<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/NCT03772405</url>
  </required_header>
  <id_info>
    <org_study_id>18-05 NAPO</org_study_id>
    <nct_id>NCT03772405</nct_id>
  </id_info>
  <brief_title>Effect of the Nasal Gel &quot;Nascum®-Plus&quot; on Allergic Symptoms</brief_title>
  <acronym>NAPO</acronym>
  <official_title>Cross Over Study to Assess the Effect of the Nasal Gel &quot;Nascum®-Plus&quot; on Allergic Symptoms and Inflammatory Cells and Cytokines During and After Allergen Challenge in the Fraunhofer Allergen Challenge Chamber (ACC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fraunhofer-Institute of Toxicology and Experimental Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>M et P Pharma AG</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fraunhofer-Institute of Toxicology and Experimental Medicine</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>
      The aim of this study is to assess if a physical barrier, created by the nasal gel Nascum®-&#xD;
      Plus, is able to prevent or minimize the induction of nasal symptoms during allergen&#xD;
      challenge in the Fraunhofer Allergen Challenge Chamber (ACC). Furthermore, the effect on&#xD;
      soluble and cellular inflammatory markers induced by the allergic reaction will be assessed.&#xD;
      Nascum®-Plus contains no active pharmaceutical ingredient, only monographed pharmaceutical&#xD;
      excipients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 12, 2018</start_date>
  <completion_date type="Actual">February 1, 2019</completion_date>
  <primary_completion_date type="Actual">February 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total Nasal Symptom Score (TNSS)</measure>
    <time_frame>pre start of challenge and every 20 minutes during 4 hours challenge</time_frame>
    <description>Change of TNSS assessed during grass pollen challenge in ACC</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Rhinitis, Allergic, Seasonal</condition>
  <arm_group>
    <arm_group_label>Nascum Plus and ACC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In a cross-over design, patients are exposed to pollen in the ACC twice for 4 hours each 3 weeks apart. Subjects will receive treatment with Nascum Plus either 5 minutes before the first or the second 4 hour pollen challenge.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nascum Plus</intervention_name>
    <description>nasal application of nascum plus</description>
    <arm_group_label>Nascum Plus and ACC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ACC</intervention_name>
    <description>4 hours challenge to grass pollen in the allergen challenge chamber (ACC)</description>
    <arm_group_label>Nascum Plus and ACC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Able and willing to give written informed consent.&#xD;
&#xD;
          -  2. Male and female subjects, aged 18-65 years. Women will be considered for inclusion&#xD;
             if they are: Not pregnant, as confirmed by pregnancy test (see flow chart), and not&#xD;
             nursing. Of non-child bearing potential (i.e. physiologically incapable of becoming&#xD;
             pregnant, including any female who is pre-menarchial or post-menopausal, with&#xD;
             documented proof of hysterectomy or tubal ligation, or meets clinical criteria for&#xD;
             menopause and has been amenorrhoeic for more than 1 year prior to the screening&#xD;
             visit).&#xD;
&#xD;
        Of childbearing potential and using a highly effective method of contraception during the&#xD;
        entire study (vasectomised partner, sexual abstinence - the lifestyle of the female should&#xD;
        be such that there is complete abstinence from intercourse from two weeks prior to the&#xD;
        first dose of study medication until at least 72 hours after treatment -, implants,&#xD;
        injectables, combined oral contraceptives, hormonal IUDs or double-barrier methods, i.e.&#xD;
        any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical&#xD;
        cap).&#xD;
&#xD;
          -  3. Body mass index between 18 and 32 kg/m²&#xD;
&#xD;
          -  4. History of seasonal allergic rhinitis to grass pollen&#xD;
&#xD;
          -  5. Positive skin prick test for Dactylis glomerata pollen at screening or within 12&#xD;
             months prior to the screening visit.&#xD;
&#xD;
          -  6. Normal lung function Forced Expiratory Volume in one second (FEV1) ≥ 80 % pred and&#xD;
             FEV1/Forced Vital Capacity (FVC) &gt;70% at screening&#xD;
&#xD;
          -  7. Adequate level of rhinitis symptoms in a grass pollen challenge, defined as a Total&#xD;
             Nasal Symptom Score (TNSS) of at least 6 (of 12) within the 2-hour grass pollen&#xD;
             challenge at performed at the Screening ACC visit (V2).&#xD;
&#xD;
          -  8. TNSS of 3 prior to entering the pollen chamber at screening.&#xD;
&#xD;
          -  9. Non-smokers or ex-smokers since at least 6 months with a history of less than 10&#xD;
             pack years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Any clinically relevant abnormal findings in physical examination, clinical&#xD;
             chemistry, hematology, urine analysis, vital signs, lung function or Electrocardiogram&#xD;
             (ECG) at screening visit , which, in the opinion of the investigator, may either put&#xD;
             the subject at risk because of participation in the study or may influence the results&#xD;
             of the study, or the subject's ability to participate in the study&#xD;
&#xD;
          -  2. Past or present disease, which as judged by the investigator, may affect the&#xD;
             outcome of this study. These diseases include, but are not limited to, cardiovascular&#xD;
             disease, malignancy, hepatic disease, renal disease, hematological disease,&#xD;
             neurological disease, endocrine disease or pulmonary disease (including but not&#xD;
             confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic&#xD;
             fibrosis).&#xD;
&#xD;
          -  3. History of an acute infection four weeks prior to the informed consent visit&#xD;
&#xD;
          -  4. Specific Immunotherapy (SIT) within 2 years prior to the study&#xD;
&#xD;
          -  5. Rhinitis of other cause, chronic sinusitis or rhinitis or sinusitis in the last 14&#xD;
             days before entering the study&#xD;
&#xD;
          -  6. Asthma requiring more than inhaled short-acting beta-2 agonists.&#xD;
&#xD;
          -  7. Conditions or factors, which would make the subject unlikely to be able to stay in&#xD;
             the Fraunhofer ACC for 4 hours.&#xD;
&#xD;
          -  8. Any contraindication for adrenalin use (e.g. use of local and systemic&#xD;
             beta-blockers, angiotensin-converting-enzyme (ACE) inhibitors&#xD;
&#xD;
          -  9. Treatment with antipsychotic medications with antihistaminic effect (e.g.&#xD;
             chlorpromazine, levomepromazine, clozapine, olanzapine, tioridazine)&#xD;
&#xD;
          -  10. Use of any medications according to section 8.2 in the period indicated before&#xD;
             allergen challenge&#xD;
&#xD;
          -  11. Participation in another clinical trial 30 days prior to enrollment.&#xD;
&#xD;
          -  12. History of drug or alcohol abuse&#xD;
&#xD;
          -  13. Risk of non-compliance with study procedures&#xD;
&#xD;
          -  14. Suspected inability to understand the protocol requirements, instructions and&#xD;
             study-related restrictions, the nature, scope, and possible consequences of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philipp Badorrek, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fraunhofer Gesellschaft</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fraunhofer ITEM</name>
      <address>
        <city>Hannover</city>
        <state>Niedersachsen</state>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>February 13, 2019</last_update_submitted>
  <last_update_submitted_qc>February 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fraunhofer-Institute of Toxicology and Experimental Medicine</investigator_affiliation>
    <investigator_full_name>Philipp Badorrek</investigator_full_name>
    <investigator_title>Head of Department, Principle Investigator</investigator_title>
  </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>
  <!-- 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/NCT03772405
org study id: 18-05 NAPO
nct id: NCT03772405
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to assess if a physical barrier, created by the nasal gel Nascum®-
      Plus, is able to prevent or minimize the induction of nasal symptoms during allergen
      challenge in the Fraunhofer Allergen Challenge Chamber (ACC). Furthermore, the effect on
      soluble and cellular inflammatory markers induced by the allergic reaction will be assessed.
      Nascum®-Plus contains no active pharmaceutical ingredient, only monographed pharmaceutical
      excipients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Total Nasal Symptom Score (TNSS)
time frame: pre start of challenge and every 20 minutes during 4 hours challenge
description: Change of TNSS assessed during grass pollen challenge in ACC
arm group label: Nascum Plus and ACC
arm group type: Experimental
description: In a cross-over design, patients are exposed to pollen in the ACC twice for 4 hours each 3 weeks apart. Subjects will receive treatment with Nascum Plus either 5 minutes before the first or the second 4 hour pollen challenge.
intervention type: Drug
intervention name: Nascum Plus
description: nasal application of nascum plus
arm group label: Nascum Plus and ACC
intervention type: Other
intervention name: ACC
description: 4 hours challenge to grass pollen in the allergen challenge chamber (ACC)
arm group label: Nascum Plus and ACC
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Philipp Badorrek, MD
role: Principal Investigator
affiliation: Fraunhofer Gesellschaft
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Fraunhofer-Institute of Toxicology and Experimental Medicine
investigator full name: Philipp Badorrek
investigator title: Head of Department, Principle Investigator
mesh term: Rhinitis
mesh term: Rhinitis, Allergic
mesh term: Rhinitis, Allergic, Seasonal