<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/NCT03019237</url>
  </required_header>
  <id_info>
    <org_study_id>2012-004193-25</org_study_id>
    <nct_id>NCT03019237</nct_id>
  </id_info>
  <brief_title>Effect of Intranasal Anti-IgE Antibodies on IgE Production</brief_title>
  <official_title>The Effect of Intranasal Application of Anti-IgE Antibodies on IgE Production in Patients Suffering From Seasonal Allergic Rhinitis - a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, participants will receive either intranasal anti-IgE-antibodies (n=5) or&#xD;
      intranasal allergen (n=5) or intranasal placebo (n=5). Blood samples will be obtained before&#xD;
      nasal administration of study drugs and 3, 5 and 8 weeks thereafter. In the serum samples,&#xD;
      specific and total IgE levels will be assessed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The intranasal challenge study will be performed over 8 weeks outside of the birch pollen&#xD;
      season (November to January) as a randomized, double blind and placebo-controlled study.&#xD;
      During a screening visit, 15 individuals will be recruited according to eligibility criteria.&#xD;
      They will be randomized into 3 groups (i.n. administration of anti-IgE antibodies, Bet v 1 or&#xD;
      placebo). Intranasal administration will take place on three consecutive days and serum&#xD;
      samples will be taken 3, 5, and 8 weeks (+/- 4 days) after the treatment for analysis of&#xD;
      total and specific IgE levels&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change of allergen-specific IgE</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>changes in total IgE</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Allergy</condition>
  <arm_group>
    <arm_group_label>intranasal anti-IgE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Anti-IgE (Xolair) will be freshly diluted in sterile 0.9% sodium chloride solution (438 μg/ml) and will be administered using a metered pump delivering 15 μl per puff to both nostrils on three consecutive days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>intranasal allergen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>GMP produced rBet v 1 will be freshly diluted in sterile 0.9% sodium chloride solution (50 μg/ml) and will be administered using a metered pump delivering 15 μl per puff to both nostrils on three consecutive days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>intranasal saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Sterile 0.9% sodium chloride solution will be administered using a metered pump delivering 15 μl per puff to both nostrils on three consecutive days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>anti-IgE</intervention_name>
    <description>intranasal anti-IgE</description>
    <arm_group_label>intranasal anti-IgE</arm_group_label>
    <other_name>Omalizumab</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>intranasal allergen</intervention_name>
    <description>intranasal allergen</description>
    <arm_group_label>intranasal allergen</arm_group_label>
    <other_name>GMP produced recombinant Bet v 1</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>intranasal saline</intervention_name>
    <description>intranasal placebo</description>
    <arm_group_label>intranasal saline</arm_group_label>
    <other_name>sodium chloride 0.9%</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        birch pollen allergy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        history of anaphylaxis autoimmune diseases treatment with corticosteroids, antihistamines,&#xD;
        immunosuppressant drugs, beta-blockers significant medical conditions pregnancy or&#xD;
        lactation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Verena Niederberger, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Vienna</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dept. of Otorhinolaryngology, Medical University of Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>A-1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>January 10, 2017</last_update_submitted>
  <last_update_submitted_qc>January 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Verena Niederberger-Leppin</investigator_full_name>
    <investigator_title>ao. Univ.-Prof. Dr.</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Omalizumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03019237
org study id: 2012-004193-25
nct id: NCT03019237
lead sponsor: 
has dmc: No
In this study, participants will receive either intranasal anti-IgE-antibodies (n=5) or
      intranasal allergen (n=5) or intranasal placebo (n=5). Blood samples will be obtained before
      nasal administration of study drugs and 3, 5 and 8 weeks thereafter. In the serum samples,
      specific and total IgE levels will be assessed.
The intranasal challenge study will be performed over 8 weeks outside of the birch pollen
      season (November to January) as a randomized, double blind and placebo-controlled study.
      During a screening visit, 15 individuals will be recruited according to eligibility criteria.
      They will be randomized into 3 groups (i.n. administration of anti-IgE antibodies, Bet v 1 or
      placebo). Intranasal administration will take place on three consecutive days and serum
      samples will be taken 3, 5, and 8 weeks (+/- 4 days) after the treatment for analysis of
      total and specific IgE levels
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: change of allergen-specific IgE
time frame: 8 weeks
measure: changes in total IgE
time frame: 8 weeks
arm group label: intranasal anti-IgE
arm group type: Experimental
description: Anti-IgE (Xolair) will be freshly diluted in sterile 0.9% sodium chloride solution (438 μg/ml) and will be administered using a metered pump delivering 15 μl per puff to both nostrils on three consecutive days.
arm group label: intranasal allergen
arm group type: Active Comparator
description: GMP produced rBet v 1 will be freshly diluted in sterile 0.9% sodium chloride solution (50 μg/ml) and will be administered using a metered pump delivering 15 μl per puff to both nostrils on three consecutive days.
arm group label: intranasal saline
arm group type: Placebo Comparator
description: Sterile 0.9% sodium chloride solution will be administered using a metered pump delivering 15 μl per puff to both nostrils on three consecutive days.
intervention type: Drug
intervention name: anti-IgE
description: intranasal anti-IgE
arm group label: intranasal anti-IgE
other name: Omalizumab
intervention type: Other
intervention name: intranasal allergen
description: intranasal allergen
arm group label: intranasal allergen
other name: GMP produced recombinant Bet v 1
intervention type: Other
intervention name: intranasal saline
description: intranasal placebo
arm group label: intranasal saline
other name: sodium chloride 0.9%
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Verena Niederberger, MD
role: Principal Investigator
affiliation: Medical University of Vienna
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Verena Niederberger-Leppin
investigator title: ao. Univ.-Prof. Dr.
mesh term: Omalizumab
sharing ipd: Undecided