 Consisting of a 4 to 5
        months screening phase (with 1 month observation period prior to randomization) a treatment
        phase of 24 months and post-treatment follow-up phase 12 months
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The randomization procedure with random selection will rely on computer-generated numbers using a computer program (Excel, version 14.2.0, 2020 Microsoft Corporation). The patients will be randomized into four groups 1:1:1:1 as follows:
  Group A: Xolair® Group B: Actair® Group C: Actair® and Xolair® Group D: Standard of Care (no interventional therapy).
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Assess the effectiveness of combined therapy : omalizumab+ immunotherapy
  time frame: 3 years
  description: Daily dose of inhaled steroids (changes)
  arm group label: omalizumab
  arm group type: Active Comparator
  description: standard antiasthmatic therapy and omalizumab
  arm group label: oral tablet HDM-immunotherapy
  arm group type: Active Comparator
  description: standard antiasthmatic therapy and oral immunotherapy
  arm group label: combi therapy
  arm group type: Active Comparator
  description: standard antiasthmatic therapy and omalizumab, and oral immunotherapy
  arm group label: control
  arm group type: No Intervention
  intervention type: Biological
  intervention name: omalizumab
  description: adding omalizumab to anti asthmatic therapy
  arm group label: combi therapy
  arm group label: omalizumab
  arm group label: oral tablet HDM-immunotherapy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Andrzej Bozek, prof
  phone: 0048608318547
  email: andrzejbozek@o2.pl
  responsible party type: Sponsor
  mesh term: Asthma
  mesh term: Omalizumab
  sharing ipd: No
  ipd description: by computer database registration