<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/NCT02249663</url>
  </required_header>
  <id_info>
    <org_study_id>71336006</org_study_id>
    <nct_id>NCT02249663</nct_id>
  </id_info>
  <brief_title>Clinical Equivalence of Azelastine Hydrochloride and Fluticasone Propionate, 137/50 mcg Nasal Spray to Dymista™</brief_title>
  <official_title>A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multi-Site Study to Evaluate the Therapeutic Equivalence of Azelastine Hydrochloride and Fluticasone Propionate, 137/50 mcg Nasal Spray, to Dymista™ Nasal Spray</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Teva Pharmaceuticals USA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Teva Pharmaceuticals USA</source>
  <brief_summary>
    <textblock>
      To evaluate the therapeutic equivalence of a test formulation of Azelastine hydrochloride and&#xD;
      Fluticasone propionate Nasal Spray to the reference listed drug, Dymista™ Nasal Spray in the&#xD;
      relief of the signs and symptoms of Seasonal Allergic Rhinitis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <primary_completion_date type="Anticipated">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>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in average AM/PM reflective Total Nasal Symptom Score (rTNSS).</measure>
    <time_frame>Days 1 to 14</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in average instantaneous Total Nasal Symptom Score (iTNSS).</measure>
    <time_frame>Days 1 to 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in average reflective Total Ocular Symptom Score (iTOSS).</measure>
    <time_frame>Days 1 to 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in average instantaneous Total Ocular Symptom Score (iTOSS).</measure>
    <time_frame>Days 1 to 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Onset of Action</measure>
    <time_frame>4 hours post dose</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">1535</enrollment>
  <condition>Seasonal Allergic Rhinitis</condition>
  <arm_group>
    <arm_group_label>Investigational Test Product</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Azelastine hydrochloride and Fluticasone propionate Nasal Spray, 137/50 mcg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reference Listed Drug</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dymista™ (azelastine hydrochloride/fluticasone propionate) Nasal Spray, 137/50 mcg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</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 and Fluticasone propionate</intervention_name>
    <description>137/50 mcg Nasal Spray</description>
    <arm_group_label>Investigational Test Product</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dymista™</intervention_name>
    <description>137/50 mcg Nasal Spray</description>
    <arm_group_label>Reference Listed Drug</arm_group_label>
    <other_name>Azelastine hydrochloride and Fluticasone propionate (generic name)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Nasal spray with no pharmaceutically active content</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or non-pregnant, non-lactating female 12 years of age or older.&#xD;
&#xD;
          -  Signed informed consent form, which meets all criteria of current FDA regulations. For&#xD;
             patients under the age of majority in the state the study is being conducted (18 years&#xD;
             in most states) the parent or legal guardian should sign the consent form and the&#xD;
             child will be required to sign a patient &quot;assent&quot; form that will be written in such a&#xD;
             way to be understandable to a child.&#xD;
&#xD;
          -  Documented positive allergic skin test, performed within the previous 12 months, to&#xD;
             one or more of the allergens in season at the time the study is being conducted.&#xD;
&#xD;
          -  A minimum of two consecutive years of previous history of Seasonal Allergic Rhinitis&#xD;
             (SAR) to the pollen/allergen in season at the time the study is being conducted.&#xD;
&#xD;
          -  Eligibility requirements for placebo lead-in period: A total (composite) score of at&#xD;
             least 6 on the reflective Total Nasal Symptom Score (rTNSS) with a minimum of at least&#xD;
             2 for &quot;nasal congestion&quot; and a minimum score of at least 2 for one of the remaining 3&#xD;
             symptoms and total (composite) score of at least 4 on the reflective Total Ocular&#xD;
             Symptom Score (rTOSS). These scores represent the 12 hours before the screening visit.&#xD;
&#xD;
          -  In addition to requirements above, patients should have the following at the end of&#xD;
             the placebo lead-in period and before randomization: 1) average composite score of at&#xD;
             least 6 on the rTNSS with a minimum average score of at least 2 for &quot;nasal congestion&quot;&#xD;
             and a minimum average score of at least 2 for one of the remaining 3 symptoms, and 2)&#xD;
             average composite score of at least 4 on the rTOSS. These scores represent the 3 days&#xD;
             of the 7 day placebo run-in period before the Randomization visit and the morning of&#xD;
             the first day of the Randomization visit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 12 years of age.&#xD;
&#xD;
          -  Females who are pregnant, lactating, or likely to become pregnant during the study.&#xD;
&#xD;
          -  Negative or lack of documented skin allergen test (performed within the previous 12&#xD;
             months) to at least one of the allergens in season at the time the study is being&#xD;
             conducted. The results of all positive skin allergen test results should be reported.&#xD;
&#xD;
          -  Patients who suffer from chronic signs and symptoms of Perennial Allergic Rhinitis&#xD;
             (PAR) should be excluded from the study unless the Investigator assesses that the&#xD;
             patient's current signs and symptoms are a clear exacerbation of Seasonal Allergic&#xD;
             Rhinitis (SAR) rather than the chronic PAR.&#xD;
&#xD;
          -  Patients who suffer only from PAR or SAR to a different allergen than that in season&#xD;
             at the time the study is conducted.&#xD;
&#xD;
          -  Previous history of less than 2 years of SAR to the pollen/allergen in season at the&#xD;
             time the study is conducted.&#xD;
&#xD;
          -  Before the placebo lead-in period, the patient has a total score of less than 6 on the&#xD;
             rTNSS or a score less than 2 for &quot;nasal congestion&quot;. Any patient who meets the minimum&#xD;
             individual nasal symptom score requirements at the start of the placebo lead-in period&#xD;
             but no longer meets the requirements prior to the randomized active treatment period&#xD;
             of the study cannot continue in the active treatment period.&#xD;
&#xD;
          -  At the end of the placebo lead-in period and before randomization, the patient has an&#xD;
             average composite score of less than 6 on the rTNSS and an average composite score of&#xD;
             less than 4 on the rTOSS.&#xD;
&#xD;
          -  History of asthma over the previous 2 years that required chronic therapy. Occasional&#xD;
             acute or mild exercise induced asthma will be allowable on the condition that the&#xD;
             treatment of the attacks is restricted to beta-agonists only.&#xD;
&#xD;
          -  Patients with nasal conditions, including infectious rhinitis, rhinitis medicamentosa,&#xD;
             or atrophic rhinitis.&#xD;
&#xD;
          -  Clinically significant nasal deformity or any recent nasal surgery or trauma that has&#xD;
             not completely healed.&#xD;
&#xD;
          -  Sinus infection within the previous 30 days or history or re-occurring sinus&#xD;
             infections.&#xD;
&#xD;
          -  Patient has started immunotherapy or changed their dose of immunotherapy within 30&#xD;
             days of the first placebo lead-in dose or is likely to have to start immunotherapy, or&#xD;
             change their current dose during the study.&#xD;
&#xD;
          -  Treatment for oral Candidiasis within 30 days of starting the study or a current oral&#xD;
             Candidiasis infection.&#xD;
&#xD;
          -  Upper respiratory tract infection within the previous 30 days.&#xD;
&#xD;
          -  Patients with a history of tuberculosis.&#xD;
&#xD;
          -  Patients with presence of glaucoma, cataracts, ocular herpes simplex, conjunctivitis,&#xD;
             or other eye infection not related to the diagnosis of SAR within 14 days of&#xD;
             enrollment.&#xD;
&#xD;
          -  The patient has had recent exposure (30 days) or was at risk of being exposed to&#xD;
             chicken pox or measles.&#xD;
&#xD;
          -  Patients with any untreated fungal, bacterial, or systemic viral infections within the&#xD;
             previous 30 days.&#xD;
&#xD;
          -  Use of any ophthalmic steroids within 14 days or nasal, inhaled, or systemic steroids&#xD;
             within 30 days of the study start. Super or high potency topical steroids should not&#xD;
             be used during the study.&#xD;
&#xD;
          -  Use of medications that significantly inhibit the cytochrome P450 subfamily enzyme&#xD;
             CYP3A4.&#xD;
&#xD;
          -  Use of intranasal or systemic second-generation anti-histamines within 10 days or&#xD;
             enrollment.&#xD;
&#xD;
          -  Use of intranasal cromolyn within 14 days of enrollment.&#xD;
&#xD;
          -  Use of intranasal or systemic first-generation anti-histamines, leukotriene receptor&#xD;
             antagonsits or other nasal decongestants within 3 days of enrollment.&#xD;
&#xD;
          -  Use of any tricyclic anti-depressant within 30 days of enrollment.&#xD;
&#xD;
          -  Patients with attention-deficit disorder being treated with methylphenidate containing&#xD;
             products that have not been on a stable regimen for at least the 30 previous days and&#xD;
             who cannot remain of the same dose throughout the study.&#xD;
&#xD;
          -  Desensitization therapy to the seasonal allergen that is causing the patient's&#xD;
             allergic rhinitis within the previous 6 months.&#xD;
&#xD;
          -  Previous SAR and/or PAR that has proven unresponsive to steroid therapy.&#xD;
&#xD;
          -  Any known hypersensitivity to azelastine hydrochloride, fluticasone propionate, other&#xD;
             steroids, or any components of the study nasal spray.&#xD;
&#xD;
          -  Significant history or current evidence of chronic infectious disease, system&#xD;
             disorder, organ disorder, or other medical condition that in the Investigator's&#xD;
             opinion would place the patient at undue risk by participating or could jeopardize the&#xD;
             integrity of the study evaluations.&#xD;
&#xD;
          -  Receipt of any drug as part of a research study within 30 days prior to the first&#xD;
             placebo lead-in dose.&#xD;
&#xD;
          -  Planned travel outside of the local area for more than 2 consecutive days or 3 days in&#xD;
             total, during the patient's participation in the study.&#xD;
&#xD;
          -  Previous participation in this study.&#xD;
&#xD;
          -  The patient has a history of non-compliance with medication regimens or treatment&#xD;
             protocols in previous clinical studies.&#xD;
&#xD;
          -  The patient is a member of the investigational study staff or a member of the family&#xD;
             of the investigational study staff.&#xD;
&#xD;
          -  The patient currently smokes cigarettes, cigars, and/or pipes and is a heavy smoker&#xD;
             (for example, on average more than 10 cigarettes per day).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Darin Brimhall, DO, FACP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Novum Pharmaceutical Research Services</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Darin Brimhall, DO, FACP</last_name>
    <phone>(702) 435-3739</phone>
    <phone_ext>370</phone_ext>
    <email>dbrimhall@novumprs.som</email>
  </overall_contact>
  <location>
    <facility>
      <name>Novum Pharmaceutical Research Services</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15206</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gail Gongas</last_name>
      <phone>412-363-3300</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>September 22, 2014</last_update_submitted>
  <last_update_submitted_qc>September 22, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bioequivalence</keyword>
  <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>
  <pending_results>
    <submitted>January 6, 2020</submitted>
    <returned>January 13, 2020</returned>
    <submitted>October 6, 2020</submitted>
    <returned>October 27, 2020</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02249663
org study id: 71336006
nct id: NCT02249663
lead sponsor: 
To evaluate the therapeutic equivalence of a test formulation of Azelastine hydrochloride and
      Fluticasone propionate Nasal Spray to the reference listed drug, Dymista™ Nasal Spray in the
      relief of the signs and symptoms of Seasonal Allergic Rhinitis.
allocation: Randomized
intervention model: Parallel Assignment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change from baseline in average AM/PM reflective Total Nasal Symptom Score (rTNSS).
time frame: Days 1 to 14
measure: Change from baseline in average instantaneous Total Nasal Symptom Score (iTNSS).
time frame: Days 1 to 14
measure: Change from baseline in average reflective Total Ocular Symptom Score (iTOSS).
time frame: Days 1 to 14
measure: Change from baseline in average instantaneous Total Ocular Symptom Score (iTOSS).
time frame: Days 1 to 14
measure: Onset of Action
time frame: 4 hours post dose
arm group label: Investigational Test Product
arm group type: Experimental
description: Azelastine hydrochloride and Fluticasone propionate Nasal Spray, 137/50 mcg
arm group label: Reference Listed Drug
arm group type: Active Comparator
description: Dymista™ (azelastine hydrochloride/fluticasone propionate) Nasal Spray, 137/50 mcg
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo Nasal Spray
intervention type: Drug
intervention name: Azelastine hydrochloride and Fluticasone propionate
description: 137/50 mcg Nasal Spray
arm group label: Investigational Test Product
intervention type: Drug
intervention name: Dymista™
description: 137/50 mcg Nasal Spray
arm group label: Reference Listed Drug
other name: Azelastine hydrochloride and Fluticasone propionate (generic name)
intervention type: Other
intervention name: Placebo
description: Nasal spray with no pharmaceutically active content
arm group label: Placebo
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
last name: Darin Brimhall, DO, FACP
role: Principal Investigator
affiliation: Novum Pharmaceutical Research Services
last name: Darin Brimhall, DO, FACP
phone: (702) 435-3739
phone ext: 370
email: dbrimhall@novumprs.som
facility: 
status: Recruiting
contact: 
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
submitted: January 6, 2020
returned: January 13, 2020
submitted: October 6, 2020
returned: October 27, 2020