<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/NCT02230696</url>
  </required_header>
  <id_info>
    <org_study_id>PRG-NY-14-018</org_study_id>
    <nct_id>NCT02230696</nct_id>
  </id_info>
  <brief_title>Comparative Safety and Efficacy of Two Steroid Treatments in the Relief of the Symptoms of Seasonal Allergic Rhinitis</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Padagis LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Padagis LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare safety and efficacy of Perrigo's steroid drug product compared with an FDA&#xD;
      approved steroid drug product in the treatment of subjects with seasonal allergic rhinitis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Change From Baseline for Mean Reflective Total Nasal Symptom Score (rTNSS)</measure>
    <time_frame>Day 1 through Day 14</time_frame>
    <description>The symptoms included in the reflective Total Nasal Symptom Score (rTNSS) scale are nasal congestion/stuffy nose, nasal discharge/runny nose, sneezing, and itchy nose. Symptoms were scored on a four point scale, 0-3, for each assessment were calculated by totaling these four symptom scores for a maximum score of 12.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in the Mean Instantaneous Total Nasal Symptom Score (iTNSS)</measure>
    <time_frame>Day 1 through Day 14</time_frame>
    <description>The symptoms included in the instantaneous Total Nasal Symptom Score (iTNSS) scale are nasal congestion/stuffy nose, nasal discharge/runny nose, sneezing, and itchy nose. Symptoms were scored on a four point scale, 0-3, for each assessment were calculated by totaling these four symptom scores for a maximum score of 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline iTNSS Scores on Day 1 Post First Randomized Dose</measure>
    <time_frame>Day 1, up to four hours post the first dose</time_frame>
    <description>This outcome measured the time to statistical significance of the reduction of signs/symptoms over a 4 hour period on Day 1 only by measuring the reduction in iTNSS scores. When the change from baseline was statistically significant, it was associated with a time to onset of the anti-histamine component of the formulation.&#xD;
Subjects will record iTNSS scores for 4 hours post first randomized dose. The symptoms included in the instantaneous Total Nasal Symptom Score (iTNSS) scale are nasal congestion/stuffy nose, nasal discharge/runny nose, sneezing, and itchy nose. Symptoms were scored on a four point scale, 0-3, for each assessment were calculated by totaling these four symptom scores for a maximum score of 12.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">951</enrollment>
  <condition>Seasonal Allergic Rhinitis</condition>
  <arm_group>
    <arm_group_label>Test Product</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray - Perrigo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reference Product</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray - Meda</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Product</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo nasal spray</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray</intervention_name>
    <description>137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate</description>
    <arm_group_label>Test Product</arm_group_label>
    <other_name>Perrigo Product</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray</intervention_name>
    <description>137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate</description>
    <arm_group_label>Reference Product</arm_group_label>
    <other_name>Reference Listed Drug Product</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo nasal spray</intervention_name>
    <description>Placebo nasal spray</description>
    <arm_group_label>Placebo Product</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Complete the informed consent/assent process.&#xD;
&#xD;
          2. Male or female between 12 to 65 years of age, inclusive.&#xD;
&#xD;
          3. Females of childbearing potential willing to use an acceptable form of birth control&#xD;
             during the study.&#xD;
&#xD;
          4. Moderate-to-severe allergic rhinitis.&#xD;
&#xD;
          5. At Visits 1 and 2 have instantaneous and reflective symptom scores sufficient enough&#xD;
             to qualify for continued participation in the study&#xD;
&#xD;
          6. Subject must have a history (for 2 or more seasons) of seasonal allergy to at least&#xD;
             one allergen known to be present during the study season.&#xD;
&#xD;
          7. Subject must be in general good health with no clinically significant disease or&#xD;
             medical procedure other than allergic rhinitis within various time periods prior to&#xD;
             Visit 1.&#xD;
&#xD;
          8. Subject must be willing and able to understand and comply with the requirements of the&#xD;
             study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Female who is pregnant or nursing, who is not using or does not agree to use an&#xD;
             acceptable form of contraception during the study, or who intends to become pregnant&#xD;
             during the study.&#xD;
&#xD;
          2. Subject has a history of hypersensitivity or allergy to any ingredient in the drug&#xD;
             products.&#xD;
&#xD;
          3. Subject has any condition or abnormality of the upper airway that, in the opinion of&#xD;
             the Investigator, could interfere with administration of the product, evaluation of&#xD;
             the subject's condition, or other aspect of the trial.&#xD;
&#xD;
          4. The presence of any nasal mucosal crusting, erosion, ulceration, nasal septum&#xD;
             perforation, or any kind of blockage of the nasal passages at screening or&#xD;
             randomization.&#xD;
&#xD;
          5. Subject has asthma or a history of asthma requiring chronic treatment within two years&#xD;
             of Visit 1.&#xD;
&#xD;
          6. Treatment for oral Candidiasis within 30 days of starting the study, or a current oral&#xD;
             Candidiasis infection.&#xD;
&#xD;
          7. Subject has had recent exposure (30 days) or is at risk of being exposed to chicken&#xD;
             pox or measles.&#xD;
&#xD;
          8. Subjects with any untreated fungal, bacterial, systemic viral infections within the&#xD;
             previous 30 days.&#xD;
&#xD;
          9. Use of various therapies within the given time period prior to Visit 1 and throughout&#xD;
             the study.&#xD;
&#xD;
         10. Initiation of hormone replacement therapy during the study.&#xD;
&#xD;
         11. Initiation of immunotherapy during the study, or changes in dosage or frequency of&#xD;
             immunotherapy within the 30 days preceding Visit 1.&#xD;
&#xD;
         12. Subject has received immune-system therapy or peptide immunotherapy of any form.&#xD;
&#xD;
         13. Subject had desensitization therapy to the seasonal allergen that is causing their&#xD;
             allergic rhinitis within the previous 6 months.&#xD;
&#xD;
         14. Subject presented with conjunctivitis or any other eye signs/symptoms that are not&#xD;
             related to the diagnosis of SAR.&#xD;
&#xD;
         15. Clinically relevant abnormal physical findings or medication use within 1 week of&#xD;
             randomization, which, in the opinion of the investigator, might interfere with the&#xD;
             conduct or results of the study or place the prospective subject at increased risk.&#xD;
&#xD;
         16. Subjects being treated with a product containing a sympathomimetic agent.&#xD;
&#xD;
         17. Subject has previously enrolled in this study or is enrolled in this study with&#xD;
             another participating investigator site.&#xD;
&#xD;
         18. Subject is concurrently participating in another investigational study or using any&#xD;
             investigational drug (or biologic) or device.&#xD;
&#xD;
         19. Subject plans or anticipates travel outside the local allergen area at any point in&#xD;
             the study.&#xD;
&#xD;
         20. History of unresponsiveness to steroid nasal sprays for SAR symptoms.&#xD;
&#xD;
         21. Employee (or employee's family member) of the research center or private practice.&#xD;
&#xD;
         22. If the subject has a smoking history of greater than 10 pack years or has recently&#xD;
             started or re-started smoking within the past 2 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Atlanta Allergy &amp; Asthma Clinic, PA</name>
      <address>
        <city>Stockbridge</city>
        <state>Georgia</state>
        <zip>30281</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Atlanta (CRA)</name>
      <address>
        <city>Stockbridge</city>
        <state>Georgia</state>
        <zip>30281</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Family Allergy and Asthma Research Institute</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chesapeake Clinical Research, Inc.</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NEMRA Northeast Medical Research Associates, Inc</name>
      <address>
        <city>North Dartmouth</city>
        <state>Massachusetts</state>
        <zip>02747</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Institute, Inc.</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55402</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Institute LLC</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research of the Ozarks, Inc.</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research of the Ozarks, Inc.</name>
      <address>
        <city>Rolla</city>
        <state>Missouri</state>
        <zip>65401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Clinical Research Center, LLC</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princeton Center for Clinical Research</name>
      <address>
        <city>Skillman</city>
        <state>New Jersey</state>
        <zip>08558</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Island Medical Research, P.C.</name>
      <address>
        <city>Rockville Centre</city>
        <state>New York</state>
        <zip>11570</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy and Asthma Center of NC</name>
      <address>
        <city>High Point</city>
        <state>North Carolina</state>
        <zip>27262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Carolina Clinical Research</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toledo Center for Clinical Research</name>
      <address>
        <city>Sylvania</city>
        <state>Ohio</state>
        <zip>43560</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy, Asthma &amp; Clinical Research Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vital Prospects Clinical Research Institute, P.C.</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Allergy, Asthma &amp; Urticaria Centers of Charleston</name>
      <address>
        <city>North Charleston</city>
        <state>South Carolina</state>
        <zip>29420</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Phase Research and Development</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37919</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ISIS Clinical Research, LLC</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sirius Clinical Research LLC</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78759</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AARA Research Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmaceutical Research &amp; Consulting Inc.</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western Sky Medical Research</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Texas Health Research</name>
      <address>
        <city>New Braunfels</city>
        <state>Texas</state>
        <zip>78130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quality Research Inc.</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diagnostics Research Group</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sylvana Research Associates</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78257</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy Asthma Research Institute</name>
      <address>
        <city>Waco</city>
        <state>Texas</state>
        <zip>76712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Asthma &amp; Allergy Center - Bellevue</name>
      <address>
        <city>Bellevue</city>
        <state>Washington</state>
        <zip>68123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <results_first_submitted>January 8, 2021</results_first_submitted>
  <results_first_submitted_qc>February 19, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">March 15, 2021</results_first_posted>
  <disposition_first_submitted>July 1, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>July 1, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">July 23, 2015</disposition_first_posted>
  <last_update_submitted>October 20, 2021</last_update_submitted>
  <last_update_submitted_qc>October 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2021</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluticasone</mesh_term>
    <mesh_term>Xhance</mesh_term>
    <mesh_term>Azelastine</mesh_term>
  </intervention_browse>
  <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>September 2, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/96/NCT02230696/Prot_001.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>September 2, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/96/NCT02230696/SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Test Product</title>
          <description>Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray - Perrigo</description>
        </group>
        <group group_id="P2">
          <title>Reference Product</title>
          <description>Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray Meda</description>
        </group>
        <group group_id="P3">
          <title>Placebo Product</title>
          <description>Placebo nasal spray</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="381"/>
                <participants group_id="P2" count="376"/>
                <participants group_id="P3" count="194"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="366"/>
                <participants group_id="P2" count="365"/>
                <participants group_id="P3" count="190"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Test Product</title>
          <description>Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray&#xD;
Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray: 137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate</description>
        </group>
        <group group_id="B2">
          <title>Reference Product</title>
          <description>Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray: 137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate</description>
        </group>
        <group group_id="B3">
          <title>Placebo Product</title>
          <description>Placebo nasal spray&#xD;
Placebo nasal spray</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="381"/>
            <count group_id="B2" value="376"/>
            <count group_id="B3" value="194"/>
            <count group_id="B4" value="951"/>
          </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="37.5" spread="12.87"/>
                    <measurement group_id="B2" value="38.6" spread="13.28"/>
                    <measurement group_id="B3" value="38.4" spread="13.07"/>
                    <measurement group_id="B4" value="38.1" spread="13.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</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="250"/>
                    <measurement group_id="B2" value="248"/>
                    <measurement group_id="B3" value="123"/>
                    <measurement group_id="B4" value="621"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="131"/>
                    <measurement group_id="B2" value="128"/>
                    <measurement group_id="B3" value="71"/>
                    <measurement group_id="B4" value="330"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="30"/>
                    <measurement group_id="B4" value="141"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="329"/>
                    <measurement group_id="B2" value="316"/>
                    <measurement group_id="B3" value="164"/>
                    <measurement group_id="B4" value="809"/>
                  </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="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="6"/>
                  </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="85"/>
                    <measurement group_id="B2" value="81"/>
                    <measurement group_id="B3" value="41"/>
                    <measurement group_id="B4" value="207"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="283"/>
                    <measurement group_id="B2" value="285"/>
                    <measurement group_id="B3" value="148"/>
                    <measurement group_id="B4" value="716"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Change From Baseline for Mean Reflective Total Nasal Symptom Score (rTNSS)</title>
        <description>The symptoms included in the reflective Total Nasal Symptom Score (rTNSS) scale are nasal congestion/stuffy nose, nasal discharge/runny nose, sneezing, and itchy nose. Symptoms were scored on a four point scale, 0-3, for each assessment were calculated by totaling these four symptom scores for a maximum score of 12.</description>
        <time_frame>Day 1 through Day 14</time_frame>
        <population>Per protocol population</population>
        <group_list>
          <group group_id="O1">
            <title>Test Product</title>
            <description>Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray - Perrigo</description>
          </group>
          <group group_id="O2">
            <title>Reference Product</title>
            <description>Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray - Meda</description>
          </group>
          <group group_id="O3">
            <title>Placebo Nasal Spray</title>
            <description>Placebo nasal spray</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline for Mean Reflective Total Nasal Symptom Score (rTNSS)</title>
          <description>The symptoms included in the reflective Total Nasal Symptom Score (rTNSS) scale are nasal congestion/stuffy nose, nasal discharge/runny nose, sneezing, and itchy nose. Symptoms were scored on a four point scale, 0-3, for each assessment were calculated by totaling these four symptom scores for a maximum score of 12.</description>
          <population>Per protocol population</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="349"/>
                <count group_id="O2" value="349"/>
                <count group_id="O3" value="181"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.95" spread=".15"/>
                    <measurement group_id="O2" value="-3.13" spread=".15"/>
                    <measurement group_id="O3" value="-1.98" spread=".19"/>
                  </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>Equivalence</non_inferiority_type>
            <non_inferiority_desc>provides 85% power of success</non_inferiority_desc>
            <param_type>Equivalence ratio</param_type>
            <param_value>94.19</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>84.77</ci_lower_limit>
            <ci_upper_limit>104.52</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in the Mean Instantaneous Total Nasal Symptom Score (iTNSS)</title>
        <description>The symptoms included in the instantaneous Total Nasal Symptom Score (iTNSS) scale are nasal congestion/stuffy nose, nasal discharge/runny nose, sneezing, and itchy nose. Symptoms were scored on a four point scale, 0-3, for each assessment were calculated by totaling these four symptom scores for a maximum score of 12.</description>
        <time_frame>Day 1 through Day 14</time_frame>
        <population>per-protocol population</population>
        <group_list>
          <group group_id="O1">
            <title>Test Product</title>
            <description>Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray - Perrigo</description>
          </group>
          <group group_id="O2">
            <title>Reference Product</title>
            <description>Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray - Meda</description>
          </group>
          <group group_id="O3">
            <title>Placebo Nasal Spray</title>
            <description>Placebo nasal spray</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in the Mean Instantaneous Total Nasal Symptom Score (iTNSS)</title>
          <description>The symptoms included in the instantaneous Total Nasal Symptom Score (iTNSS) scale are nasal congestion/stuffy nose, nasal discharge/runny nose, sneezing, and itchy nose. Symptoms were scored on a four point scale, 0-3, for each assessment were calculated by totaling these four symptom scores for a maximum score of 12.</description>
          <population>per-protocol population</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="349"/>
                <count group_id="O2" value="349"/>
                <count group_id="O3" value="181"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.81" spread="0.15"/>
                    <measurement group_id="O2" value="-2.96" spread="0.15"/>
                    <measurement group_id="O3" value="-1.88" spread=".19"/>
                  </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>Equivalence</non_inferiority_type>
            <non_inferiority_desc>provides 85% power of success</non_inferiority_desc>
            <param_type>Equivalence ratio</param_type>
            <param_value>94.68</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>84.86</ci_lower_limit>
            <ci_upper_limit>105.54</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline iTNSS Scores on Day 1 Post First Randomized Dose</title>
        <description>This outcome measured the time to statistical significance of the reduction of signs/symptoms over a 4 hour period on Day 1 only by measuring the reduction in iTNSS scores. When the change from baseline was statistically significant, it was associated with a time to onset of the anti-histamine component of the formulation.&#xD;
Subjects will record iTNSS scores for 4 hours post first randomized dose. The symptoms included in the instantaneous Total Nasal Symptom Score (iTNSS) scale are nasal congestion/stuffy nose, nasal discharge/runny nose, sneezing, and itchy nose. Symptoms were scored on a four point scale, 0-3, for each assessment were calculated by totaling these four symptom scores for a maximum score of 12.</description>
        <time_frame>Day 1, up to four hours post the first dose</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test Product</title>
            <description>Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray - Perrigo</description>
          </group>
          <group group_id="O2">
            <title>Reference Product</title>
            <description>Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray - Meda</description>
          </group>
          <group group_id="O3">
            <title>Placebo Nasal Spray</title>
            <description>Placebo nasal spray</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline iTNSS Scores on Day 1 Post First Randomized Dose</title>
          <description>This outcome measured the time to statistical significance of the reduction of signs/symptoms over a 4 hour period on Day 1 only by measuring the reduction in iTNSS scores. When the change from baseline was statistically significant, it was associated with a time to onset of the anti-histamine component of the formulation.&#xD;
Subjects will record iTNSS scores for 4 hours post first randomized dose. The symptoms included in the instantaneous Total Nasal Symptom Score (iTNSS) scale are nasal congestion/stuffy nose, nasal discharge/runny nose, sneezing, and itchy nose. Symptoms were scored on a four point scale, 0-3, for each assessment were calculated by totaling these four symptom scores for a maximum score of 12.</description>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="343"/>
                <count group_id="O2" value="343"/>
                <count group_id="O3" value="181"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.41" spread="0.15"/>
                    <measurement group_id="O2" value="-3.29" spread="0.15"/>
                    <measurement group_id="O3" value="-2.94" spread=".20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>14 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Test Product</title>
          <description>Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray&#xD;
Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray: 137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate</description>
        </group>
        <group group_id="E2">
          <title>Reference Product</title>
          <description>Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray: 137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate</description>
        </group>
        <group group_id="E3">
          <title>Placebo Product</title>
          <description>Placebo nasal spray&#xD;
Placebo nasal spray</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <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="381"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="194"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="381"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="194"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infected cat bite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="381"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="194"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>cervical disc herniation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="381"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="194"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Fetal demise</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="381"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="194"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>suicidal ideations</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="381"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="194"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="381"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="194"/>
              </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>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jonathan Schwartz</name_or_title>
      <organization>Perrigo</organization>
      <phone>718-960-9900</phone>
      <email>jonathan.schwartz@perrigo.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/NCT02230696
org study id: PRG-NY-14-018
nct id: NCT02230696
lead sponsor: 
has dmc: No
To compare safety and efficacy of Perrigo's steroid drug product compared with an FDA
      approved steroid drug product in the treatment of subjects with seasonal allergic rhinitis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Mean Change From Baseline for Mean Reflective Total Nasal Symptom Score (rTNSS)
time frame: Day 1 through Day 14
description: The symptoms included in the reflective Total Nasal Symptom Score (rTNSS) scale are nasal congestion/stuffy nose, nasal discharge/runny nose, sneezing, and itchy nose. Symptoms were scored on a four point scale, 0-3, for each assessment were calculated by totaling these four symptom scores for a maximum score of 12.
measure: Mean Change From Baseline in the Mean Instantaneous Total Nasal Symptom Score (iTNSS)
time frame: Day 1 through Day 14
description: The symptoms included in the instantaneous Total Nasal Symptom Score (iTNSS) scale are nasal congestion/stuffy nose, nasal discharge/runny nose, sneezing, and itchy nose. Symptoms were scored on a four point scale, 0-3, for each assessment were calculated by totaling these four symptom scores for a maximum score of 12.
measure: Change From Baseline iTNSS Scores on Day 1 Post First Randomized Dose
time frame: Day 1, up to four hours post the first dose
description: This outcome measured the time to statistical significance of the reduction of signs/symptoms over a 4 hour period on Day 1 only by measuring the reduction in iTNSS scores. When the change from baseline was statistically significant, it was associated with a time to onset of the anti-histamine component of the formulation.
Subjects will record iTNSS scores for 4 hours post first randomized dose. The symptoms included in the instantaneous Total Nasal Symptom Score (iTNSS) scale are nasal congestion/stuffy nose, nasal discharge/runny nose, sneezing, and itchy nose. Symptoms were scored on a four point scale, 0-3, for each assessment were calculated by totaling these four symptom scores for a maximum score of 12.
arm group label: Test Product
arm group type: Experimental
description: Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray - Perrigo
arm group label: Reference Product
arm group type: Active Comparator
description: Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray - Meda
arm group label: Placebo Product
arm group type: Placebo Comparator
description: Placebo nasal spray
intervention type: Drug
intervention name: Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray
description: 137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate
arm group label: Test Product
other name: Perrigo Product
intervention type: Drug
intervention name: Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray
description: 137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate
arm group label: Reference Product
other name: Reference Listed Drug Product
intervention type: Drug
intervention name: Placebo nasal spray
description: Placebo nasal spray
arm group label: Placebo Product
criteria: 
gender: All
minimum age: 12 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
facility: 
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facility: 
country: United States
responsible party type: Sponsor
mesh term: Rhinitis
mesh term: Rhinitis, Allergic
mesh term: Rhinitis, Allergic, Seasonal
mesh term: Fluticasone
mesh term: Xhance
mesh term: Azelastine
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 