<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/NCT02967731</url>
  </required_header>
  <id_info>
    <org_study_id>480MFSDD2016-001</org_study_id>
    <nct_id>NCT02967731</nct_id>
  </id_info>
  <brief_title>480 Biomedical Sinus Drug Depot</brief_title>
  <official_title>An Exploratory Safety Study of 480 Biomedical Sinus Drug Depot in Adult Subjects With Chronic Sinusitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lyra Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lyra Therapeutics</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 is a Phase I, exploratory safety study of the 480 Biomedical Mometasone Furoate Sinus&#xD;
      Drug Depot in adult subjects with chronic sinusitis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 6, 2017</start_date>
  <completion_date type="Actual">May 18, 2018</completion_date>
  <primary_completion_date type="Actual">December 19, 2017</primary_completion_date>
  <phase>Phase 1</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>Product related serious adverse events from baseline visit to 4 weeks post procedure</measure>
    <time_frame>4 weeks post procedure</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma Mometasone Furoate concentration level from pre-treatment to end of treatment</measure>
    <time_frame>Up to 24 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Chronic Sinusitis</condition>
  <arm_group>
    <arm_group_label>480 Mometasone Furoate Sinus Drug Depot</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>480 Mometasone Furoate Sinus Drug Depot</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>480 Mometasone Furoate Sinus Drug Depot</intervention_name>
    <description>Management of Chronic Sinusitis</description>
    <arm_group_label>480 Mometasone Furoate Sinus Drug Depot</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of CS.&#xD;
&#xD;
          -  Female study subjects of child-bearing potential must have a negative pregnancy test&#xD;
             and must agree to not become pregnant during the course of the study.&#xD;
&#xD;
          -  The study subject has been informed of the nature of the study, agrees to its&#xD;
             provisions and has provided written informed consent as approved by the ethics&#xD;
             committee of the respective clinical site.&#xD;
&#xD;
          -  The study subject agrees to comply with all study requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known history of intolerance to corticosteroids.&#xD;
&#xD;
          -  Oral-steroid dependent condition.&#xD;
&#xD;
          -  Having had corticosteroids with potential systemic effect (e.g., oral, parenteral, or&#xD;
             high dose topical) 1 month prior to screening visit.&#xD;
&#xD;
          -  Subjects with acute or chronic intracranial or orbital complications of chronic&#xD;
             rhinosinusitis (e.g., brain abscess, related problems with eyes or central nervous&#xD;
             system).&#xD;
&#xD;
          -  Known history of hypothalamic pituitary adrenal (HPA) axial dysfunction or having&#xD;
             morning serum cortisol level at screening outside of normal range.&#xD;
&#xD;
          -  Previous pituitary or adrenal surgery.&#xD;
&#xD;
          -  History or diagnosis (in either eye) of glaucoma, ocular hypertension, or cataracts.&#xD;
&#xD;
          -  Recent participation in another clinical trial within 1 month of screening visit.&#xD;
&#xD;
          -  Subjects currently participating in an investigational drug or device study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Queen Elizabeth Hospital</name>
      <address>
        <city>Adelaide</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Brisbane and Women's Hospital</name>
      <address>
        <city>Brisbane</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monash Medical Center</name>
      <address>
        <city>Melbourne</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Auckland</name>
      <address>
        <city>Auckland</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>New Zealand</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>August 20, 2021</last_update_submitted>
  <last_update_submitted_qc>August 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 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>Sinusitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mometasone Furoate</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/NCT02967731
org study id: 480MFSDD2016-001
nct id: NCT02967731
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a Phase I, exploratory safety study of the 480 Biomedical Mometasone Furoate Sinus
      Drug Depot in adult subjects with chronic sinusitis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Product related serious adverse events from baseline visit to 4 weeks post procedure
time frame: 4 weeks post procedure
measure: Plasma Mometasone Furoate concentration level from pre-treatment to end of treatment
time frame: Up to 24 weeks
arm group label: 480 Mometasone Furoate Sinus Drug Depot
arm group type: Experimental
description: 480 Mometasone Furoate Sinus Drug Depot
intervention type: Drug
intervention name: 480 Mometasone Furoate Sinus Drug Depot
description: Management of Chronic Sinusitis
arm group label: 480 Mometasone Furoate Sinus Drug Depot
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: Australia
country: New Zealand
responsible party type: Sponsor
mesh term: Sinusitis
mesh term: Mometasone Furoate