<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/NCT04489121</url>
  </required_header>
  <id_info>
    <org_study_id>Preseasonal-OMA-AR</org_study_id>
    <nct_id>NCT04489121</nct_id>
  </id_info>
  <brief_title>The Efficacy of Preseasonal Omalizumab Treatment</brief_title>
  <official_title>The Efficacy of Preseasonal Omalizumab Treatment in Seasonal Allergic Rhinitis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Tongren Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Tongren Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Allergic rhinitis (AR) is induced by an immunoglobulin E (IgE)-mediated reaction in the&#xD;
      allergen-sensitized subjects, affecting 10% to 40% of the world population. AR could be&#xD;
      divided into two kinds, perennial AR and seasonal AR (SAR).&#xD;
&#xD;
      In recent years, biologics have become promising drugs for allergic diseases. The efficacy&#xD;
      and safety of Omalizumab in treating SAR have been well proven by previous studies. However,&#xD;
      the efficacy in preseasonal treatment for SAR has not yet been studied before.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 28, 2020</start_date>
  <completion_date type="Actual">October 1, 2020</completion_date>
  <primary_completion_date type="Actual">September 26, 2020</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the change of total nasal symptoms scores</measure>
    <time_frame>at baseline, week 2 (the initial phase of pollen season) , week 4(during the anticipated peak pollen phase), and week 6 (the end of season).</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Rescue medication score</measure>
    <time_frame>at week 2 (the initial phase of pollen season) , week 4(during the anticipated peak pollen phase), and week 6 (the end of season).</time_frame>
    <description>when the symptoms were very severe and could not tolerated, the patients could use loratadine as rescue medication.&#xD;
The need for rescue medication was assessed as rescue medication score (RMS), analyzed as the weekly sum of daily use of Loratadine (10mg/d, equivalent to 1 point) or nasal corticosteroid spray (2 points)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the change of quality of life</measure>
    <time_frame>at baseline, week 2 (the initial phase of pollen season) , week 4(during the anticipated peak pollen phase), and week 6 (the end of season).</time_frame>
    <description>mini Rhinoconjunctivitis Quality of Life Questionnaire (miniRQLQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse events</measure>
    <time_frame>one hour after injection in the Omalizumab group</time_frame>
    <description>Any adverse event following injection was assessed by physicians and patients. Patients in the Omalizumab group are instructed to record any unexpected signs, symptoms, and feelings during the subcutaneous injection of Omalizumab.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>eosinophilic indicators in nasal secretions</measure>
    <time_frame>at baseline, week 2 (the initial phase of pollen season) , week 4(during the anticipated peak pollen phase), and week 6 (the end of season).</time_frame>
    <description>The level of eosinophilic indicators; Charcot-Leyden crystal (CLC) , Cystatin SN</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Seasonal Allergic Rhinitis</condition>
  <arm_group>
    <arm_group_label>omalizumab preseasonal treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For patients in the Omalizumab group, subcutaneous injections of Omalizumab based on the specific participant's weight and serum total IgE was performed 2 weeks prior the anticipated pollen season. Rescue medication could be used during pollen seasons.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No preseasonal treatment was performed. Rescue medication could be used during pollen seasons.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Omalizumab</intervention_name>
    <description>For patients in the Omalizumab group, subcutaneous injections of Omalizumab based on the specific participant's weight and serum total IgE was performed 2 weeks prior the anticipated pollen season.</description>
    <arm_group_label>omalizumab preseasonal treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female outpatients aged 18 to 60 years (inclusive).&#xD;
&#xD;
          -  With history of SAR for at least two years, with/without conjunctivitis and without&#xD;
             asthma&#xD;
&#xD;
          -  Two or more nasal symptoms scores were ≥ 2 points during July - October in the last&#xD;
             year.&#xD;
&#xD;
          -  Sensitised to common autumn pollens including sagewort and ragweed (a specific IgE&#xD;
             level ≥ 3.5 kU/L).&#xD;
&#xD;
          -  Patients who have been informed of the nature and aims of the study and have given&#xD;
             their written consent, willing to comply with the protocol.&#xD;
&#xD;
          -  Patients who are able to understand the information given and the consent and complete&#xD;
             the daily record card.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with oral diseases/ allergies within the run-in period.&#xD;
&#xD;
          -  Patients accepted any kind of operations within 4 weeks of the run-in period.&#xD;
&#xD;
          -  Patients applied for systemic glucocorticoids within 4 weeks in the run-in period.&#xD;
&#xD;
          -  Patients with PAR.&#xD;
&#xD;
          -  Patients with any nasal condition that could confound the results of the study&#xD;
             (chronic rhinitis, chronic rhinosinusitis with/without polyps).&#xD;
&#xD;
          -  Whatever the co-sensitization leading to clinically relevant AR, conjunctivitis or&#xD;
             asthma likely to significantly change the symptoms of the patient throughout the&#xD;
             study.&#xD;
&#xD;
          -  patients with comorbidity of severe asthma.&#xD;
&#xD;
          -  Patients applying beta-antagonist (local or systemic appliance).&#xD;
&#xD;
          -  Pregnant, breast-feeding / sexually active women of childbearing potential.&#xD;
&#xD;
          -  Patients treated with AIT for pollens within 3 years.&#xD;
&#xD;
          -  Participation in any clinical study within the 3 months of the run-in period.&#xD;
&#xD;
          -  Patients at risk of non-compliance..&#xD;
&#xD;
          -  Patients with immunologic suppression, diabetes mellitus, autonomic neuropathy,&#xD;
             coronary heart disease or hypertension.&#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>Luo Zhang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Tongren Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Tongren Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>January 26, 2021</last_update_submitted>
  <last_update_submitted_qc>January 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Tongren Hospital</investigator_affiliation>
    <investigator_full_name>Luo Zhang</investigator_full_name>
    <investigator_title>President, Beijing TongRen Hospital</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rhinitis</mesh_term>
    <mesh_term>Rhinitis, Allergic</mesh_term>
    <mesh_term>Rhinitis, Allergic, Seasonal</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Omalizumab</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04489121
org study id: Preseasonal-OMA-AR
nct id: NCT04489121
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Allergic rhinitis (AR) is induced by an immunoglobulin E (IgE)-mediated reaction in the
      allergen-sensitized subjects, affecting 10% to 40% of the world population. AR could be
      divided into two kinds, perennial AR and seasonal AR (SAR).

      In recent years, biologics have become promising drugs for allergic diseases. The efficacy
      and safety of Omalizumab in treating SAR have been well proven by previous studies. However,
      the efficacy in preseasonal treatment for SAR has not yet been studied before.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: the change of total nasal symptoms scores
time frame: at baseline, week 2 (the initial phase of pollen season) , week 4(during the anticipated peak pollen phase), and week 6 (the end of season).
measure: Rescue medication score
time frame: at week 2 (the initial phase of pollen season) , week 4(during the anticipated peak pollen phase), and week 6 (the end of season).
description: when the symptoms were very severe and could not tolerated, the patients could use loratadine as rescue medication.
The need for rescue medication was assessed as rescue medication score (RMS), analyzed as the weekly sum of daily use of Loratadine (10mg/d, equivalent to 1 point) or nasal corticosteroid spray (2 points)
measure: the change of quality of life
time frame: at baseline, week 2 (the initial phase of pollen season) , week 4(during the anticipated peak pollen phase), and week 6 (the end of season).
description: mini Rhinoconjunctivitis Quality of Life Questionnaire (miniRQLQ)
measure: adverse events
time frame: one hour after injection in the Omalizumab group
description: Any adverse event following injection was assessed by physicians and patients. Patients in the Omalizumab group are instructed to record any unexpected signs, symptoms, and feelings during the subcutaneous injection of Omalizumab.
measure: eosinophilic indicators in nasal secretions
time frame: at baseline, week 2 (the initial phase of pollen season) , week 4(during the anticipated peak pollen phase), and week 6 (the end of season).
description: The level of eosinophilic indicators; Charcot-Leyden crystal (CLC) , Cystatin SN
arm group label: omalizumab preseasonal treatment
arm group type: Experimental
description: For patients in the Omalizumab group, subcutaneous injections of Omalizumab based on the specific participant's weight and serum total IgE was performed 2 weeks prior the anticipated pollen season. Rescue medication could be used during pollen seasons.
arm group label: control
arm group type: No Intervention
description: No preseasonal treatment was performed. Rescue medication could be used during pollen seasons.
intervention type: Drug
intervention name: Omalizumab
description: For patients in the Omalizumab group, subcutaneous injections of Omalizumab based on the specific participant's weight and serum total IgE was performed 2 weeks prior the anticipated pollen season.
arm group label: omalizumab preseasonal treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Luo Zhang
role: Principal Investigator
affiliation: Beijing Tongren Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Tongren Hospital
investigator full name: Luo Zhang
investigator title: President, Beijing TongRen Hospital
mesh term: Rhinitis
mesh term: Rhinitis, Allergic
mesh term: Rhinitis, Allergic, Seasonal
mesh term: Omalizumab