xml: <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/NCT05970731</url>
    </required_header>
    <id_info>
      <org_study_id>Pro00113299</org_study_id>
      <nct_id>NCT05970731</nct_id>
    </id_info>
    <brief_title>Directed Topical Drug Delivery for Treatment for PASC Hyposmia</brief_title>
    <official_title>Directed Topical Drug Delivery for Treatment for PASC Hyposmia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Duke University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Duke University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a phase II randomized, double-blinded, placebo-controlled study to evaluate the&#xD;
        efficacy of topical intranasal treatment of beclomethasone vs. placebo for improved olfactory&#xD;
        function.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Eligible participants are randomized to receive either Beclomethasone or placebo intranasally&#xD;
        via a microsponge twice on day 1 and day 14. Study duration is three months and includes 4&#xD;
        in-person study visits: 2 visits for drug administration at Baseline and Week 2, and 2&#xD;
        follow-up visits at Week 6 and Week 12. Participants will be expected to complete the Smell&#xD;
        Identification Test (SIT) and Questionnaire on Olfactory Disorders (QOD) at baseline, Week 6,&#xD;
        and Week 12. The investigator hypothesizes that the application of beclomethasone directly in&#xD;
        the nasal cavity will result in improved olfactory function.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">January 2024</completion_date>
    <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
    <phase>Phase 2</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in olfactory function as measured by the Smell Identification Test (SIT)</measure>
      <time_frame>Baseline, 6 weeks, 12 weeks</time_frame>
      <description>The SIT has a score range of 0 to 40, where a higher score reflects better olfactory function.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in olfactory quality of life (QOL) measured by the Questionnaire on Olfactory Disorders (QOD)</measure>
      <time_frame>Baseline, 6 weeks, 12 weeks</time_frame>
      <description>The QOD consists of 17 statements which patients report on a scale of 0 to 3. These scores are summed for a total score range of 0 to 51, where a higher score reflects better olfactory-specific QOL.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Post Acute Sequelae Covid-19 Hyposmia</condition>
    <arm_group>
      <arm_group_label>Beclomethasone</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>84 mcg of Beclomethasone administered twice in each nostril via a microsponge (Day 1 and Day 14)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo (0.9% sodium chloride) administered twice in each nostril via a microsponge (Day 1 and Day 14)</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Beclomethasone</intervention_name>
      <description>84 mcg of Beclomethasone administered topically on an intranasal microsponge, placed in the olfactory cleft using a nasal endoscope, on day 1 and repeated on day 14.</description>
      <arm_group_label>Beclomethasone</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo (0.9% sodium chloride) administered topically on an intranasal microsponge, placed in the olfactory cleft using a nasal endoscope, on day 1 and repeated on day 14.</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Microsponge</intervention_name>
      <description>Drug delivery using chitosan-based biocompatible microsponge</description>
      <arm_group_label>Beclomethasone</arm_group_label>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Post-COVID hyposmia lasting greater than 3 months following COVID19 by history&#xD;
  &#xD;
            -  Male or female, aged 18 years or older&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnancy or lactation&#xD;
  &#xD;
            -  Known allergic reactions to components of microsponge (including shellfish) or to&#xD;
               beclomethasone&#xD;
  &#xD;
            -  Known diagnosis of glaucoma&#xD;
  &#xD;
            -  Febrile illness within 1 week&#xD;
  &#xD;
            -  Treatment with another investigational drug or other intervention within 3 months&#xD;
  &#xD;
            -  Active sinonasal disease by nasal exam, i.e. rhinosinusitis, nasal polyps&#xD;
  &#xD;
            -  Adults unable to consent&#xD;
  &#xD;
            -  Prisoners, employees or subordinates&#xD;
  &#xD;
            -  Individuals who are not yet adults (infants, children, teenagers)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Bradley Goldstein, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Duke Health</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Eliza Sorrell</last_name>
      <phone>+1 919 684 6484</phone>
      <email>eliza.sorrell@duke.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Amy Walker</last_name>
      <phone>+1 919 684 1732</phone>
      <email>amy.walker1@duke.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Duke University Medical Center</name>
        <address>
          <city>Durham</city>
          <state>North Carolina</state>
          <zip>27710</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Bradley Goldstein, MD, PhD</last_name>
        <phone>919-684-6595</phone>
        <email>bradley.goldstein@duke.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Covid-19</keyword>
    <keyword>smell loss</keyword>
    <keyword>hyposmia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>COVID-19</mesh_term>
      <mesh_term>Anosmia</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Beclomethasone</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05970731
  org study id: Pro00113299
  nct id: NCT05970731
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: Yes
  is us export: No
  This is a phase II randomized, double-blinded, placebo-controlled study to evaluate the
        efficacy of topical intranasal treatment of beclomethasone vs. placebo for improved olfactory
        function.
  Eligible participants are randomized to receive either Beclomethasone or placebo intranasally
        via a microsponge twice on day 1 and day 14. Study duration is three months and includes 4
        in-person study visits: 2 visits for drug administration at Baseline and Week 2, and 2
        follow-up visits at Week 6 and Week 12. Participants will be expected to complete the Smell
        Identification Test (SIT) and Questionnaire on Olfactory Disorders (QOD) at baseline, Week 6,
        and Week 12. The investigator hypothesizes that the application of beclomethasone directly in
        the nasal cavity will result in improved olfactory function.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Change in olfactory function as measured by the Smell Identification Test (SIT)
  time frame: Baseline, 6 weeks, 12 weeks
  description: The SIT has a score range of 0 to 40, where a higher score reflects better olfactory function.
  measure: Change in olfactory quality of life (QOL) measured by the Questionnaire on Olfactory Disorders (QOD)
  time frame: Baseline, 6 weeks, 12 weeks
  description: The QOD consists of 17 statements which patients report on a scale of 0 to 3. These scores are summed for a total score range of 0 to 51, where a higher score reflects better olfactory-specific QOL.
  arm group label: Beclomethasone
  arm group type: Active Comparator
  description: 84 mcg of Beclomethasone administered twice in each nostril via a microsponge (Day 1 and Day 14)
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Placebo (0.9% sodium chloride) administered twice in each nostril via a microsponge (Day 1 and Day 14)
  intervention type: Drug
  intervention name: Beclomethasone
  description: 84 mcg of Beclomethasone administered topically on an intranasal microsponge, placed in the olfactory cleft using a nasal endoscope, on day 1 and repeated on day 14.
  arm group label: Beclomethasone
  intervention type: Other
  intervention name: Placebo
  description: Placebo (0.9% sodium chloride) administered topically on an intranasal microsponge, placed in the olfactory cleft using a nasal endoscope, on day 1 and repeated on day 14.
  arm group label: Placebo
  intervention type: Device
  intervention name: Microsponge
  description: Drug delivery using chitosan-based biocompatible microsponge
  arm group label: Beclomethasone
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Bradley Goldstein, MD, PhD
  role: Principal Investigator
  affiliation: Duke Health
  last name: Eliza Sorrell
  phone: +1 919 684 6484
  email: eliza.sorrell@duke.edu
  last name: Amy Walker
  phone: +1 919 684 1732
  email: amy.walker1@duke.edu
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: COVID-19
  mesh term: Anosmia
  mesh term: Beclomethasone
  sharing ipd: No