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/NCT06021912</url>
    </required_header>
    <id_info>
      <org_study_id>efficacity of EITAG</org_study_id>
      <nct_id>NCT06021912</nct_id>
    </id_info>
    <brief_title>e-ITAG Allergen Immunotherapy in the Management of Allergic Asthma</brief_title>
    <acronym>EITAG</acronym>
    <official_title>Evaluating the Efficacy of Allergen Immunotherapy in the Management of Allergic Asthma and Rhinitis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>General Administration of Military Health, Tunisia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>General Administration of Military Health, Tunisia</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Allergy is defined as a specific abnormal and excessive reaction of the immune system to&#xD;
        exposed allergen .&#xD;
  &#xD;
        This reaction is reproducible with each new exposure allergen . A recent study by The&#xD;
        European Academy of Allergy and Clinical Immunology&quot; (EAACI) estimates that 30% of the&#xD;
        population suffers from allergic rhinitis and/or conjunctivitis, 20% of children suffer from&#xD;
        asthma, and 8% of the population suffers from food allergies in Europe, with a clear increase&#xD;
        in prevalence.&#xD;
  &#xD;
        Allergenic immunotherapy (AIT) remains a corner stone in the treatment of allergic diseases.&#xD;
        It involves administering an increasing dose of allergens to induce immunological tolerance.&#xD;
        The efficacy and safety of ITA have already been demonstrated. However, patient response is&#xD;
        highly heterogeneous. This findinf illustrates the value of biomarkers in the selection of&#xD;
        patients, enabling prediction of response to ITA and follow-up.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a prospective, observationel study conducted in Pneumology Department at the Military&#xD;
        Hospital in collaboration with the Immunology Laboratory&#xD;
  &#xD;
        We followed patients in 2 groups:&#xD;
  &#xD;
        Group 1: patients with asthma or allergic rhinitis who had received allergen immunotherapy&#xD;
        (AIT). Group 2: patients with asthma or allergic rhinitis who received a conventional&#xD;
        treatment&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 1, 2023</start_date>
    <completion_date type="Anticipated">March 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Increase in IGG1, IGG4</measure>
      <time_frame>After 6 month of ITA</time_frame>
      <description>increase in IGG1, IGG4 after ITA treatment compared to conventional treatment group (prik test /ratio of IGE/IG4/ rate of significant increase is &gt; 25%.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Deacresed basophil activation</measure>
      <time_frame>After 6 month of ITA</time_frame>
      <description>activation of basophils by the presence of the CD203c marker in the ITA group compared with the conventional treatment group</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Evalution AQLQS score(QUALITY OFLIFE)</measure>
      <time_frame>After 6 month of ITA</time_frame>
      <description>Assessing the quality of life in asthma patient by AQLQS score/ ACQ/ ARIA</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Study the Efficacy of ITA in Patients With Allergic Asthma or Allergic Rhinitis or Allergic Rhinitis Compared With Conventional Treatment</condition>
    <arm_group>
      <arm_group_label>ITA GROUP</arm_group_label>
      <description>Patients with asthma or allergic rhinitis who have received allergen immunotherapy (ITA).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>STANDARD TREATMENT</arm_group_label>
      <description>patients with asthma or allergic rhinitis who have received standard allergen treatment.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Immunotherapy</intervention_name>
      <description>Sublingual immunotherapy</description>
      <arm_group_label>ITA GROUP</arm_group_label>
      <arm_group_label>STANDARD TREATMENT</arm_group_label>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Serum sample&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with symptoms of Asthma or moderate or severe persistent allergic rhinitis&#xD;
          allergic rhinitis, with a positive prick test or specific IgE&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria Patients with symptoms of Asthma or moderate or severe persistent&#xD;
          allergic rhinitis allergic rhinitis, with a positive prick test or specific IgE assay&#xD;
          demonstrating the presence of allergens (1 or 2 allergens). A significant impact on the&#xD;
          patient's quality of life Rhinitis associated with tracheitis or mild-to-moderate asthma.&#xD;
          Patients with poorly controlled asthma despite optimal treatment Ineffective drug treatment&#xD;
          Patients willing to adhere to our research protocol&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patients with multi-allergenic asthma (more than 2 allergens) Pregnancy (at the time of ITA&#xD;
          initiation). Autoimmune disease Immunosuppressive treatment Poorly controlled asthma HIV&#xD;
          infection Cancer Severe psychiatric disorders. Cardiovascular diseases with a risk of&#xD;
          complications during administration of adrenaline. Use of beta-blockers. Treatment with ACE&#xD;
          inhibitors. Persistent lesions of the oral mucosa (chronic oral aphthosis periodontitis,&#xD;
          etc.). Worsening of rhinitis. Acute febrile state. Recent administration of another vaccine&#xD;
          (in this case, the ITA should not be administered on the same day).&#xD;
  &#xD;
          ITA should not be administered on the same day).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>5 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>SELSABIL DABOUSSI, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Pneumologie</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>SELSABIL DABOUSSI, MD</last_name>
      <phone>21629424692</phone>
      <phone_ext>19358</phone_ext>
      <email>selsabilhmpit@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Military Hospital of Tunis</name>
        <address>
          <city>Tunis</city>
          <state>Montfleury</state>
          <zip>1008</zip>
          <country>Tunisia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hedi Gharsallah, MD</last_name>
        <phone>71391885</phone>
        <phone_ext>00216</phone_ext>
        <email>gharsallahhedi@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Salsabil Daboussi, MD</last_name>
        <phone>71391133</phone>
        <phone_ext>00216</phone_ext>
        <email>selsabilhmpit@gmail.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Tunisia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 26, 2023</last_update_submitted>
    <last_update_submitted_qc>August 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>General Administration of Military Health, Tunisia</investigator_affiliation>
      <investigator_full_name>Hedi Gharsallah</investigator_full_name>
      <investigator_title>DR SELSABIL Daboussi</investigator_title>
    </responsible_party>
    <keyword>ITA ASTHMA ALLERGIC RHINITIS</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Rhinitis</mesh_term>
      <mesh_term>Asthma</mesh_term>
      <mesh_term>Rhinitis, Allergic</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Immunomodulating Agents</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06021912
  org study id: efficacity of EITAG
  nct id: NCT06021912
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  Allergy is defined as a specific abnormal and excessive reaction of the immune system to
        exposed allergen .
  
        This reaction is reproducible with each new exposure allergen . A recent study by The
        European Academy of Allergy and Clinical Immunology" (EAACI) estimates that 30% of the
        population suffers from allergic rhinitis and/or conjunctivitis, 20% of children suffer from
        asthma, and 8% of the population suffers from food allergies in Europe, with a clear increase
        in prevalence.
  
        Allergenic immunotherapy (AIT) remains a corner stone in the treatment of allergic diseases.
        It involves administering an increasing dose of allergens to induce immunological tolerance.
        The efficacy and safety of ITA have already been demonstrated. However, patient response is
        highly heterogeneous. This findinf illustrates the value of biomarkers in the selection of
        patients, enabling prediction of response to ITA and follow-up.
  This is a prospective, observationel study conducted in Pneumology Department at the Military
        Hospital in collaboration with the Immunology Laboratory
  
        We followed patients in 2 groups:
  
        Group 1: patients with asthma or allergic rhinitis who had received allergen immunotherapy
        (AIT). Group 2: patients with asthma or allergic rhinitis who received a conventional
        treatment
  observational model: Case-Control
  time perspective: Cross-Sectional
  measure: Increase in IGG1, IGG4
  time frame: After 6 month of ITA
  description: increase in IGG1, IGG4 after ITA treatment compared to conventional treatment group (prik test /ratio of IGE/IG4/ rate of significant increase is > 25%.
  measure: Deacresed basophil activation
  time frame: After 6 month of ITA
  description: activation of basophils by the presence of the CD203c marker in the ITA group compared with the conventional treatment group
  measure: Evalution AQLQS score(QUALITY OFLIFE)
  time frame: After 6 month of ITA
  description: Assessing the quality of life in asthma patient by AQLQS score/ ACQ/ ARIA
  arm group label: ITA GROUP
  description: Patients with asthma or allergic rhinitis who have received allergen immunotherapy (ITA).
  arm group label: STANDARD TREATMENT
  description: patients with asthma or allergic rhinitis who have received standard allergen treatment.
  intervention type: Drug
  intervention name: Immunotherapy
  description: Sublingual immunotherapy
  arm group label: ITA GROUP
  arm group label: STANDARD TREATMENT
  Serum sample
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 5 Years
  maximum age: 65 Years
  last name: SELSABIL DABOUSSI, MD
  role: Principal Investigator
  affiliation: Pneumologie
  last name: SELSABIL DABOUSSI, MD
  phone: 21629424692
  phone ext: 19358
  email: selsabilhmpit@gmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Tunisia
  responsible party type: Principal Investigator
  investigator affiliation: General Administration of Military Health, Tunisia
  investigator full name: Hedi Gharsallah
  investigator title: DR SELSABIL Daboussi
  mesh term: Rhinitis
  mesh term: Asthma
  mesh term: Rhinitis, Allergic
  mesh term: Immunomodulating Agents
  sharing ipd: No