<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/NCT03290248</url>
  </required_header>
  <id_info>
    <org_study_id>ARB244-001</org_study_id>
    <nct_id>NCT03290248</nct_id>
  </id_info>
  <brief_title>Study to Assess the Safety, Tolerability, and Preliminary Efficacy of B244 in Healthy Volunteers and Subjects With Seasonal Allergic Rhinitis</brief_title>
  <official_title>A Prospective, Controlled, Double Blind, Multi-Center, Randomized, 3 Arm, Phase 1b/2a Study to Assess the Safety, Tolerability, and Preliminary Efficacy of B244 Delivered as an Intranasal Spray in Healthy Volunteers and Subjects With Seasonal Allergic Rhinitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AOBiome LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Orange County Research Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Integrium</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>AOBiome LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Prospective, Controlled, Double Blinded, Single Center, Randomized, 3 Arm, Parallel&#xD;
      Assignment, Phase 1b/2a Study to assess the safety, tolerability, and preliminary efficacy of&#xD;
      B244 delivered as an intranasal spray in healthy volunteers and subjects with seasonal&#xD;
      allergic rhinitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Prospective, Controlled, Double Blinded, Single Center, Randomized, 3 Arm, Parallel&#xD;
      Assignment, Phase 1b/2a Study to assess the safety, tolerability, and preliminary efficacy of&#xD;
      B244 delivered as an intranasal spray in healthy volunteers and subjects with seasonal&#xD;
      allergic rhinitis. This will be a 2-part study. In Part 1, safety and tolerability will be&#xD;
      evaluated during 14 days of study treatment twice-a-day followed by 4 weeks of follow-up in&#xD;
      healthy volunteers. In Part 2, preliminary efficacy will be evaluated in subjects with a&#xD;
      history of seasonal allergic rhinitis outside of the local pollen season.&#xD;
&#xD;
      For Part 1 (safety and tolerability evaluation in healthy volunteers) we will enroll 24&#xD;
      subjects. Safety and tolerability will be assessed by reporting of AEs, physical examination&#xD;
      and vital signs (blood pressure, heart rate, respiratory rate) during 14 days of treatment&#xD;
      and up to 28 days of follow-up.&#xD;
&#xD;
      An internal safety committee meeting will review the 2 week Part 1 safety data and, if there&#xD;
      are no safety concerns, the study will proceed to Part 2 to evaluate preliminary efficacy in&#xD;
      subjects with a history of seasonal allergic rhinitis (SAR)&#xD;
&#xD;
      For Part 2 (preliminary efficacy evaluation in subjects with a history of SAR to ragweed&#xD;
      pollen) will enroll 42 subjects. Safety and tolerability will be assessed in subjects with&#xD;
      allergic rhinitis by reporting of AEs, physical examination and vital signs (blood pressure,&#xD;
      heart rate, respiratory rate) during 14 days of treatment.&#xD;
&#xD;
      For Part 2, study will be paused for safety review using the same stopping criteria as in&#xD;
      Part 1.&#xD;
&#xD;
      Rescue medications will not be allowed during the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 19, 2017</start_date>
  <completion_date type="Actual">December 21, 2018</completion_date>
  <primary_completion_date type="Actual">December 21, 2018</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Randomization will be 1:1:1 so that equal number of subjects will be treated in each arm of the study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>This is a double blind study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0</measure>
    <time_frame>Baseline to Day 28</time_frame>
    <description>Safety and tolerability endpoints will consist of all treatment-related adverse events reporting during the study duration for subjects only from Part 1 of the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Total Nasal Symptom Score (TNSS) After Prophylaxis Treatment</measure>
    <time_frame>Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.</time_frame>
    <description>Total Nasal Symptom Score (TNSS) is the sum of sub-scores for each of nasal congestion, sneezing, nasal itching, and rhinorrhea at each time point, using a four point scale (0-3; 0 = none; 1 = mild; 2 = moderate; 3 = severe), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. TNSS is calculated by adding the sub-score for each of the symptoms to a total out of 12. For TNSS and Area Under the Curve (AUC) analyses, an Analysis of Covariance with treatment and site as factors and Visit 3 (or Visit 2) value as a covariate was used to test for treatment effect at Visit 4.&#xD;
Observed AUC (0-2 Hours) was defined as TNSS from 0 to 120 minutes post Nasal Allergen Challenge (NAC). The Pre-NAC Adjusted AUC (0-2 Hours) was defined as the observed value minus the 0 minutes prior NAC value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Nasal Symptom Scores of Nasal Congestion After Prophylaxis Treatment</measure>
    <time_frame>Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.</time_frame>
    <description>All measurements were taken 120 minutes Post-Nasal Allergen Challenge (Post-NAC) at Visit 4 and compared to Baseline Visit 3. Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline. Nasal congestion was categorized as None, Mild, Moderate, or Severe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Nasal Symptom Scores of Rhinorrhea After Prophylaxis Treatment</measure>
    <time_frame>Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.</time_frame>
    <description>All measurements were taken 120 minutes Post-Nasal Allergen Challenge (Post-NAC) at Visit 4 and compared to Baseline Visit 3. Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline. Rhinorrhea was categorized as None, Mild, Moderate, or Severe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Nasal Symptom Scores of Nasal Itching After Prophylaxis Treatment</measure>
    <time_frame>Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.</time_frame>
    <description>All measurements were taken 120 minutes Post-Nasal Allergen Challenge (Post-NAC) at Visit 4 and compared to Baseline Visit 3. Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline. Nasal itching was categorized as None, Mild, Moderate, or Severe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Nasal Symptom Scores of Sneezing After Prophylaxis Treatment</measure>
    <time_frame>Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.</time_frame>
    <description>All measurements were taken 120 minutes Post-Nasal Allergen Challenge (Post-NAC) at Visit 4 and compared to Baseline Visit 3. Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline. Sneezing was categorized as None, Mild, Moderate, or Severe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nasal Symptom-free Response Rate in Nasal Congestion Scores After Prophylaxis Treatment</measure>
    <time_frame>Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.</time_frame>
    <description>Nasal symptom free response rate was assessed 120 minutes Post-Nasal Allergen Challenge (Post-NAC) to be scored as Yes or No to nasal congestion at Visit 4 (yes indicates subject is free from nasal congestion symptom and no indicates subject still has nasal itching symptom). Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nasal Symptom-free Response Rate in Rhinorrhea Scores After Prophylaxis Treatment</measure>
    <time_frame>Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.</time_frame>
    <description>Nasal symptom free response rate was assessed 120 minutes Post-Nasal Allergen Challenge (Post-NAC) to be scored as Yes or No to rhinorrhea at Visit 4 (yes indicates subject is free from rhinorrhea symptom and no indicates subject still has nasal itching symptom). Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nasal Symptom-free Response Rate in Nasal Itching Scores After Prophylaxis Treatment</measure>
    <time_frame>Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.</time_frame>
    <description>Nasal symptom free response rate was assessed 120 minutes Post-Nasal Allergen Challenge (Post-NAC) to be scored as Yes or No to nasal itching at Visit 4 (yes indicates subject is free from nasal itching symptom and no indicates subject still has nasal itching symptom). Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nasal Symptom-free Response Rate in Sneezing Scores After Prophylaxis Treatment</measure>
    <time_frame>Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.</time_frame>
    <description>Nasal symptom free response rate was assessed 120 minutes Post-Nasal Allergen Challenge (Post-NAC) to be scored as Yes or No to sneezing at Visit 4 (yes indicates subject is free from sneezing symptom and no indicates subject still has nasal itching symptom). Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nasal Symptom-free Response Rate in TNSS After Prophylaxis Treatment</measure>
    <time_frame>Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.</time_frame>
    <description>Number of subjects that had 25% and 50% reduction in Observed Area Under the Curve (AUC) (0-120 minutes)/Pre-NAC Adjusted AUC (0-120 minutes) at Visit 4 (Day 28) from Visit 2 Observed AUC (0-120 minutes)/Pre-NAC Adjusted AUC (0-120 minutes). For TNSS and Area Under the Curve (AUC) analyses, an Analysis of Covariance with treatment and site as factors and Visit 3 (or Visit 2) value as a covariate was used to test for treatment effect at Visit 4. Observed AUC (0-2 Hours) was defined as TNSS from 0 to 120 minutes post Nasal Allergen Challenge (NAC). The Pre-NAC Adjusted AUC (0-2 Hours) was defined as the observed value minus the 0 minutes prior NAC value.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Peak Nasal Inspiratory Flow (PNIF)</measure>
    <time_frame>Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.</time_frame>
    <description>Peak Nasal Inspiratory Flow (PNIF) is a commonly used method for assessing nasal patency and provides an objective measurement of nasal airflow obstruction. The outcome is a direct representation of nasal congestion. Change in PNIF Observed Inverted Area Under the Curve (AUC) was measured between baseline and Visit 4. A decrease in PNIF Observed Inverted AUC(0-2 Hours) was considered an improvement in nasal airflow obstruction. Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Nasal Inflammation Score Using Otoscope</measure>
    <time_frame>Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.</time_frame>
    <description>Nasal inflammation were graded by a clinician using a 0-3 nasal inflammation scale based on otoscope measurement where 0 = none, 1 = mild, 2 = moderate, and 3 = severe inflammation 120 minutes Post Nasal Allergen Challenge (Post-NAC).</description>
  </other_outcome>
  <other_outcome>
    <measure>Intranasal Nitric Oxide Levels</measure>
    <time_frame>Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.</time_frame>
    <description>Exhaled nasal nitric oxide (NO) was measured from the nasal cavity by a NO analyzer 120 minutes Post Nasal Allergen Challenge (Post-NAC).</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Cytokine Concentration in Nasal Cavity and Blood</measure>
    <time_frame>Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.</time_frame>
    <description>To evaluate if B244 administration will affect the levels of cytokine biomarkers in nasal cavity and blood.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">71</enrollment>
  <condition>Allergic Rhinitis</condition>
  <condition>Allergic Rhinitis Due to Grass Pollen</condition>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Vehicle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B 244 1x (low dose)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B244 4x (mid dose)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>B244 suspension</intervention_name>
    <description>B244 suspension in 30ml/bottle</description>
    <arm_group_label>B 244 1x (low dose)</arm_group_label>
    <arm_group_label>B244 4x (mid dose)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Vehicle</intervention_name>
    <description>Vehicle, 30ml/bottle</description>
    <arm_group_label>Vehicle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and Females, 18 to 65 years of age (committed to consistent use of an acceptable&#xD;
             method of birth control as described in Section 10).&#xD;
&#xD;
          -  In good general health as determined by a thorough medical history and physical&#xD;
             examination, and vital signs.&#xD;
&#xD;
          -  Nonsmoker or ex-smoker (stopped &gt;1 year prior to study entry).&#xD;
&#xD;
          -  Subjects willing and able to provide written informed consent.&#xD;
&#xD;
          -  Is willing and able to comply with the requirements of the protocol and must be&#xD;
             available for the full duration of the study.&#xD;
&#xD;
          -  For Part 1, subjects asymptomatic from any seasonal or perennial allergens.&#xD;
&#xD;
          -  For Part 1, elevated systolic blood pressure greater than 120 but less than 160 and&#xD;
             never been on antihypertensive medications or have been off any hypertensive treatment&#xD;
             for a period of 12 weeks or longer.&#xD;
&#xD;
          -  For Part 2, subjects with a well-documented history of seasonal allergic rhinitis&#xD;
             (specifically ragweed pollen) with documentation of sensitivity by positive skin&#xD;
             testing and/or IgE testing to the relevant allergens 12 months prior to enrollment&#xD;
             that correlate with clinical history.&#xD;
&#xD;
          -  For Part 2, a ragweed positive skin prick test with a wheal diameter at least 5 mm&#xD;
             larger than the negative control and/or a ragweed specific IgE greater or equal to 0.7&#xD;
             kU/L.&#xD;
&#xD;
          -  For Part 2, subjects with confounding allergies, or sensitization to cat epithelia,&#xD;
             dog epithelia, Dermatophagoides farinae, or Dermatophagoides pteronyssinus or&#xD;
             prevalent and relevant seasonal allergens as per the skin prick test may be included&#xD;
             if sensitization is not clinically relevant (ie. subject is non-symptomatic and/or can&#xD;
             avoid the allergen during the study) at the discretion of the Investigator.&#xD;
&#xD;
          -  For Part 2, subjects with a baseline TNSS ≤ 3/12 at Visit 3 and a minimum qualifying&#xD;
             TNSS score of a change of 6/12 from their baseline score after NAC #1 on at least 2&#xD;
             diary cards.&#xD;
&#xD;
          -  For Part 2, subjects' average post diluents nasal congestion score must be &lt; 1 at&#xD;
             admission for each study visit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or breast-feeding&#xD;
&#xD;
          -  Female of childbearing potential not using adequate contraceptive measures.&#xD;
&#xD;
          -  Smoking within the past year or during the protocol.&#xD;
&#xD;
          -  Systemic corticosteroid or other immunosuppressive medications use in the previous&#xD;
             three months or during the protocol.*&#xD;
&#xD;
          -  Intranasal corticosteroid use in the previous month or during the protocol.*&#xD;
&#xD;
          -  Intranasal antihistamine or cromolyn use in the previous week or during the study.*&#xD;
&#xD;
          -  Allergen immunotherapy during previous 12 months or during the protocol.*&#xD;
&#xD;
          -  Omalizumab use in previous 12 months or during the protocol.*&#xD;
&#xD;
          -  Systemic antihistamine or leukotriene modifying medication use in the previous week or&#xD;
             during the protocol.*&#xD;
&#xD;
          -  Use of antibiotics, NSAIDS, antihypertensives, beta-blockers, photosensitizing&#xD;
             medications, or vitamin D supplements during study.&#xD;
&#xD;
          -  Use of any intranasally administered over-the-counter product or nasal irrigation&#xD;
             (e.g., neti pot) during study.&#xD;
&#xD;
          -  Inability to give informed consent.&#xD;
&#xD;
          -  Persistent asthma or any medical condition that in the opinion of the investigator may&#xD;
             compromise the subject's ability to safely participate in the study.&#xD;
&#xD;
          -  Subjects with any significant clinical abnormalities which may interfere with study&#xD;
             participation.&#xD;
&#xD;
          -  Prior use of AO+ Mist.&#xD;
&#xD;
          -  Subjects with immunodeficiencies, nasal lesions, nasal polyps, or sinus infections.&#xD;
&#xD;
          -  Use of an investigational drug within 30 days before screening Visit 1. * Exclusionary&#xD;
             criterion due to 1) medication use as marker of persistent comorbid allergic or&#xD;
             inflammatory condition that may increase subject risk with study participation, 2)&#xD;
             potential of medication to interfere with study outcome measures or results.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joel Neutel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Study PI</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Orange County Research Center</name>
      <address>
        <city>Tustin</city>
        <state>California</state>
        <zip>92780</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inflamax</name>
      <address>
        <city>Mississauga</city>
        <state>Ontario</state>
        <zip>M6G 3V1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <results_first_submitted>July 19, 2022</results_first_submitted>
  <results_first_submitted_qc>October 31, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">November 25, 2022</results_first_posted>
  <disposition_first_submitted>July 28, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>October 31, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">November 25, 2022</disposition_first_posted>
  <last_update_submitted>October 31, 2022</last_update_submitted>
  <last_update_submitted_qc>October 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 29, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/48/NCT03290248/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 3, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/48/NCT03290248/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Vehicle</title>
          <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
Vehicle: Vehicle, 30ml/bottle</description>
        </group>
        <group group_id="P2">
          <title>B 244 1x (Low Dose)</title>
          <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle</description>
        </group>
        <group group_id="P3">
          <title>B244 4x (Mid Dose)</title>
          <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Study Part 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Study Part 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Population includes patients from Part 1 (n=24) Part 2 (n=47) of the study.</population>
      <group_list>
        <group group_id="B1">
          <title>Vehicle</title>
          <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
Vehicle: Vehicle, 30ml/bottle</description>
        </group>
        <group group_id="B2">
          <title>B 244 1x (Low Dose)</title>
          <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle</description>
        </group>
        <group group_id="B3">
          <title>B244 4x (Mid Dose)</title>
          <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="23"/>
            <count group_id="B2" value="24"/>
            <count group_id="B3" value="24"/>
            <count group_id="B4" value="71"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Part 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="8"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="8"/>
                    <count group_id="B4" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47.29" spread="11.179"/>
                    <measurement group_id="B2" value="44.60" spread="11.193"/>
                    <measurement group_id="B3" value="45.36" spread="10.316"/>
                    <measurement group_id="B4" value="45.76" spread="10.477"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="15"/>
                    <count group_id="B2" value="16"/>
                    <count group_id="B3" value="16"/>
                    <count group_id="B4" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47.20" spread="9.470"/>
                    <measurement group_id="B2" value="45.49" spread="12.145"/>
                    <measurement group_id="B3" value="42.30" spread="12.754"/>
                    <measurement group_id="B4" value="44.95" spread="11.516"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Part 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="8"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="8"/>
                    <count group_id="B4" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="15"/>
                    <count group_id="B2" value="16"/>
                    <count group_id="B3" value="16"/>
                    <count group_id="B4" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <population>Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Part 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="8"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="8"/>
                    <count group_id="B4" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="15"/>
                    <count group_id="B2" value="16"/>
                    <count group_id="B3" value="16"/>
                    <count group_id="B4" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <population>Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Part 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="8"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="8"/>
                    <count group_id="B4" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="15"/>
                    <count group_id="B2" value="16"/>
                    <count group_id="B3" value="16"/>
                    <count group_id="B4" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Tobacco History</title>
          <population>Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Part 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="8"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="8"/>
                    <count group_id="B4" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Never</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Current</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Former</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="15"/>
                    <count group_id="B2" value="16"/>
                    <count group_id="B3" value="16"/>
                    <count group_id="B4" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Never</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Current</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Former</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Screening Height</title>
          <population>Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Part 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="8"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="8"/>
                    <count group_id="B4" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="174.0" spread="8.20"/>
                    <measurement group_id="B2" value="169.8" spread="8.40"/>
                    <measurement group_id="B3" value="172.8" spread="11.60"/>
                    <measurement group_id="B4" value="172.2" spread="9.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="15"/>
                    <count group_id="B2" value="16"/>
                    <count group_id="B3" value="16"/>
                    <count group_id="B4" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="169.0" spread="3.73"/>
                    <measurement group_id="B2" value="165.9" spread="8.38"/>
                    <measurement group_id="B3" value="167.1" spread="9.88"/>
                    <measurement group_id="B4" value="167.3" spread="8.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Screening Weight</title>
          <population>Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.</population>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Part 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="8"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="8"/>
                    <count group_id="B4" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="81.83" spread="22.316"/>
                    <measurement group_id="B2" value="77.94" spread="10.679"/>
                    <measurement group_id="B3" value="89.55" spread="21.376"/>
                    <measurement group_id="B4" value="83.10" spread="18.699"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="15"/>
                    <count group_id="B2" value="16"/>
                    <count group_id="B3" value="16"/>
                    <count group_id="B4" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="76.89" spread="15.279"/>
                    <measurement group_id="B2" value="79.69" spread="14.577"/>
                    <measurement group_id="B3" value="79.72" spread="17.633"/>
                    <measurement group_id="B4" value="78.81" spread="15.604"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Screening BMI</title>
          <population>Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.</population>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Part 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="8"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="8"/>
                    <count group_id="B4" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.77" spread="5.890"/>
                    <measurement group_id="B2" value="27.15" spread="4.197"/>
                    <measurement group_id="B3" value="29.76" spread="5.013"/>
                    <measurement group_id="B4" value="27.89" spread="5.046"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="15"/>
                    <count group_id="B2" value="16"/>
                    <count group_id="B3" value="16"/>
                    <count group_id="B4" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.86" spread="4.803"/>
                    <measurement group_id="B2" value="28.93" spread="4.868"/>
                    <measurement group_id="B3" value="28.59" spread="6.053"/>
                    <measurement group_id="B4" value="28.15" spread="5.250"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0</title>
        <description>Safety and tolerability endpoints will consist of all treatment-related adverse events reporting during the study duration for subjects only from Part 1 of the study.</description>
        <time_frame>Baseline to Day 28</time_frame>
        <population>Population included subjects from Part 1 of the study and those who had received at least one dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Vehicle</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
Vehicle: Vehicle, 30ml/bottle</description>
          </group>
          <group group_id="O2">
            <title>B 244 1x (Low Dose)</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle</description>
          </group>
          <group group_id="O3">
            <title>B244 4x (Mid Dose)</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0</title>
          <description>Safety and tolerability endpoints will consist of all treatment-related adverse events reporting during the study duration for subjects only from Part 1 of the study.</description>
          <population>Population included subjects from Part 1 of the study and those who had received at least one dose of study medication.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Drug Related TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug Related Severe TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug Related Serious TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Total Nasal Symptom Score (TNSS) After Prophylaxis Treatment</title>
        <description>Total Nasal Symptom Score (TNSS) is the sum of sub-scores for each of nasal congestion, sneezing, nasal itching, and rhinorrhea at each time point, using a four point scale (0-3; 0 = none; 1 = mild; 2 = moderate; 3 = severe), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. TNSS is calculated by adding the sub-score for each of the symptoms to a total out of 12. For TNSS and Area Under the Curve (AUC) analyses, an Analysis of Covariance with treatment and site as factors and Visit 3 (or Visit 2) value as a covariate was used to test for treatment effect at Visit 4.&#xD;
Observed AUC (0-2 Hours) was defined as TNSS from 0 to 120 minutes post Nasal Allergen Challenge (NAC). The Pre-NAC Adjusted AUC (0-2 Hours) was defined as the observed value minus the 0 minutes prior NAC value.</description>
        <time_frame>Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.</time_frame>
        <population>Population includes only patients from Part 2 of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Vehicle</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
Vehicle: Vehicle, 30ml/bottle</description>
          </group>
          <group group_id="O2">
            <title>B 244 1x (Low Dose)</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle</description>
          </group>
          <group group_id="O3">
            <title>B244 4x (Mid Dose)</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Total Nasal Symptom Score (TNSS) After Prophylaxis Treatment</title>
          <description>Total Nasal Symptom Score (TNSS) is the sum of sub-scores for each of nasal congestion, sneezing, nasal itching, and rhinorrhea at each time point, using a four point scale (0-3; 0 = none; 1 = mild; 2 = moderate; 3 = severe), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. TNSS is calculated by adding the sub-score for each of the symptoms to a total out of 12. For TNSS and Area Under the Curve (AUC) analyses, an Analysis of Covariance with treatment and site as factors and Visit 3 (or Visit 2) value as a covariate was used to test for treatment effect at Visit 4.&#xD;
Observed AUC (0-2 Hours) was defined as TNSS from 0 to 120 minutes post Nasal Allergen Challenge (NAC). The Pre-NAC Adjusted AUC (0-2 Hours) was defined as the observed value minus the 0 minutes prior NAC value.</description>
          <population>Population includes only patients from Part 2 of the study.</population>
          <units>score on a scale*hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Observed AUC (0-2 Hours)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.1" spread="3.53"/>
                    <measurement group_id="O2" value="-2.5" spread="4.51"/>
                    <measurement group_id="O3" value="-4.9" spread="3.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre-NAC Adjusted (0-2 Hours)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.9" spread="3.88"/>
                    <measurement group_id="O2" value="-3.7" spread="6.84"/>
                    <measurement group_id="O3" value="-4.9" spread="3.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subjective Nasal Symptom Scores of Nasal Congestion After Prophylaxis Treatment</title>
        <description>All measurements were taken 120 minutes Post-Nasal Allergen Challenge (Post-NAC) at Visit 4 and compared to Baseline Visit 3. Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline. Nasal congestion was categorized as None, Mild, Moderate, or Severe.</description>
        <time_frame>Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.</time_frame>
        <population>Population includes only patients from Part 2 of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Vehicle</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
Vehicle: Vehicle, 30ml/bottle</description>
          </group>
          <group group_id="O2">
            <title>B 244 1x (Low Dose)</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle</description>
          </group>
          <group group_id="O3">
            <title>B244 4x (Mid Dose)</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Nasal Symptom Scores of Nasal Congestion After Prophylaxis Treatment</title>
          <description>All measurements were taken 120 minutes Post-Nasal Allergen Challenge (Post-NAC) at Visit 4 and compared to Baseline Visit 3. Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline. Nasal congestion was categorized as None, Mild, Moderate, or Severe.</description>
          <population>Population includes only patients from Part 2 of the study.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 2 (Day 0)</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3 (Day 14)</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4 (Day 28)</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subjective Nasal Symptom Scores of Rhinorrhea After Prophylaxis Treatment</title>
        <description>All measurements were taken 120 minutes Post-Nasal Allergen Challenge (Post-NAC) at Visit 4 and compared to Baseline Visit 3. Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline. Rhinorrhea was categorized as None, Mild, Moderate, or Severe.</description>
        <time_frame>Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.</time_frame>
        <population>Population includes only patients from Part 2 of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Vehicle</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
Vehicle: Vehicle, 30ml/bottle</description>
          </group>
          <group group_id="O2">
            <title>B 244 1x (Low Dose)</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle</description>
          </group>
          <group group_id="O3">
            <title>B244 4x (Mid Dose)</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
B244 suspension: B244 suspension (4x10E9 cells/ml)in 30ml/bottle</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Nasal Symptom Scores of Rhinorrhea After Prophylaxis Treatment</title>
          <description>All measurements were taken 120 minutes Post-Nasal Allergen Challenge (Post-NAC) at Visit 4 and compared to Baseline Visit 3. Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline. Rhinorrhea was categorized as None, Mild, Moderate, or Severe.</description>
          <population>Population includes only patients from Part 2 of the study.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 2 (Day 0)</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3 (Day 14)</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4 (Day 28)</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subjective Nasal Symptom Scores of Nasal Itching After Prophylaxis Treatment</title>
        <description>All measurements were taken 120 minutes Post-Nasal Allergen Challenge (Post-NAC) at Visit 4 and compared to Baseline Visit 3. Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline. Nasal itching was categorized as None, Mild, Moderate, or Severe.</description>
        <time_frame>Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.</time_frame>
        <population>Population includes only patients from Part 2 of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Vehicle</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
Vehicle: Vehicle, 30ml/bottle</description>
          </group>
          <group group_id="O2">
            <title>B 244 1x (Low Dose)</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle</description>
          </group>
          <group group_id="O3">
            <title>B244 4x (Mid Dose)</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Nasal Symptom Scores of Nasal Itching After Prophylaxis Treatment</title>
          <description>All measurements were taken 120 minutes Post-Nasal Allergen Challenge (Post-NAC) at Visit 4 and compared to Baseline Visit 3. Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline. Nasal itching was categorized as None, Mild, Moderate, or Severe.</description>
          <population>Population includes only patients from Part 2 of the study.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 2 (Day 0)</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3 (Day 14)</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4 (Day 28)</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subjective Nasal Symptom Scores of Sneezing After Prophylaxis Treatment</title>
        <description>All measurements were taken 120 minutes Post-Nasal Allergen Challenge (Post-NAC) at Visit 4 and compared to Baseline Visit 3. Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline. Sneezing was categorized as None, Mild, Moderate, or Severe.</description>
        <time_frame>Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.</time_frame>
        <population>Population includes only patients from Part 2 of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Vehicle</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
Vehicle: Vehicle, 30ml/bottle</description>
          </group>
          <group group_id="O2">
            <title>B 244 1x (Low Dose)</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle</description>
          </group>
          <group group_id="O3">
            <title>B244 4x (Mid Dose)</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Nasal Symptom Scores of Sneezing After Prophylaxis Treatment</title>
          <description>All measurements were taken 120 minutes Post-Nasal Allergen Challenge (Post-NAC) at Visit 4 and compared to Baseline Visit 3. Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline. Sneezing was categorized as None, Mild, Moderate, or Severe.</description>
          <population>Population includes only patients from Part 2 of the study.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 2 (Day 0)</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3 (Day 14)</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4 (Day 28)</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Nasal Symptom-free Response Rate in Nasal Congestion Scores After Prophylaxis Treatment</title>
        <description>Nasal symptom free response rate was assessed 120 minutes Post-Nasal Allergen Challenge (Post-NAC) to be scored as Yes or No to nasal congestion at Visit 4 (yes indicates subject is free from nasal congestion symptom and no indicates subject still has nasal itching symptom). Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline.</description>
        <time_frame>Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.</time_frame>
        <population>Population includes only patients from Part 2 of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Vehicle</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
Vehicle: Vehicle, 30ml/bottle</description>
          </group>
          <group group_id="O2">
            <title>B 244 1x (Low Dose)</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle</description>
          </group>
          <group group_id="O3">
            <title>B244 4x (Mid Dose)</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle</description>
          </group>
        </group_list>
        <measure>
          <title>Nasal Symptom-free Response Rate in Nasal Congestion Scores After Prophylaxis Treatment</title>
          <description>Nasal symptom free response rate was assessed 120 minutes Post-Nasal Allergen Challenge (Post-NAC) to be scored as Yes or No to nasal congestion at Visit 4 (yes indicates subject is free from nasal congestion symptom and no indicates subject still has nasal itching symptom). Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline.</description>
          <population>Population includes only patients from Part 2 of the study.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Nasal Symptom-free Response Rate in Rhinorrhea Scores After Prophylaxis Treatment</title>
        <description>Nasal symptom free response rate was assessed 120 minutes Post-Nasal Allergen Challenge (Post-NAC) to be scored as Yes or No to rhinorrhea at Visit 4 (yes indicates subject is free from rhinorrhea symptom and no indicates subject still has nasal itching symptom). Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline.</description>
        <time_frame>Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.</time_frame>
        <population>Population includes only patients from Part 2 of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Vehicle</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
Vehicle: Vehicle, 30ml/bottle</description>
          </group>
          <group group_id="O2">
            <title>B 244 1x (Low Dose)</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle</description>
          </group>
          <group group_id="O3">
            <title>B244 4x (Mid Dose)</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle</description>
          </group>
        </group_list>
        <measure>
          <title>Nasal Symptom-free Response Rate in Rhinorrhea Scores After Prophylaxis Treatment</title>
          <description>Nasal symptom free response rate was assessed 120 minutes Post-Nasal Allergen Challenge (Post-NAC) to be scored as Yes or No to rhinorrhea at Visit 4 (yes indicates subject is free from rhinorrhea symptom and no indicates subject still has nasal itching symptom). Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline.</description>
          <population>Population includes only patients from Part 2 of the study.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Nasal Symptom-free Response Rate in Nasal Itching Scores After Prophylaxis Treatment</title>
        <description>Nasal symptom free response rate was assessed 120 minutes Post-Nasal Allergen Challenge (Post-NAC) to be scored as Yes or No to nasal itching at Visit 4 (yes indicates subject is free from nasal itching symptom and no indicates subject still has nasal itching symptom). Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline.</description>
        <time_frame>Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.</time_frame>
        <population>Population includes only patients from Part 2 of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Vehicle</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
Vehicle: Vehicle, 30ml/bottle</description>
          </group>
          <group group_id="O2">
            <title>B 244 1x (Low Dose)</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle</description>
          </group>
          <group group_id="O3">
            <title>B244 4x (Mid Dose)</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle</description>
          </group>
        </group_list>
        <measure>
          <title>Nasal Symptom-free Response Rate in Nasal Itching Scores After Prophylaxis Treatment</title>
          <description>Nasal symptom free response rate was assessed 120 minutes Post-Nasal Allergen Challenge (Post-NAC) to be scored as Yes or No to nasal itching at Visit 4 (yes indicates subject is free from nasal itching symptom and no indicates subject still has nasal itching symptom). Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline.</description>
          <population>Population includes only patients from Part 2 of the study.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Nasal Symptom-free Response Rate in Sneezing Scores After Prophylaxis Treatment</title>
        <description>Nasal symptom free response rate was assessed 120 minutes Post-Nasal Allergen Challenge (Post-NAC) to be scored as Yes or No to sneezing at Visit 4 (yes indicates subject is free from sneezing symptom and no indicates subject still has nasal itching symptom). Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline.</description>
        <time_frame>Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.</time_frame>
        <population>Population includes only patients from Part 2 of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Vehicle</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
Vehicle: Vehicle, 30ml/bottle</description>
          </group>
          <group group_id="O2">
            <title>B 244 1x (Low Dose)</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle</description>
          </group>
          <group group_id="O3">
            <title>B244 4x (Mid Dose)</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle</description>
          </group>
        </group_list>
        <measure>
          <title>Nasal Symptom-free Response Rate in Sneezing Scores After Prophylaxis Treatment</title>
          <description>Nasal symptom free response rate was assessed 120 minutes Post-Nasal Allergen Challenge (Post-NAC) to be scored as Yes or No to sneezing at Visit 4 (yes indicates subject is free from sneezing symptom and no indicates subject still has nasal itching symptom). Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline.</description>
          <population>Population includes only patients from Part 2 of the study.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Nasal Symptom-free Response Rate in TNSS After Prophylaxis Treatment</title>
        <description>Number of subjects that had 25% and 50% reduction in Observed Area Under the Curve (AUC) (0-120 minutes)/Pre-NAC Adjusted AUC (0-120 minutes) at Visit 4 (Day 28) from Visit 2 Observed AUC (0-120 minutes)/Pre-NAC Adjusted AUC (0-120 minutes). For TNSS and Area Under the Curve (AUC) analyses, an Analysis of Covariance with treatment and site as factors and Visit 3 (or Visit 2) value as a covariate was used to test for treatment effect at Visit 4. Observed AUC (0-2 Hours) was defined as TNSS from 0 to 120 minutes post Nasal Allergen Challenge (NAC). The Pre-NAC Adjusted AUC (0-2 Hours) was defined as the observed value minus the 0 minutes prior NAC value.</description>
        <time_frame>Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.</time_frame>
        <population>Population includes only patients from Part 2 of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Vehicle</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
Vehicle: Vehicle, 30ml/bottle</description>
          </group>
          <group group_id="O2">
            <title>B 244 1x (Low Dose)</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle</description>
          </group>
          <group group_id="O3">
            <title>B244 4x (Mid Dose)</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle</description>
          </group>
        </group_list>
        <measure>
          <title>Nasal Symptom-free Response Rate in TNSS After Prophylaxis Treatment</title>
          <description>Number of subjects that had 25% and 50% reduction in Observed Area Under the Curve (AUC) (0-120 minutes)/Pre-NAC Adjusted AUC (0-120 minutes) at Visit 4 (Day 28) from Visit 2 Observed AUC (0-120 minutes)/Pre-NAC Adjusted AUC (0-120 minutes). For TNSS and Area Under the Curve (AUC) analyses, an Analysis of Covariance with treatment and site as factors and Visit 3 (or Visit 2) value as a covariate was used to test for treatment effect at Visit 4. Observed AUC (0-2 Hours) was defined as TNSS from 0 to 120 minutes post Nasal Allergen Challenge (NAC). The Pre-NAC Adjusted AUC (0-2 Hours) was defined as the observed value minus the 0 minutes prior NAC value.</description>
          <population>Population includes only patients from Part 2 of the study.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>25% Reduction from Visit 2 Observed AUC (0-120 minutes)</title>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>25% Reduction from Visit 2 Pre-NAC Adjusted AUC (0-120 minutes)</title>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50% Reduction from Visit 2 Observed AUC (0-120 minutes)</title>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50% Reduction from Visit 2 Pre-NAC Adjusted AUC (0-120 minutes)</title>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change in Peak Nasal Inspiratory Flow (PNIF)</title>
        <description>Peak Nasal Inspiratory Flow (PNIF) is a commonly used method for assessing nasal patency and provides an objective measurement of nasal airflow obstruction. The outcome is a direct representation of nasal congestion. Change in PNIF Observed Inverted Area Under the Curve (AUC) was measured between baseline and Visit 4. A decrease in PNIF Observed Inverted AUC(0-2 Hours) was considered an improvement in nasal airflow obstruction. Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline.</description>
        <time_frame>Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.</time_frame>
        <population>Population includes only patients from Part 2 of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Vehicle</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
Vehicle: Vehicle, 30ml/bottle</description>
          </group>
          <group group_id="O2">
            <title>B 244 1x (Low Dose)</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle</description>
          </group>
          <group group_id="O3">
            <title>B244 4x (Mid Dose)</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Peak Nasal Inspiratory Flow (PNIF)</title>
          <description>Peak Nasal Inspiratory Flow (PNIF) is a commonly used method for assessing nasal patency and provides an objective measurement of nasal airflow obstruction. The outcome is a direct representation of nasal congestion. Change in PNIF Observed Inverted Area Under the Curve (AUC) was measured between baseline and Visit 4. A decrease in PNIF Observed Inverted AUC(0-2 Hours) was considered an improvement in nasal airflow obstruction. Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline.</description>
          <population>Population includes only patients from Part 2 of the study.</population>
          <units>L*Hr/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from Visit 3 to Visit 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-60.8" spread="57.83"/>
                    <measurement group_id="O2" value="-8.6" spread="39.62"/>
                    <measurement group_id="O3" value="-60.9" spread="57.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Visit 2 to Visit 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-51.2" spread="99.99"/>
                    <measurement group_id="O2" value="-30.4" spread="96.76"/>
                    <measurement group_id="O3" value="-59.8" spread="57.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Nasal Inflammation Score Using Otoscope</title>
        <description>Nasal inflammation were graded by a clinician using a 0-3 nasal inflammation scale based on otoscope measurement where 0 = none, 1 = mild, 2 = moderate, and 3 = severe inflammation 120 minutes Post Nasal Allergen Challenge (Post-NAC).</description>
        <time_frame>Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.</time_frame>
        <population>Population includes only patients from Part 2 of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Vehicle</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
Vehicle: Vehicle, 30ml/bottle</description>
          </group>
          <group group_id="O2">
            <title>B 244 1x (Low Dose)</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle</description>
          </group>
          <group group_id="O3">
            <title>B244 4x (Mid Dose)</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle</description>
          </group>
        </group_list>
        <measure>
          <title>Nasal Inflammation Score Using Otoscope</title>
          <description>Nasal inflammation were graded by a clinician using a 0-3 nasal inflammation scale based on otoscope measurement where 0 = none, 1 = mild, 2 = moderate, and 3 = severe inflammation 120 minutes Post Nasal Allergen Challenge (Post-NAC).</description>
          <population>Population includes only patients from Part 2 of the study.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 3 (Day 14)</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4 (Day 28)</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Intranasal Nitric Oxide Levels</title>
        <description>Exhaled nasal nitric oxide (NO) was measured from the nasal cavity by a NO analyzer 120 minutes Post Nasal Allergen Challenge (Post-NAC).</description>
        <time_frame>Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.</time_frame>
        <population>Population includes only patients from Part 2 of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Vehicle</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
Vehicle: Vehicle, 30ml/bottle</description>
          </group>
          <group group_id="O2">
            <title>B 244 1x (Low Dose)</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle</description>
          </group>
          <group group_id="O3">
            <title>B244 4x (Mid Dose)</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle</description>
          </group>
        </group_list>
        <measure>
          <title>Intranasal Nitric Oxide Levels</title>
          <description>Exhaled nasal nitric oxide (NO) was measured from the nasal cavity by a NO analyzer 120 minutes Post Nasal Allergen Challenge (Post-NAC).</description>
          <population>Population includes only patients from Part 2 of the study.</population>
          <units>ppb</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 3 (Day 14)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.9" spread="57.77"/>
                    <measurement group_id="O2" value="33.9" spread="26.68"/>
                    <measurement group_id="O3" value="81.9" spread="104.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4 (Day 28)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.6" spread="55.42"/>
                    <measurement group_id="O2" value="27.3" spread="25.25"/>
                    <measurement group_id="O3" value="52.7" spread="41.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change in Cytokine Concentration in Nasal Cavity and Blood</title>
        <description>To evaluate if B244 administration will affect the levels of cytokine biomarkers in nasal cavity and blood.</description>
        <time_frame>Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.</time_frame>
        <population>Data was not collected for this exploratory endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Vehicle</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
Vehicle: Vehicle, 30ml/bottle</description>
          </group>
          <group group_id="O2">
            <title>B 244 1x (Low Dose)</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle</description>
          </group>
          <group group_id="O3">
            <title>B244 4x (Mid Dose)</title>
            <description>Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Cytokine Concentration in Nasal Cavity and Blood</title>
          <description>To evaluate if B244 administration will affect the levels of cytokine biomarkers in nasal cavity and blood.</description>
          <population>Data was not collected for this exploratory endpoint.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28).</time_frame>
      <desc>Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.</desc>
      <group_list>
        <group group_id="E1">
          <title>Part 1: Vehicle</title>
          <description>Part 1&#xD;
Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
Vehicle: Vehicle, 30ml/bottle</description>
        </group>
        <group group_id="E2">
          <title>Part 1: B244 1x (Low Dose)</title>
          <description>Part 1&#xD;
Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle</description>
        </group>
        <group group_id="E3">
          <title>Part 1: B244 4x (Mid Dose)</title>
          <description>Part 1&#xD;
Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle</description>
        </group>
        <group group_id="E4">
          <title>Part 2: Vehicle</title>
          <description>Part 2&#xD;
Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
Vehicle: Vehicle, 30ml/bottle</description>
        </group>
        <group group_id="E5">
          <title>Part 2: B244 1x (Low Dose)</title>
          <description>Part 2&#xD;
Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle</description>
        </group>
        <group group_id="E6">
          <title>Part 2: B244 4x (Mid Dose)</title>
          <description>Part 2&#xD;
Intranasal application:&#xD;
1 pump (140ul) per nostril BID for 14 days&#xD;
B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Throat irritation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Nasal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Nasal dryness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain of skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>PI may not publish or otherwise publicly disclose the analyzed study data and conclusions drawn from the study.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Hyun Kim, Vice President Clinical Operations</name_or_title>
      <organization>AOBiome Therapeutics</organization>
      <phone>617-639-9980</phone>
      <email>hkim@aobiome.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03290248
org study id: ARB244-001
nct id: NCT03290248
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a Prospective, Controlled, Double Blinded, Single Center, Randomized, 3 Arm, Parallel
      Assignment, Phase 1b/2a Study to assess the safety, tolerability, and preliminary efficacy of
      B244 delivered as an intranasal spray in healthy volunteers and subjects with seasonal
      allergic rhinitis.
This is a Prospective, Controlled, Double Blinded, Single Center, Randomized, 3 Arm, Parallel
      Assignment, Phase 1b/2a Study to assess the safety, tolerability, and preliminary efficacy of
      B244 delivered as an intranasal spray in healthy volunteers and subjects with seasonal
      allergic rhinitis. This will be a 2-part study. In Part 1, safety and tolerability will be
      evaluated during 14 days of study treatment twice-a-day followed by 4 weeks of follow-up in
      healthy volunteers. In Part 2, preliminary efficacy will be evaluated in subjects with a
      history of seasonal allergic rhinitis outside of the local pollen season.

      For Part 1 (safety and tolerability evaluation in healthy volunteers) we will enroll 24
      subjects. Safety and tolerability will be assessed by reporting of AEs, physical examination
      and vital signs (blood pressure, heart rate, respiratory rate) during 14 days of treatment
      and up to 28 days of follow-up.

      An internal safety committee meeting will review the 2 week Part 1 safety data and, if there
      are no safety concerns, the study will proceed to Part 2 to evaluate preliminary efficacy in
      subjects with a history of seasonal allergic rhinitis (SAR)

      For Part 2 (preliminary efficacy evaluation in subjects with a history of SAR to ragweed
      pollen) will enroll 42 subjects. Safety and tolerability will be assessed in subjects with
      allergic rhinitis by reporting of AEs, physical examination and vital signs (blood pressure,
      heart rate, respiratory rate) during 14 days of treatment.

      For Part 2, study will be paused for safety review using the same stopping criteria as in
      Part 1.

      Rescue medications will not be allowed during the study.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomization will be 1:1:1 so that equal number of subjects will be treated in each arm of the study.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: This is a double blind study.
measure: Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
time frame: Baseline to Day 28
description: Safety and tolerability endpoints will consist of all treatment-related adverse events reporting during the study duration for subjects only from Part 1 of the study.
measure: Change in Total Nasal Symptom Score (TNSS) After Prophylaxis Treatment
time frame: Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.
description: Total Nasal Symptom Score (TNSS) is the sum of sub-scores for each of nasal congestion, sneezing, nasal itching, and rhinorrhea at each time point, using a four point scale (0-3; 0 = none; 1 = mild; 2 = moderate; 3 = severe), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. TNSS is calculated by adding the sub-score for each of the symptoms to a total out of 12. For TNSS and Area Under the Curve (AUC) analyses, an Analysis of Covariance with treatment and site as factors and Visit 3 (or Visit 2) value as a covariate was used to test for treatment effect at Visit 4.
Observed AUC (0-2 Hours) was defined as TNSS from 0 to 120 minutes post Nasal Allergen Challenge (NAC). The Pre-NAC Adjusted AUC (0-2 Hours) was defined as the observed value minus the 0 minutes prior NAC value.
measure: Subjective Nasal Symptom Scores of Nasal Congestion After Prophylaxis Treatment
time frame: Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.
description: All measurements were taken 120 minutes Post-Nasal Allergen Challenge (Post-NAC) at Visit 4 and compared to Baseline Visit 3. Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline. Nasal congestion was categorized as None, Mild, Moderate, or Severe.
measure: Subjective Nasal Symptom Scores of Rhinorrhea After Prophylaxis Treatment
time frame: Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.
description: All measurements were taken 120 minutes Post-Nasal Allergen Challenge (Post-NAC) at Visit 4 and compared to Baseline Visit 3. Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline. Rhinorrhea was categorized as None, Mild, Moderate, or Severe.
measure: Subjective Nasal Symptom Scores of Nasal Itching After Prophylaxis Treatment
time frame: Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.
description: All measurements were taken 120 minutes Post-Nasal Allergen Challenge (Post-NAC) at Visit 4 and compared to Baseline Visit 3. Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline. Nasal itching was categorized as None, Mild, Moderate, or Severe.
measure: Subjective Nasal Symptom Scores of Sneezing After Prophylaxis Treatment
time frame: Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.
description: All measurements were taken 120 minutes Post-Nasal Allergen Challenge (Post-NAC) at Visit 4 and compared to Baseline Visit 3. Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline. Sneezing was categorized as None, Mild, Moderate, or Severe.
measure: Nasal Symptom-free Response Rate in Nasal Congestion Scores After Prophylaxis Treatment
time frame: Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.
description: Nasal symptom free response rate was assessed 120 minutes Post-Nasal Allergen Challenge (Post-NAC) to be scored as Yes or No to nasal congestion at Visit 4 (yes indicates subject is free from nasal congestion symptom and no indicates subject still has nasal itching symptom). Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline.
measure: Nasal Symptom-free Response Rate in Rhinorrhea Scores After Prophylaxis Treatment
time frame: Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.
description: Nasal symptom free response rate was assessed 120 minutes Post-Nasal Allergen Challenge (Post-NAC) to be scored as Yes or No to rhinorrhea at Visit 4 (yes indicates subject is free from rhinorrhea symptom and no indicates subject still has nasal itching symptom). Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline.
measure: Nasal Symptom-free Response Rate in Nasal Itching Scores After Prophylaxis Treatment
time frame: Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.
description: Nasal symptom free response rate was assessed 120 minutes Post-Nasal Allergen Challenge (Post-NAC) to be scored as Yes or No to nasal itching at Visit 4 (yes indicates subject is free from nasal itching symptom and no indicates subject still has nasal itching symptom). Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline.
measure: Nasal Symptom-free Response Rate in Sneezing Scores After Prophylaxis Treatment
time frame: Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.
description: Nasal symptom free response rate was assessed 120 minutes Post-Nasal Allergen Challenge (Post-NAC) to be scored as Yes or No to sneezing at Visit 4 (yes indicates subject is free from sneezing symptom and no indicates subject still has nasal itching symptom). Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline.
measure: Nasal Symptom-free Response Rate in TNSS After Prophylaxis Treatment
time frame: Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.
description: Number of subjects that had 25% and 50% reduction in Observed Area Under the Curve (AUC) (0-120 minutes)/Pre-NAC Adjusted AUC (0-120 minutes) at Visit 4 (Day 28) from Visit 2 Observed AUC (0-120 minutes)/Pre-NAC Adjusted AUC (0-120 minutes). For TNSS and Area Under the Curve (AUC) analyses, an Analysis of Covariance with treatment and site as factors and Visit 3 (or Visit 2) value as a covariate was used to test for treatment effect at Visit 4. Observed AUC (0-2 Hours) was defined as TNSS from 0 to 120 minutes post Nasal Allergen Challenge (NAC). The Pre-NAC Adjusted AUC (0-2 Hours) was defined as the observed value minus the 0 minutes prior NAC value.
measure: Change in Peak Nasal Inspiratory Flow (PNIF)
time frame: Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.
description: Peak Nasal Inspiratory Flow (PNIF) is a commonly used method for assessing nasal patency and provides an objective measurement of nasal airflow obstruction. The outcome is a direct representation of nasal congestion. Change in PNIF Observed Inverted Area Under the Curve (AUC) was measured between baseline and Visit 4. A decrease in PNIF Observed Inverted AUC(0-2 Hours) was considered an improvement in nasal airflow obstruction. Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline.
measure: Nasal Inflammation Score Using Otoscope
time frame: Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.
description: Nasal inflammation were graded by a clinician using a 0-3 nasal inflammation scale based on otoscope measurement where 0 = none, 1 = mild, 2 = moderate, and 3 = severe inflammation 120 minutes Post Nasal Allergen Challenge (Post-NAC).
measure: Intranasal Nitric Oxide Levels
time frame: Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.
description: Exhaled nasal nitric oxide (NO) was measured from the nasal cavity by a NO analyzer 120 minutes Post Nasal Allergen Challenge (Post-NAC).
measure: Change in Cytokine Concentration in Nasal Cavity and Blood
time frame: Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.
description: To evaluate if B244 administration will affect the levels of cytokine biomarkers in nasal cavity and blood.
arm group label: Vehicle
arm group type: Placebo Comparator
description: Intranasal application:
1 pump (140ul) per nostril BID for 14 days
arm group label: B 244 1x (low dose)
arm group type: Active Comparator
description: Intranasal application:
1 pump (140ul) per nostril BID for 14 days
arm group label: B244 4x (mid dose)
arm group type: Active Comparator
description: Intranasal application:
1 pump (140ul) per nostril BID for 14 days
intervention type: Biological
intervention name: B244 suspension
description: B244 suspension in 30ml/bottle
arm group label: B 244 1x (low dose)
arm group label: B244 4x (mid dose)
intervention type: Biological
intervention name: Vehicle
description: Vehicle, 30ml/bottle
arm group label: Vehicle
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Joel Neutel, MD
role: Principal Investigator
affiliation: Study PI
facility: 
facility: 
country: Canada
country: United States
responsible party type: Sponsor
mesh term: Rhinitis
mesh term: Rhinitis, Allergic
mesh term: Rhinitis, Allergic, Seasonal
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 