<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/NCT01723397</url>
  </required_header>
  <id_info>
    <org_study_id>12-1252</org_study_id>
    <nct_id>NCT01723397</nct_id>
  </id_info>
  <brief_title>Effect of Nasaleze on Nasal Challenge With Allergen</brief_title>
  <official_title>Effect of Nasaleze on the Early Reaction to Nasal Challenge With Allergen</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Chicago</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objectives of this protocol are:&#xD;
&#xD;
        1. to confirm the inhibitory effect of Nasaleze on the immediate response to nasal&#xD;
           challenge with antigen, and&#xD;
&#xD;
        2. to show that inhibition of the immediate response to nasal challenge with antigen by&#xD;
           Nasaleze inhibits subsequent inflammatory events.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Poor recruitment&#xD;
  </why_stopped>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Total Nasal Symptom Score After Nasal Challenge With Allergen Versus Diluent</measure>
    <time_frame>Day 2 after one week pretreatment with Nasaleze or placebo.</time_frame>
    <description>Change in total nasal symptom score after nasal challenges (the change is calculated as the total nasal symptom score after allergen challenge - total nasal symptom score after diluent challenge) on the second of two days of nasal challenges following one week of pretreatment with Nasaleze or placebo. The nasal symptoms included number of sneezes, symptoms of runny and stuffy nose (separately for each nostril), and itchy nose/throat symptoms. Individual symptoms were score on a scale from 0-3 (0=no symptoms, 1=mild, 2=moderate, 3=severe). The maximum total nasal symptom score possible was 15 with higher scores indicating worse symptoms.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Allergic Rhinitis</condition>
  <arm_group>
    <arm_group_label>Nasaleze spray</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nasaleze spray 1 puff via &quot;spray device&quot; in each nostril 3 times daily for 1 week followed by allergen challenge</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo spray</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo spray 1 puff via &quot;spray device&quot; in each nostril 3 times daily for 1 week followed by allergen challenge</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nasaleze Spray</intervention_name>
    <description>Subjects are treated with over the counter Nasaleze cellulose powder nasal spray then challenged with allergen</description>
    <arm_group_label>Nasaleze spray</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo spray</intervention_name>
    <description>Subjects are treated with placebo nasal spray then challenged with allergen</description>
    <arm_group_label>Placebo spray</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Allergen</intervention_name>
    <description>Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo</description>
    <arm_group_label>Nasaleze spray</arm_group_label>
    <arm_group_label>Placebo spray</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Males and females between 18 and 45 years of age.&#xD;
&#xD;
          2. History of grass and/or ragweed allergic rhinitis.&#xD;
&#xD;
          3. Positive skin test to grass and/or ragweed antigen.&#xD;
&#xD;
          4. Positive response to screening nasal challenge.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.&#xD;
&#xD;
          2. Pregnant or lactating women.&#xD;
&#xD;
          3. Upper respiratory infection within 14 days of study start.&#xD;
&#xD;
          4. FEV1&lt;80% of predicted at screening for subjects with history of mild asthma.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert M Naclerio, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <results_first_submitted>September 6, 2016</results_first_submitted>
  <results_first_submitted_qc>September 6, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 27, 2016</results_first_posted>
  <last_update_submitted>November 7, 2016</last_update_submitted>
  <last_update_submitted_qc>November 7, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 2, 2017</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>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Nasaleze Spray, Then Placebo Spray</title>
          <description>This group first received Nasaleze spray 1 puff via &quot;spray device&quot; in each nostril 3 times daily for 1 week followed by allergen (either grass or ragweed) challenge, then after a 1 week washout received placebo spray 1 puff via &quot;spray device&quot; in each nostril 3 times daily for 1 week followed by allergen challenge</description>
        </group>
        <group group_id="P2">
          <title>Placebo Spray, Then Nasaleze Spray</title>
          <description>This group first received Placebo spray 1 puff via &quot;spray device&quot; in each nostril 3 times daily for 1 week followed by allergen (grass or ragweed) challenge, followed by a 1 week washout and then received Nasaleze spray 1 puff via &quot;spray device&quot; in each nostril 3 times daily for 1 week followed by allergen challenge</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Study Period 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Washout</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Study Period 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Nasaleze Spray, Then Placebo Spray</title>
          <description>This group first received Nasaleze spray 1 puff via &quot;spray device&quot; in each nostril 3 times daily for 1 week followed by allergen (either grass or ragweed) challenge, then after a 1 week washout received placebo spray 1 puff via &quot;spray device&quot; in each nostril 3 times daily for 1 week followed by allergen challenge</description>
        </group>
        <group group_id="B2">
          <title>Placebo Spray, Then Nasaleze Spray</title>
          <description>This group first received placebo spray 1 puff via &quot;spray device&quot; in each nostril 3 times daily for 1 week followed by allergen (either grass or ragweed) challenge, then after a 1 week washout received Nasaleze spray 1 puff via &quot;spray device&quot; in each nostril 3 times daily for 1 week followed by allergen challenge</description>
        </group>
        <group group_id="B3">
          <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="7"/>
            <count group_id="B2" value="7"/>
            <count group_id="B3" value="14"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23.6" spread="8.6"/>
                    <measurement group_id="B2" value="28.0" spread="7.5"/>
                    <measurement group_id="B3" value="25.8" spread="8.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Total Nasal Symptom Score After Nasal Challenge With Allergen Versus Diluent</title>
        <description>Change in total nasal symptom score after nasal challenges (the change is calculated as the total nasal symptom score after allergen challenge - total nasal symptom score after diluent challenge) on the second of two days of nasal challenges following one week of pretreatment with Nasaleze or placebo. The nasal symptoms included number of sneezes, symptoms of runny and stuffy nose (separately for each nostril), and itchy nose/throat symptoms. Individual symptoms were score on a scale from 0-3 (0=no symptoms, 1=mild, 2=moderate, 3=severe). The maximum total nasal symptom score possible was 15 with higher scores indicating worse symptoms.</description>
        <time_frame>Day 2 after one week pretreatment with Nasaleze or placebo.</time_frame>
        <population>The analysis population includes the 12 participants who completed the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Nasaleze Spray</title>
            <description>Nasaleze spray 1 puff via &quot;spray device&quot; in each nostril 3 times daily for 1 week followed by allergen challenge&#xD;
Nasaleze Spray: Subjects are treated with over the counter Nasaleze cellulose powder nasal spray then challenged with allergen&#xD;
Allergen: Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo</description>
          </group>
          <group group_id="O2">
            <title>Placebo Spray</title>
            <description>Placebo spray 1 puff via &quot;spray device&quot; in each nostril 3 times daily for 1 week followed by allergen challenge&#xD;
Placebo spray: Subjects are treated with placebo nasal spray then challenged with allergen&#xD;
Allergen: Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Total Nasal Symptom Score After Nasal Challenge With Allergen Versus Diluent</title>
          <description>Change in total nasal symptom score after nasal challenges (the change is calculated as the total nasal symptom score after allergen challenge - total nasal symptom score after diluent challenge) on the second of two days of nasal challenges following one week of pretreatment with Nasaleze or placebo. The nasal symptoms included number of sneezes, symptoms of runny and stuffy nose (separately for each nostril), and itchy nose/throat symptoms. Individual symptoms were score on a scale from 0-3 (0=no symptoms, 1=mild, 2=moderate, 3=severe). The maximum total nasal symptom score possible was 15 with higher scores indicating worse symptoms.</description>
          <population>The analysis population includes the 12 participants who completed the study.</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" lower_limit="1" upper_limit="13"/>
                    <measurement group_id="O2" value="5.5" lower_limit="1" upper_limit="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.8</p_value>
            <method>Wilcoxon signed-rank test</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>4 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Nasaleze Spray</title>
          <description>Nasaleze spray 1 puff via &quot;spray device&quot; in each nostril 3 times daily for 1 week followed by allergen challenge&#xD;
Nasaleze Spray: Subjects are treated with over the counter Nasaleze cellulose powder nasal spray then challenged with allergen&#xD;
Allergen: Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo</description>
        </group>
        <group group_id="E2">
          <title>Placebo Spray</title>
          <description>Placebo spray 1 puff via &quot;spray device&quot; in each nostril 3 times daily for 1 week followed by allergen challenge&#xD;
Placebo spray: Subjects are treated with placebo nasal spray then challenged with allergen&#xD;
Allergen: Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Robert Naclerio</name_or_title>
      <organization>University of Chicago</organization>
      <phone>773-702-0080</phone>
      <email>rnacleri@surgery.bsd.uchicago.edu</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/NCT01723397
org study id: 12-1252
nct id: NCT01723397
lead sponsor: 
has dmc: No
The objectives of this protocol are:

        1. to confirm the inhibitory effect of Nasaleze on the immediate response to nasal
           challenge with antigen, and

        2. to show that inhibition of the immediate response to nasal challenge with antigen by
           Nasaleze inhibits subsequent inflammatory events.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in Total Nasal Symptom Score After Nasal Challenge With Allergen Versus Diluent
time frame: Day 2 after one week pretreatment with Nasaleze or placebo.
description: Change in total nasal symptom score after nasal challenges (the change is calculated as the total nasal symptom score after allergen challenge - total nasal symptom score after diluent challenge) on the second of two days of nasal challenges following one week of pretreatment with Nasaleze or placebo. The nasal symptoms included number of sneezes, symptoms of runny and stuffy nose (separately for each nostril), and itchy nose/throat symptoms. Individual symptoms were score on a scale from 0-3 (0=no symptoms, 1=mild, 2=moderate, 3=severe). The maximum total nasal symptom score possible was 15 with higher scores indicating worse symptoms.
arm group label: Nasaleze spray
arm group type: Active Comparator
description: Nasaleze spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge
arm group label: Placebo spray
arm group type: Placebo Comparator
description: Placebo spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge
intervention type: Drug
intervention name: Nasaleze Spray
description: Subjects are treated with over the counter Nasaleze cellulose powder nasal spray then challenged with allergen
arm group label: Nasaleze spray
intervention type: Other
intervention name: Placebo spray
description: Subjects are treated with placebo nasal spray then challenged with allergen
arm group label: Placebo spray
intervention type: Biological
intervention name: Allergen
description: Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo
arm group label: Nasaleze spray
arm group label: Placebo spray
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Robert M Naclerio, MD
role: Principal Investigator
affiliation: University of Chicago
facility: 
country: United States
responsible party type: Sponsor
mesh term: Rhinitis
mesh term: Rhinitis, Allergic
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 