<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/NCT03762395</url>
  </required_header>
  <id_info>
    <org_study_id>19-0510; 21-3959</org_study_id>
    <secondary_id>5R01HL132550-03</secondary_id>
    <secondary_id>1R61HL157069-01A1</secondary_id>
    <nct_id>NCT03762395</nct_id>
  </id_info>
  <brief_title>Anti Inflammatory Lipid Mediators in Asthma Lipid Anti-Inflammtory Mediators in Asthma</brief_title>
  <acronym>ALMA; LIMA</acronym>
  <official_title>Anti Inflammatory Lipid Mediators in Asthma: A Double Blind Placebo Control Cross Over, Proof of Concept Study of CXA-10 to Reduce Bronchial Hyperresponsiveness in Obese Asthmatics; Lipid Anti-Inflammatory Mediators in Asthma to Reduce Hyperresponsiveness in Obese Asthmatics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>Yes</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 main purpose of this Phase 2 double blind, placebo controlled crossover clinical study is&#xD;
      to demonstrate the efficacy and safety of CXA-10 in obese adult asthmatics. Obesity induces a&#xD;
      chronic systemic inflammatory state characterized by impaired adipokine signaling,&#xD;
      pro-inflammatory cytokine responses, inflammatory cell activation and enhanced generation of&#xD;
      oxidative inflammatory mediators. This impacts the lung, increasing the severity of asthma&#xD;
      and its exacerbations. This research will evaluate how a synthetic nitro-fatty acid (CXA-10,&#xD;
      10-nitro-octadec-9-enoic acid) suppresses the systemic and airway inflammation that&#xD;
      contributes to the obese asthmatic phenotype. Current data support the pleiotropic signaling&#xD;
      actions of CXA-10 to induce adaptive signaling actions that beneficially modulate adipokine&#xD;
      and cytokine expression and inhibit systemic and pulmonary inflammation. The investigators&#xD;
      hypothesize that CXA-10 induced signaling responses will alleviate obesity-related airway&#xD;
      hyperreactivity in obese adult asthmatics.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 8, 2023</start_date>
  <completion_date type="Anticipated">January 30, 2029</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2028</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Methacholine challenge dose per spirometry</measure>
    <time_frame>Through study completion, up to 18 weeks</time_frame>
    <description>To determine CXA-10 efficacy, reduction of bronchial hyperresponsiveness determined by performing spirometry to see if there's a change in methacholine dose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in pre-bronchodilator FEV1 per spirometry</measure>
    <time_frame>Through study completion, up to 18 weeks</time_frame>
    <description>To determine the efficacy of CXA-10 by improving FEV1</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Asthma</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>CXA-10</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administered orally, continuously, and daily for at least 6 weeks. Dispensed at Visit 1. Washout period of at least 4 weeks and then enter crossover phase of an additional 6 weeks. Drug will be dispensed at Visit 4.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Matching Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Administered orally, daily, and continuously for at least 6 weeks. Dispensed at Visit 1. Washout period of at least 4 weeks and then enter crossover phase of an additional 6 weeks. Placebo will be dispensed at Visit 4.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CXA-10</intervention_name>
    <description>6 weeks of treatment with 150 mg/day of orally administered CXA-10</description>
    <arm_group_label>CXA-10</arm_group_label>
    <other_name>10-nitro-9(E)-octadec-9-enoic acid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Matching Placebo</intervention_name>
    <description>6 weeks of treatment with orally administered matching placebo (to 150 mg/day of CXA-10)</description>
    <arm_group_label>Matching Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adequate completion of informed consent process with written documentation. Male and&#xD;
             female patients, 18 to 65 years old. Female subjects should be either post-menopausal&#xD;
             or surgically sterile, or, if child-bearing potential (WOCP) should agree to use an&#xD;
             acceptable method of contraception, for the duration of the study, with a negative&#xD;
             pregnancy test prior to entering the study.&#xD;
&#xD;
          2. BMI &gt;/= 30&#xD;
&#xD;
          3. Diagnosis of asthma: based on previous physician diagnosis for &gt; 6 months, and&#xD;
             baseline pre-bronchodilator (BD) FEV1 between 50 and 95% predicted with either a 12%&#xD;
             or greater bronchodilator response to 4 puffs of albuterol or PC20 methacholine (16&#xD;
             mg) if &lt;12% change post BD&#xD;
&#xD;
          4. Regular treatment with inhaled corticosteroids (ICS) (up to 1000 mcg/day&#xD;
             fluticasone/equivalent), long acting beta agonists (LABA), and/or long-acting&#xD;
             muscarinic antagonists (LAMA), which can be combination medication for at least 3&#xD;
             months; on a stable dose for the 4 weeks prior to Visit 0&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Respiratory tract infection within the last 4 weeks&#xD;
&#xD;
          2. Oral or systemic corticosteroid burst within the last 4 weeks&#xD;
&#xD;
          3. Asthma-related hospitalization within the last 6 weeks&#xD;
&#xD;
          4. Three or more asthma exacerbations requiring treatment with systemic corticosteroids&#xD;
             in the past year consistent with severe asthma&#xD;
&#xD;
          5. Asthma-related ER visit within the previous 4 weeks&#xD;
&#xD;
          6. Current smoking or have former smokers that quit within the previous 1 year, or 10&#xD;
             pack years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fernando Holguin, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado Denver- Anschutz Medical Campus</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Asthma Research</last_name>
    <phone>1 (844) 365-0852</phone>
    <email>asthmaresearch@ucdenver.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Colorado Anschutz Medical Campus</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Asthma Research</last_name>
      <phone>844-365-0852</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>August 1, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>March 1, 2023</last_update_submitted>
  <last_update_submitted_qc>March 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 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>Asthma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>CXA-10</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/NCT03762395
org study id: 19-0510; 21-3959
secondary id: 5R01HL132550-03
secondary id: 1R61HL157069-01A1
nct id: NCT03762395
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The main purpose of this Phase 2 double blind, placebo controlled crossover clinical study is
      to demonstrate the efficacy and safety of CXA-10 in obese adult asthmatics. Obesity induces a
      chronic systemic inflammatory state characterized by impaired adipokine signaling,
      pro-inflammatory cytokine responses, inflammatory cell activation and enhanced generation of
      oxidative inflammatory mediators. This impacts the lung, increasing the severity of asthma
      and its exacerbations. This research will evaluate how a synthetic nitro-fatty acid (CXA-10,
      10-nitro-octadec-9-enoic acid) suppresses the systemic and airway inflammation that
      contributes to the obese asthmatic phenotype. Current data support the pleiotropic signaling
      actions of CXA-10 to induce adaptive signaling actions that beneficially modulate adipokine
      and cytokine expression and inhibit systemic and pulmonary inflammation. The investigators
      hypothesize that CXA-10 induced signaling responses will alleviate obesity-related airway
      hyperreactivity in obese adult asthmatics.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in Methacholine challenge dose per spirometry
time frame: Through study completion, up to 18 weeks
description: To determine CXA-10 efficacy, reduction of bronchial hyperresponsiveness determined by performing spirometry to see if there's a change in methacholine dose
measure: Changes in pre-bronchodilator FEV1 per spirometry
time frame: Through study completion, up to 18 weeks
description: To determine the efficacy of CXA-10 by improving FEV1
arm group label: CXA-10
arm group type: Experimental
description: Administered orally, continuously, and daily for at least 6 weeks. Dispensed at Visit 1. Washout period of at least 4 weeks and then enter crossover phase of an additional 6 weeks. Drug will be dispensed at Visit 4.
arm group label: Matching Placebo
arm group type: Placebo Comparator
description: Administered orally, daily, and continuously for at least 6 weeks. Dispensed at Visit 1. Washout period of at least 4 weeks and then enter crossover phase of an additional 6 weeks. Placebo will be dispensed at Visit 4.
intervention type: Drug
intervention name: CXA-10
description: 6 weeks of treatment with 150 mg/day of orally administered CXA-10
arm group label: CXA-10
other name: 10-nitro-9(E)-octadec-9-enoic acid
intervention type: Drug
intervention name: Matching Placebo
description: 6 weeks of treatment with orally administered matching placebo (to 150 mg/day of CXA-10)
arm group label: Matching Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Fernando Holguin, MD, MPH
role: Principal Investigator
affiliation: University of Colorado Denver- Anschutz Medical Campus
last name: Asthma Research
phone: 1 (844) 365-0852
email: asthmaresearch@ucdenver.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Asthma
mesh term: CXA-10
sharing ipd: No