<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/NCT03028350</url>
  </required_header>
  <id_info>
    <org_study_id>CPI-IFE-006</org_study_id>
    <nct_id>NCT03028350</nct_id>
  </id_info>
  <brief_title>Oral Ifetroban to Treat Aspirin Exacerbated Respiratory Disease (AERD)</brief_title>
  <official_title>A Phase 2 Multicenter, Double-blind, Randomized, Placebo-Controlled Trial to Evaluate Oral Ifetroban in Subjects With Symptomatic Aspirin Exacerbated Respiratory Disease (AERD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cumberland Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cumberland Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this phase 2 study is to assess the safety and efficacy of oral ifetroban for&#xD;
      the treatment of aspirin-exacerbated respiratory disease (AERD). AERD is a disease that&#xD;
      involves asthma, recurring nasal polyps, and respiratory reactions to aspirin and other&#xD;
      nonsteroidal anti-inflammatory drugs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, placebo-controlled, double-blind phase 2 trial evaluating approximately&#xD;
      76 subjects with symptomatic AERD on the safety and efficacy of 8 weeks of oral ifetroban&#xD;
      treatment. Eligible AERD subjects will be randomized to receive 8 weeks of either oral&#xD;
      ifetroban daily or matching placebo followed by a 2-week post-treatment period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 17, 2017</start_date>
  <completion_date type="Anticipated">August 2024</completion_date>
  <primary_completion_date type="Anticipated">April 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 From Baseline in Sino-Nasal Outcome Test-22 score</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Asthma Control Questionnaire -7 score</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Total Nasal Symptom score</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in FEV1</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in PNIFR</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in FeNO</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in rescue medication</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in antibiotic use</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Change From Baseline in blood, urine and nasal epithelial biomarkers</measure>
    <time_frame>8 weeks</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">76</enrollment>
  <condition>Asthma, Aspirin-Induced</condition>
  <arm_group>
    <arm_group_label>Ifetroban Oral Capsule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral ifetroban, 200 mg daily for 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Oral Capsule</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Oral placebo daily for 8 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ifetroban Oral Capsule</intervention_name>
    <description>Subjects will be treated with oral ifetroban daily for 8 weeks</description>
    <arm_group_label>Ifetroban Oral Capsule</arm_group_label>
    <other_name>Ifetroban</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Capsule</intervention_name>
    <description>Subjects will be treated with oral placebo daily for 8 weeks</description>
    <arm_group_label>Placebo Oral Capsule</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. History of physician-diagnosed asthma&#xD;
&#xD;
          2. History of nasal polyposis&#xD;
&#xD;
          3. History of at least two reactions to oral aspirin or other nonselective cyclooxygenase&#xD;
             inhibitor with features of lower airway involvement (cough, chest tightness, wheezing,&#xD;
             dyspnea), or one reaction that was life-threatening and required hospitalization, or a&#xD;
             diagnosis of AERD by a physician-conducted challenge to aspirin in the last five years&#xD;
             before starting treatment.&#xD;
&#xD;
          4. Stable asthma (post-bronchodilator FEV1 of ≥ 60%, no glucocorticoid burst for at least&#xD;
             two weeks prior to starting treatment, no hospitalizations or emergency room visits&#xD;
             for asthma at least three months prior to starting treatment and not on a dose &gt;1000&#xD;
             µg fluticasone or equivalent daily).&#xD;
&#xD;
          5. ≥ 18 years of age&#xD;
&#xD;
          6. Exhibit symptomatic AERD within three weeks of starting treatment by demonstrating a&#xD;
             score of at least 20 on the Sino-nasal Outcome Test (SNOT) - 22.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current smoking, defined as daily tobacco smoking in the last six months and at least&#xD;
             one instance of tobacco smoking in the last three months.&#xD;
&#xD;
          2. Current pregnancy or breastfeeding&#xD;
&#xD;
          3. Use of oral or systemic steroids (e.g. prednisone or equivalent) &gt; 20 mg daily in the&#xD;
             last four weeks before starting treatment.&#xD;
&#xD;
          4. Daily use of long-acting antihistamines in the last two weeks before starting&#xD;
             treatment.&#xD;
&#xD;
          5. Less than 12 months of allergy shots (maintenance dose of allergy shots are allowed if&#xD;
             treatment duration exceeds 12 months). Less than 1 month of 5-lipoxygenase inhibitors&#xD;
             (e.g. zileuton) and/or leukotriene receptor antagonists (e.g. montelukast).&#xD;
&#xD;
          6. Any use of nonsteroidal anti-inflammatory drugs (NSAIDs) or any drug that inhibits the&#xD;
             cyclooxygenase enzyme in the last two weeks before starting treatment.&#xD;
&#xD;
          7. History of bleeding diathesis or use of anticoagulant or antiplatelet drugs in the&#xD;
             last two weeks before starting treatment.&#xD;
&#xD;
          8. Any immunosuppressive treatment including but not limited to methotrexate,&#xD;
             cyclosporine, mycophenolate, tacrolimus, gold, penicillamine, sulfasalazine,&#xD;
             hydroxychloroquine, azathioprine, and cyclophosphamide in the last two weeks before&#xD;
             starting treatment (maintenance dose of allergy shots are allowed if treatment&#xD;
             duration exceeds 12 months). Biologics/immunotherapies such as Xolair or Nucala are&#xD;
             permitted if duration exceeds three months.&#xD;
&#xD;
          9. Endoscopic sinus surgery / polypectomy within the past three months&#xD;
&#xD;
         10. Previously treated in a clinical trial with ifetroban within the past three months.&#xD;
&#xD;
         11. Previously treated with other investigational drugs within eight weeks or five&#xD;
             half-lives, whichever is longer, before screening&#xD;
&#xD;
         12. Conditions/concomitant disease which make them unevaluable for the efficacy endpoints&#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>Andrew White, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Scripps Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Banner University of Arizona Medical Center, Asthma &amp; Airway Disease Research Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Antelope Valley Clinical Trials</name>
      <address>
        <city>Lancaster</city>
        <state>California</state>
        <zip>93534</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scripps Clinic - Carmel Valley</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford University Medical Center</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Research Center</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33013</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University School of Medicine, Sinus, Nasal, and Allergy Center</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Deaconess Clinic</name>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <zip>47713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kansas City Allergy and Asthma Associates, PA</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced ENT &amp; Allergy</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rochester Regional Health</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest Baptist Health</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390-9035</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia Medical Center</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>August 1, 2023</last_update_submitted>
  <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2023</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>Respiratory Tract Diseases</mesh_term>
    <mesh_term>Respiration Disorders</mesh_term>
    <mesh_term>Asthma, Aspirin-Induced</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ifetroban</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03028350
org study id: CPI-IFE-006
nct id: NCT03028350
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this phase 2 study is to assess the safety and efficacy of oral ifetroban for
      the treatment of aspirin-exacerbated respiratory disease (AERD). AERD is a disease that
      involves asthma, recurring nasal polyps, and respiratory reactions to aspirin and other
      nonsteroidal anti-inflammatory drugs.
This is a randomized, placebo-controlled, double-blind phase 2 trial evaluating approximately
      76 subjects with symptomatic AERD on the safety and efficacy of 8 weeks of oral ifetroban
      treatment. Eligible AERD subjects will be randomized to receive 8 weeks of either oral
      ifetroban daily or matching placebo followed by a 2-week post-treatment period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change From Baseline in Sino-Nasal Outcome Test-22 score
time frame: 8 weeks
measure: Change From Baseline in Asthma Control Questionnaire -7 score
time frame: 8 weeks
measure: Change From Baseline in Total Nasal Symptom score
time frame: 8 weeks
measure: Change From Baseline in FEV1
time frame: 8 weeks
measure: Change From Baseline in PNIFR
time frame: 8 weeks
measure: Change From Baseline in FeNO
time frame: 8 weeks
measure: Change From Baseline in rescue medication
time frame: 8 weeks
measure: Change From Baseline in antibiotic use
time frame: 8 weeks
measure: Change From Baseline in blood, urine and nasal epithelial biomarkers
time frame: 8 weeks
arm group label: Ifetroban Oral Capsule
arm group type: Experimental
description: Oral ifetroban, 200 mg daily for 8 weeks
arm group label: Placebo Oral Capsule
arm group type: Placebo Comparator
description: Oral placebo daily for 8 weeks
intervention type: Drug
intervention name: Ifetroban Oral Capsule
description: Subjects will be treated with oral ifetroban daily for 8 weeks
arm group label: Ifetroban Oral Capsule
other name: Ifetroban
intervention type: Drug
intervention name: Placebo Oral Capsule
description: Subjects will be treated with oral placebo daily for 8 weeks
arm group label: Placebo Oral Capsule
other name: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrew White, MD
role: Principal Investigator
affiliation: Scripps Research Institute
facility: 
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Respiratory Tract Diseases
mesh term: Respiration Disorders
mesh term: Asthma, Aspirin-Induced
mesh term: Ifetroban
sharing ipd: No