<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/NCT02216357</url>
  </required_header>
  <id_info>
    <org_study_id>CPI-IFE-003</org_study_id>
    <nct_id>NCT02216357</nct_id>
  </id_info>
  <brief_title>Trial to Determine the Safety of Oral Ifetroban in Patients With a History of Aspirin Exacerbated Respiratory Disease</brief_title>
  <official_title>A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial to Determine the Safety of Oral Ifetroban in Patients With a History of Aspirin Exacerbated Respiratory Disease</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the study is to determine the safety of oral ifetroban compared to&#xD;
      placebo as measured by a &gt; 20% decrease in FEV1 compared to baseline following a dose of&#xD;
      Investigational Medicinal Product (IMP) (Study Day 1 or 2) prior to initiation of the aspirin&#xD;
      challenge.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</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>Proportion of Patients Who Experience a ≥ 20% Decrease in Forced Expiratory Volume in One Second (FEV1) Compared to Baseline Following a Dose of Investigational Medicinal Product (IMP) (Study Day 1 or 2) Prior to Initiation of the Aspirin Challenge</measure>
    <time_frame>Study Day 2</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients With a ≥ 25% Decrease in Peak Nasal Inspiratory Flow Rate Compared to Baseline Following a Dose of IMP (Study Day 1 or 2) Prior to Initiation of the Aspirin Challenge</measure>
    <time_frame>Up to Study Day 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients With a ≥ 25% Increase in Total Nasal Symptom Score (TNSS) Compared to Baseline Following a Dose of IMP (Study Day 1 or 2) Prior to Initiation of the Aspirin Challenge</measure>
    <time_frame>Up to Study Day 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence and Severity of Treatment-emergent Adverse Events</measure>
    <time_frame>Up to Study Day 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients Who Experience a ≥ 20% Decrease in FEV1 Compared to Baseline During the Aspirin Challenge</measure>
    <time_frame>Study Day 2 and 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients With a ≥ 25% Decrease in Peak Nasal Inspiratory Flow Rate (NIFR) Compared to Baseline During the Aspirin Challenge</measure>
    <time_frame>Study Day 2 and 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients With a ≥ 25% Increase in TNSS Compared to Baseline During the Aspirin Challenge</measure>
    <time_frame>Study Day 2 and 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of Rescue Medication Required During the Aspirin Challenge</measure>
    <time_frame>Study Day 2 and 3</time_frame>
    <description>The amount of rescue medication required during the aspirin challenge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence and Severity of Asthmatic Reactions During the Treatment Period</measure>
    <time_frame>Study Day 1 through 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients With an Aspirin Desensitization Dose Level of 30 mg, 60 mg, 100 mg, 150 mg, and 325 mg.</measure>
    <time_frame>Study Day 2 and 3</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Aspirin Exacerbated Respiratory Disease (AERD)</condition>
  <arm_group>
    <arm_group_label>Ifetroban, Oral Capsule</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo, Oral Capsule</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ifetroban, Oral Capsule</intervention_name>
    <arm_group_label>Ifetroban, Oral Capsule</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo, Oral Capsule</intervention_name>
    <arm_group_label>Placebo, Oral Capsule</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adults with a history of physician-diagnosed stable asthma (FEV1 of at least 1.25&#xD;
             liters and 60% or better than predicted* on two previous visits with no more than a&#xD;
             10% variation in those values, no increase in baseline dose of oral glucocorticoids&#xD;
             for asthma for at least three months, and no history of hospitalization or emergency&#xD;
             room visits for asthma for at least the prior six months).&#xD;
&#xD;
          2. Have a history of nasal polyposis.&#xD;
&#xD;
          3. Have a history of at least one clinical reaction to oral aspirin or other nonselective&#xD;
             cyclooxygenase (COX) inhibitor with features of lower (cough, chest tightness,&#xD;
             wheezing, dyspnea) and/or upper (rhinorrhea, sneezing, nasal obstruction, conjunctival&#xD;
             itching and discharge) airway involvement.&#xD;
&#xD;
          4. Currently receiving montelukast (at least 10 mg per day, oral) or Zafirlukast (at&#xD;
             least 20 mg twice per day, oral), with at least 1 week of therapy prior to first dose&#xD;
             of IMP.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Be less than 18 years of age or greater than or equal to 65 years of age.&#xD;
&#xD;
          2. Be pregnant, nursing, or planning to become pregnant.&#xD;
&#xD;
          3. Be a current tobacco smoker (defined as a daily tobacco smoker during any of the six&#xD;
             months preceding this study or more than one instance of tobacco smoking in the last&#xD;
             three months).&#xD;
&#xD;
          4. Use of a beta blocker in the last week.&#xD;
&#xD;
          5. Use of an antihistamine in the 48 hours prior to the first dose of IMP.&#xD;
&#xD;
          6. Use of nasal decongestants in the 48 hours prior to the first dose of IMP.&#xD;
&#xD;
          7. Use of aspirin or non-steroidal inflammatory drug (NSAID) in the last two weeks.&#xD;
&#xD;
          8. Use of zileuton in the last two weeks.&#xD;
&#xD;
          9. Have required one or more doses of ≥ 40 mg prednisone or equivalent in the last two&#xD;
             weeks.&#xD;
&#xD;
         10. Have a history of systemic or life-threatening respiratory reaction to aspirin&#xD;
             requiring intubation or administration of epinephrine.&#xD;
&#xD;
         11. Have a history of peptic ulcer disease, gastrointestinal bleed, or current severe&#xD;
             gastro-esophageal reflux disease (GERD), defined as a patient currently requiring more&#xD;
             than two total doses of medication per day to treat persistent symptoms: either more&#xD;
             than two doses of any single medication type (antacid, proton pump inhibitor, or H2&#xD;
             receptor antagonist), or more than 2 types of medication per day to treat symptoms.&#xD;
&#xD;
         12. Have a history of tolerating a COX-1 blocking drug after their history of a&#xD;
             respiratory reaction to a similar drug.&#xD;
&#xD;
         13. Have a history of cardiovascular disease including myocardial infarction, heart&#xD;
             failure, atrial or ventricular rhythm disturbances, or angina, or a previous abnormal&#xD;
             electrocardiogram.&#xD;
&#xD;
         14. Have a history of bleeding diathesis or use of anticoagulant or antiplatelet drugs in&#xD;
             the last two weeks.&#xD;
&#xD;
         15. Have a history of allergy or hypersensitivity to ifetroban.&#xD;
&#xD;
         16. Have taken investigational drugs within 30 days before IMP administration.&#xD;
&#xD;
         17. Inability to understand the requirements of the study, inability to understand spoken&#xD;
             English and abide by the study restrictions and to return for the required treatments&#xD;
             and assessments.&#xD;
&#xD;
         18. Be otherwise unsuitable for the study, in the opinion of the investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Scripps Clinic</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>32130</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>Allergy &amp; Asthma Consultants of Rockland &amp; Bergen</name>
      <address>
        <city>West Nyack</city>
        <state>New York</state>
        <zip>10994</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <results_first_submitted>February 2, 2017</results_first_submitted>
  <results_first_submitted_qc>February 2, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">March 22, 2017</results_first_posted>
  <last_update_submitted>April 9, 2017</last_update_submitted>
  <last_update_submitted_qc>April 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Samster's triad</keyword>
  <keyword>Acetylsalicylic acid triad</keyword>
  <keyword>Widal's triad</keyword>
  <keyword>Francis' triad</keyword>
  <keyword>Aspirin triad</keyword>
  <keyword>Aspirin-induced asthma and rhinitis (AIAR)</keyword>
  <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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ifetroban</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Ifetroban, Oral Capsule</title>
          <description>Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.&#xD;
Ifetroban, Oral Capsule</description>
        </group>
        <group group_id="P2">
          <title>Placebo, Oral Capsule</title>
          <description>Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.&#xD;
Placebo, Oral Capsule</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Inclusion or exclusion criteria not met</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Ifetroban, Oral Capsule</title>
          <description>Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.&#xD;
Ifetroban, Oral Capsule</description>
        </group>
        <group group_id="B2">
          <title>Placebo, Oral Capsule</title>
          <description>Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.&#xD;
Placebo, Oral Capsule</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
            <count group_id="B2" value="4"/>
            <count group_id="B3" value="16"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46" spread="11.6"/>
                    <measurement group_id="B2" value="43" spread="13.4"/>
                    <measurement group_id="B3" value="45" spread="11.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Proportion of Patients Who Experience a ≥ 20% Decrease in Forced Expiratory Volume in One Second (FEV1) Compared to Baseline Following a Dose of Investigational Medicinal Product (IMP) (Study Day 1 or 2) Prior to Initiation of the Aspirin Challenge</title>
        <time_frame>Study Day 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ifetroban, Oral Capsule</title>
            <description>Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.&#xD;
Ifetroban, Oral Capsule</description>
          </group>
          <group group_id="O2">
            <title>Placebo, Oral Capsule</title>
            <description>Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.&#xD;
Placebo, Oral Capsule</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients Who Experience a ≥ 20% Decrease in Forced Expiratory Volume in One Second (FEV1) Compared to Baseline Following a Dose of Investigational Medicinal Product (IMP) (Study Day 1 or 2) Prior to Initiation of the Aspirin Challenge</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients With a ≥ 25% Decrease in Peak Nasal Inspiratory Flow Rate Compared to Baseline Following a Dose of IMP (Study Day 1 or 2) Prior to Initiation of the Aspirin Challenge</title>
        <time_frame>Up to Study Day 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ifetroban, Oral Capsule</title>
            <description>Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.&#xD;
Ifetroban, Oral Capsule</description>
          </group>
          <group group_id="O2">
            <title>Placebo, Oral Capsule</title>
            <description>Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.&#xD;
Placebo, Oral Capsule</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients With a ≥ 25% Decrease in Peak Nasal Inspiratory Flow Rate Compared to Baseline Following a Dose of IMP (Study Day 1 or 2) Prior to Initiation of the Aspirin Challenge</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients With a ≥ 25% Increase in Total Nasal Symptom Score (TNSS) Compared to Baseline Following a Dose of IMP (Study Day 1 or 2) Prior to Initiation of the Aspirin Challenge</title>
        <time_frame>Up to Study Day 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ifetroban, Oral Capsule</title>
            <description>Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.&#xD;
Ifetroban, Oral Capsule</description>
          </group>
          <group group_id="O2">
            <title>Placebo, Oral Capsule</title>
            <description>Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.&#xD;
Placebo, Oral Capsule</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients With a ≥ 25% Increase in Total Nasal Symptom Score (TNSS) Compared to Baseline Following a Dose of IMP (Study Day 1 or 2) Prior to Initiation of the Aspirin Challenge</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence and Severity of Treatment-emergent Adverse Events</title>
        <time_frame>Up to Study Day 7</time_frame>
        <population>Number of subject reporting at least one adverse event</population>
        <group_list>
          <group group_id="O1">
            <title>Ifetroban, Oral Capsule</title>
            <description>Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.&#xD;
Ifetroban, Oral Capsule</description>
          </group>
          <group group_id="O2">
            <title>Placebo, Oral Capsule</title>
            <description>Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.&#xD;
Placebo, Oral Capsule</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence and Severity of Treatment-emergent Adverse Events</title>
          <population>Number of subject reporting at least one adverse event</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients Who Experience a ≥ 20% Decrease in FEV1 Compared to Baseline During the Aspirin Challenge</title>
        <time_frame>Study Day 2 and 3</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ifetroban, Oral Capsule</title>
            <description>Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.&#xD;
Ifetroban, Oral Capsule</description>
          </group>
          <group group_id="O2">
            <title>Placebo, Oral Capsule</title>
            <description>Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.&#xD;
Placebo, Oral Capsule</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients Who Experience a ≥ 20% Decrease in FEV1 Compared to Baseline During the Aspirin Challenge</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients With a ≥ 25% Decrease in Peak Nasal Inspiratory Flow Rate (NIFR) Compared to Baseline During the Aspirin Challenge</title>
        <time_frame>Study Day 2 and 3</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ifetroban, Oral Capsule</title>
            <description>Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.&#xD;
Ifetroban, Oral Capsule</description>
          </group>
          <group group_id="O2">
            <title>Placebo, Oral Capsule</title>
            <description>Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.&#xD;
Placebo, Oral Capsule</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients With a ≥ 25% Decrease in Peak Nasal Inspiratory Flow Rate (NIFR) Compared to Baseline During the Aspirin Challenge</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients With a ≥ 25% Increase in TNSS Compared to Baseline During the Aspirin Challenge</title>
        <time_frame>Study Day 2 and 3</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ifetroban, Oral Capsule</title>
            <description>Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.&#xD;
Ifetroban, Oral Capsule</description>
          </group>
          <group group_id="O2">
            <title>Placebo, Oral Capsule</title>
            <description>Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.&#xD;
Placebo, Oral Capsule</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients With a ≥ 25% Increase in TNSS Compared to Baseline During the Aspirin Challenge</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Amount of Rescue Medication Required During the Aspirin Challenge</title>
        <description>The amount of rescue medication required during the aspirin challenge</description>
        <time_frame>Study Day 2 and 3</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ifetroban, Oral Capsule</title>
            <description>Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.&#xD;
Ifetroban, Oral Capsule</description>
          </group>
          <group group_id="O2">
            <title>Placebo, Oral Capsule</title>
            <description>Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.&#xD;
Placebo, Oral Capsule</description>
          </group>
        </group_list>
        <measure>
          <title>Amount of Rescue Medication Required During the Aspirin Challenge</title>
          <description>The amount of rescue medication required during the aspirin challenge</description>
          <units>number of rescue medications</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread="2.02"/>
                    <measurement group_id="O2" value="7.33" spread="3.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence and Severity of Asthmatic Reactions During the Treatment Period</title>
        <time_frame>Study Day 1 through 3</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ifetroban, Oral Capsule</title>
            <description>Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.&#xD;
Ifetroban, Oral Capsule</description>
          </group>
          <group group_id="O2">
            <title>Placebo, Oral Capsule</title>
            <description>Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.&#xD;
Placebo, Oral Capsule</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence and Severity of Asthmatic Reactions During the Treatment Period</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients With an Aspirin Desensitization Dose Level of 30 mg, 60 mg, 100 mg, 150 mg, and 325 mg.</title>
        <time_frame>Study Day 2 and 3</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ifetroban, Oral Capsule</title>
            <description>Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.&#xD;
Ifetroban, Oral Capsule</description>
          </group>
          <group group_id="O2">
            <title>Placebo, Oral Capsule</title>
            <description>Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.&#xD;
Placebo, Oral Capsule</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients With an Aspirin Desensitization Dose Level of 30 mg, 60 mg, 100 mg, 150 mg, and 325 mg.</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>30 mg aspirin dose</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>60 mg aspirin dose</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>100mg aspirin dose</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>150 mg aspirin dose</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>325 mg aspirin dose</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No Aspirin Reaction</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>7 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Ifetroban, Oral Capsule</title>
          <description>Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.&#xD;
Ifetroban, Oral Capsule</description>
        </group>
        <group group_id="E2">
          <title>Placebo, Oral Capsule</title>
          <description>Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.&#xD;
Placebo, Oral Capsule</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 17.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye pruritis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Forced expiratory volume decreased</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Joint stiffness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Rhinnorrhea</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Sneezing</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Nasal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Throat irritation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Manger, Clinical Operations</name_or_title>
      <organization>Cumberland Pharmaceuticals Inc.</organization>
      <phone>615-255-0068 ext 250</phone>
      <email>bkaelin@cumberlandpharma.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02216357
org study id: CPI-IFE-003
nct id: NCT02216357
lead sponsor: 
has dmc: No
The primary objective of the study is to determine the safety of oral ifetroban compared to
      placebo as measured by a > 20% decrease in FEV1 compared to baseline following a dose of
      Investigational Medicinal Product (IMP) (Study Day 1 or 2) prior to initiation of the aspirin
      challenge.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Proportion of Patients Who Experience a ≥ 20% Decrease in Forced Expiratory Volume in One Second (FEV1) Compared to Baseline Following a Dose of Investigational Medicinal Product (IMP) (Study Day 1 or 2) Prior to Initiation of the Aspirin Challenge
time frame: Study Day 2
measure: Proportion of Patients With a ≥ 25% Decrease in Peak Nasal Inspiratory Flow Rate Compared to Baseline Following a Dose of IMP (Study Day 1 or 2) Prior to Initiation of the Aspirin Challenge
time frame: Up to Study Day 2
measure: Proportion of Patients With a ≥ 25% Increase in Total Nasal Symptom Score (TNSS) Compared to Baseline Following a Dose of IMP (Study Day 1 or 2) Prior to Initiation of the Aspirin Challenge
time frame: Up to Study Day 2
measure: Incidence and Severity of Treatment-emergent Adverse Events
time frame: Up to Study Day 7
measure: Proportion of Patients Who Experience a ≥ 20% Decrease in FEV1 Compared to Baseline During the Aspirin Challenge
time frame: Study Day 2 and 3
measure: Proportion of Patients With a ≥ 25% Decrease in Peak Nasal Inspiratory Flow Rate (NIFR) Compared to Baseline During the Aspirin Challenge
time frame: Study Day 2 and 3
measure: Proportion of Patients With a ≥ 25% Increase in TNSS Compared to Baseline During the Aspirin Challenge
time frame: Study Day 2 and 3
measure: Amount of Rescue Medication Required During the Aspirin Challenge
time frame: Study Day 2 and 3
description: The amount of rescue medication required during the aspirin challenge
measure: Incidence and Severity of Asthmatic Reactions During the Treatment Period
time frame: Study Day 1 through 3
measure: Proportion of Patients With an Aspirin Desensitization Dose Level of 30 mg, 60 mg, 100 mg, 150 mg, and 325 mg.
time frame: Study Day 2 and 3
arm group label: Ifetroban, Oral Capsule
arm group type: Active Comparator
description: Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.
arm group label: Placebo, Oral Capsule
arm group type: Placebo Comparator
description: Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.
intervention type: Drug
intervention name: Ifetroban, Oral Capsule
arm group label: Ifetroban, Oral Capsule
intervention type: Drug
intervention name: Placebo, Oral Capsule
arm group label: Placebo, Oral Capsule
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Respiratory Tract Diseases
mesh term: Respiration Disorders
mesh term: Ifetroban
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 