<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/NCT03004131</url>
  </required_header>
  <id_info>
    <org_study_id>X-03065-3311</org_study_id>
    <nct_id>NCT03004131</nct_id>
  </id_info>
  <brief_title>MP-AzeFlu Allergen Chamber - Onset of Action Study</brief_title>
  <official_title>Clinical Trial to Assess Onset of Action of Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray Delivered in a Single Spray (MP-AzeFlu) in the Treatment of Allergen-Induced Allergic Rhinitis Symptoms in Comparison to Placebo and Free Combination of Fluticasone Propionate Nasal Spray and Oral Loratadine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MEDA Pharma GmbH &amp; Co. KG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Viatris Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to assess the onset of action of fixed drug combination of azelastine&#xD;
      hydrochloride and fluticasone propionate nasal spray (MP-AzeFlu) in treating the nasal&#xD;
      symptoms of seasonal allergic rhinitis (SAR) induced by an allergen challenge in an&#xD;
      Environmental Exposure Chamber (EEC).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 7, 2017</start_date>
  <completion_date type="Actual">March 29, 2017</completion_date>
  <primary_completion_date type="Actual">March 29, 2017</primary_completion_date>
  <phase>Phase 4</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total Nasal Symptom Score (TNSS); change from baseline over the last 4 hours of exposure in an Environmental Exposure Chamber (EEC)</measure>
    <time_frame>Onset of action (first significant difference to placebo) up to 4 hours.</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">82</enrollment>
  <condition>Seasonal Allergic Rhinitis</condition>
  <arm_group>
    <arm_group_label>fixed drug combination</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MP29-02 or MP-AzuFlu as fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray (Dymista) plus Placebo tablet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Nasal spray with no active dose plus Placebo tablet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>active control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>fluticasone propionate nasal spray (Flonase) plus loratadine 10 mg tablets (Claritin)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Azelastine hydrochloride + fluticasone propionate nasal spray</intervention_name>
    <arm_group_label>fixed drug combination</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>fluticasone propionate nasal spray + loratadine</intervention_name>
    <arm_group_label>active control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Provide written informed consent.&#xD;
&#xD;
          2. Male or female subjects (childbearing and non-childbearing potential, defined as&#xD;
             females with no menstruation for a minimum of 12 months prior to screening) aged 18 to&#xD;
             55 years (inclusive) at screening.&#xD;
&#xD;
          3. History of SAR to ragweed pollen for at least the previous 2 ragweed pollen seasons.&#xD;
&#xD;
          4. Positive skin prick test (SPT) response to ragweed pollen (allergen induced wheal&#xD;
             diameter at least 3 mm larger than the negative control). A test performed in the&#xD;
             previous 12 months may be used to qualify the subject.&#xD;
&#xD;
             To be eligible for Visit 2 EEC, a subject must additionally comply with the following&#xD;
             criteria:&#xD;
&#xD;
          5. Asymptomatic or with mild symptoms during the baseline recording of symptoms prior to&#xD;
             start of the screening EEC (Visit 2):&#xD;
&#xD;
             - TNSS ≤ 3/12 with the score for each symptom being less than 2.&#xD;
&#xD;
             To be eligible for Visit 3, a subject must additionally comply with the following&#xD;
             criteria during Visit 2 EEC:&#xD;
&#xD;
          6. Demonstrate adequate symptomology:&#xD;
&#xD;
             - TNSS ≥ 6/12 on at least two ePDAT™ time point assessments during hours 0-2 in the&#xD;
             EEC (Visit 2), with at least one occurring during the last two time points.&#xD;
             Additionally, subjects will be required to meet a score of at least 2/3 for runny nose&#xD;
             at least twice during hours 0-2 in the EEC, with at least one occurring during the&#xD;
             last two time points.&#xD;
&#xD;
             To be eligible for randomisation (Visit 3), a subject must additionally comply with&#xD;
             the following criteria:&#xD;
&#xD;
          7. Demonstrate adequate symptomology:&#xD;
&#xD;
               -  TNSS ≥ 6/12 on at least two ePDAT™ time point assessments during hours 0-2 in the&#xD;
                  EEC (Visit 3), with at least one occurring during the last two time points.&#xD;
                  Additionally, subjects will be required to meet a score of at least 2/3 for runny&#xD;
                  nose at least twice during hours 0-2 in the EEC, with at least one occurring&#xD;
                  during the last two time points.&#xD;
&#xD;
               -  No evidence of complete nasal blockage on either one or both sides on anterior&#xD;
                  rhinoscopy within 30 minutes prior to dosing.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Safety concerns:&#xD;
&#xD;
          1. History of allergic reaction to fluticasone propionate, azelastine hydrochloride,&#xD;
             loratadine, or one of the excipients of the study treatments (e.g. benzalkonium&#xD;
             chloride, phenylethyl alcohol, microcrystalline cellulose) or a component of the&#xD;
             container.&#xD;
&#xD;
          2. History of anaphylaxis, cardiovascular, pulmonary, hepatic, renal, gastrointestinal,&#xD;
             haematological, endocrine, metabolic, psychiatric, neurological, or other disease at&#xD;
             screening that may affect subject safety during the study or evaluation of the study&#xD;
             endpoints at the discretion of the Investigator and/or designee.&#xD;
&#xD;
          3. Subjects with a current diagnosis of asthma or subjects with measured FEV1 &lt;75% of the&#xD;
             predicted value.&#xD;
&#xD;
          4. Pregnant, breast-feeding or planning a pregnancy during the study and women of&#xD;
             childbearing potential not using adequate contraception. Women of childbearing&#xD;
             potential not abstinent or using a highly effective method of birth control defined as&#xD;
             those which result in a low failure rate (i.e. &lt;1% per year) when used consistently&#xD;
             and correctly such as implants, injectables, combined oral contraceptives, hormonal&#xD;
             IUDs, tubal ligation or vasectomised partner started at least 4 weeks prior to&#xD;
             screening.&#xD;
&#xD;
             Lack of suitability for the study:&#xD;
&#xD;
          5. Previous and concomitant treatments: use of prohibited therapies (Antihistaminic&#xD;
             agents,Theophylline, Cromolyn sodium, Corticosteroids, Decongestants, Immunotherapy,&#xD;
             Systemic antibiotics, any cytochrome P450 3A4 inhibiting or inducing drug [e.g.&#xD;
             ritonavir, ketoconazole, itraconazole, erythromycin, cimetidine, rifampicin, St.&#xD;
             John's wort (Hypericum perforatum) etc.], Tricyclic antidepressants and MAO inhibitors&#xD;
             ); and use of any medication considered to have an influence on the outcome of the&#xD;
             study during the EEC session, at the discretion of the Investigator and/or designee.&#xD;
&#xD;
          6. Subjects with (expected) clinically relevant symptoms at the timing of the scheduled&#xD;
             EEC assessments due to concomitant sensitization, i.e., positive SPT (mean wheal&#xD;
             diameter at least 3 mm larger than the negative control) and a history of allergic&#xD;
             response to the causative allergen, at the discretion of the Investigator. Subjects&#xD;
             with a positive SPT for cats and/or dogs are acceptable if the subject avoids cats&#xD;
             and/or dogs for the duration of the study.&#xD;
&#xD;
          7. Concomitant diseases: abnormalities during the screening visit that might interfere&#xD;
             with study results as determined by the Investigator and/or designee.&#xD;
&#xD;
          8. Presence of a severely deviated septum, septal perforation, structural nasal defect or&#xD;
             large nasal polyps causing obstruction as determined by the Investigator.&#xD;
&#xD;
          9. Acute conditions: any acute illness within 7 days prior to the screening visit,&#xD;
             including acute conjunctivitis or any other ocular infection.&#xD;
&#xD;
         10. History of increased ocular pressure, glaucoma and/or cataracts.&#xD;
&#xD;
         11. Tuberculosis, untreated local or systemic fungal or bacterial infections, systemic&#xD;
             viral or parasitic infections or ocular herpes simplex.&#xD;
&#xD;
         12. Recent nasal ulcers, mucosal erosion, nasal surgery, or nasal trauma, as judged by the&#xD;
             Investigator.&#xD;
&#xD;
         13. Exposure to chickenpox or measles within 4 weeks prior to the screening visit or&#xD;
             during the study.&#xD;
&#xD;
         14. History of chronic sinusitis or history of non-allergic rhinitis.&#xD;
&#xD;
         15. Exposure to another investigational product within the last 30 days prior to&#xD;
             screening.&#xD;
&#xD;
         16. History of malignancy within the past five years, except for basal cell skin&#xD;
             carcinomas that have been treated with no recurrence for at least 3 months.&#xD;
&#xD;
         17. Neurological or psychiatric disease or drug or alcohol abuse which would interfere&#xD;
             with the subject's proper completion of the protocol assignment. Subjects with a&#xD;
             positive urine drug screen will be excluded.&#xD;
&#xD;
         18. Subjects undergoing surgical procedures with general anaesthesia within 90 days prior&#xD;
             to screening or who plan to undergo surgery/hospitalization during the study.&#xD;
&#xD;
             Administrative reasons:&#xD;
&#xD;
         19. Vulnerable subjects (such as persons kept in detention).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christine Kolb</last_name>
    <role>Study Director</role>
    <affiliation>MEDA Pharma GmbH &amp; Co. KG</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Inflamax Research</name>
      <address>
        <city>Mississauga</city>
        <state>Ontario</state>
        <zip>L4W1Ae</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>February 4, 2022</last_update_submitted>
  <last_update_submitted_qc>February 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rhinitis</mesh_term>
    <mesh_term>Rhinitis, Allergic</mesh_term>
    <mesh_term>Rhinitis, Allergic, Seasonal</mesh_term>
  </condition_browse>
  <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>Loratadine</mesh_term>
    <mesh_term>Azelastine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03004131
org study id: X-03065-3311
nct id: NCT03004131
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is to assess the onset of action of fixed drug combination of azelastine
      hydrochloride and fluticasone propionate nasal spray (MP-AzeFlu) in treating the nasal
      symptoms of seasonal allergic rhinitis (SAR) induced by an allergen challenge in an
      Environmental Exposure Chamber (EEC).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Total Nasal Symptom Score (TNSS); change from baseline over the last 4 hours of exposure in an Environmental Exposure Chamber (EEC)
time frame: Onset of action (first significant difference to placebo) up to 4 hours.
arm group label: fixed drug combination
arm group type: Experimental
description: MP29-02 or MP-AzuFlu as fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray (Dymista) plus Placebo tablet
arm group label: Placebo
arm group type: Placebo Comparator
description: Nasal spray with no active dose plus Placebo tablet
arm group label: active control
arm group type: Active Comparator
description: fluticasone propionate nasal spray (Flonase) plus loratadine 10 mg tablets (Claritin)
intervention type: Drug
intervention name: Azelastine hydrochloride + fluticasone propionate nasal spray
arm group label: fixed drug combination
intervention type: Drug
intervention name: Placebos
arm group label: Placebo
intervention type: Drug
intervention name: fluticasone propionate nasal spray + loratadine
arm group label: active control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Christine Kolb
role: Study Director
affiliation: MEDA Pharma GmbH & Co. KG
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Rhinitis
mesh term: Rhinitis, Allergic
mesh term: Rhinitis, Allergic, Seasonal
mesh term: Fluticasone
mesh term: Xhance
mesh term: Loratadine
mesh term: Azelastine