<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/NCT01702701</url>
  </required_header>
  <id_info>
    <org_study_id>MCWEoEMVF</org_study_id>
    <nct_id>NCT01702701</nct_id>
  </id_info>
  <brief_title>Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone</brief_title>
  <official_title>Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical College of Wisconsin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical College of Wisconsin</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will compare response to treatment of Eosinophilic Esophagitis with montelukast vs&#xD;
      standard therapy fluticasone. Investigators hypothesize that montelukast is equally effective&#xD;
      in treating symptoms and histology of EoE when compared to fluticasone. The study will be&#xD;
      conducted at multiple sites with Medical College of Wisconsin as the coordinating site. After&#xD;
      identification and recruitment all patients will be randomized (provider blinded) to one of&#xD;
      two medications: montelukast 10mg po qday vs fluticasone 440mcg po bid. Patients will also&#xD;
      complete a pretreatment, 6 week therapy and 12 week therapy questionaire. They will then&#xD;
      undergo a repeat endoscopy to evaluate endoscopic and histologic response.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eosinophilic esophagitis is an allergic condition of the esophagus with an incidence that is&#xD;
      on the rise, and has limited treatment options. Current gold standard of treatment is with&#xD;
      topical steroids (swallowed fluticasone). There is preliminary data that oral montelukast may&#xD;
      prove to be effective in inducing and maintaining symptomatic along with histologic remission&#xD;
      of this disease. Investigators will be comparing the effectiveness of singulair to swallowed&#xD;
      fluticasone in inducing and maintaining histologic and symptomatic remission of eosinophilic&#xD;
      esophagitis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">July 20, 2017</completion_date>
  <primary_completion_date type="Actual">July 20, 2017</primary_completion_date>
  <phase>Phase 3</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in Dysphagia symptom score</measure>
    <time_frame>3 month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in esophageal histology counts of eosinophils/hpf</measure>
    <time_frame>3 month</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Eosinophilic Esophagitis</condition>
  <condition>Dysphagia</condition>
  <arm_group>
    <arm_group_label>Montelukast</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients will receive 10 mg po montelukast daily for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fluticasone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients will receive 440mcg fluticasone po bid for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Montelukast</intervention_name>
    <description>montelukast 10mg po pill q day for 12 weeks</description>
    <arm_group_label>Montelukast</arm_group_label>
    <other_name>Singulair</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluticasone</intervention_name>
    <description>fluticasone 440mcg po q bid x 12 weeks</description>
    <arm_group_label>Fluticasone</arm_group_label>
    <other_name>Flovent</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a confirmed diagnosis of EoE on biopsy&#xD;
&#xD;
          -  with &gt;15 eos per HPF&#xD;
&#xD;
          -  ages &gt;18&#xD;
&#xD;
          -  Both male and Female.&#xD;
&#xD;
          -  Not pregnant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  patients receiving ongoing medical therapy for EoE&#xD;
&#xD;
          -  patients who underwent dilation in the last 12 weeks with improvement in symptoms&#xD;
&#xD;
          -  LA grade B or worse erosive esophagitis.&#xD;
&#xD;
          -  age &lt; 18&#xD;
&#xD;
          -  nursing mothers&#xD;
&#xD;
          -  use of prohibited concomitant medications : budesonide-oral compounded liquid,&#xD;
             fluticasone or montelukast.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Walter Hogan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical College of Wisconsin</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nikhil Shastri, MD</last_name>
    <role>Study Director</role>
    <affiliation>Medical College of Wisconsin</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GI Associates</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>October 4, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2012</study_first_posted>
  <last_update_submitted>August 26, 2019</last_update_submitted>
  <last_update_submitted_qc>August 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2019</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>Esophagitis</mesh_term>
    <mesh_term>Eosinophilic Esophagitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluticasone</mesh_term>
    <mesh_term>Montelukast</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/NCT01702701
org study id: MCWEoEMVF
nct id: NCT01702701
lead sponsor: 
has dmc: No
This study will compare response to treatment of Eosinophilic Esophagitis with montelukast vs
      standard therapy fluticasone. Investigators hypothesize that montelukast is equally effective
      in treating symptoms and histology of EoE when compared to fluticasone. The study will be
      conducted at multiple sites with Medical College of Wisconsin as the coordinating site. After
      identification and recruitment all patients will be randomized (provider blinded) to one of
      two medications: montelukast 10mg po qday vs fluticasone 440mcg po bid. Patients will also
      complete a pretreatment, 6 week therapy and 12 week therapy questionaire. They will then
      undergo a repeat endoscopy to evaluate endoscopic and histologic response.
Eosinophilic esophagitis is an allergic condition of the esophagus with an incidence that is
      on the rise, and has limited treatment options. Current gold standard of treatment is with
      topical steroids (swallowed fluticasone). There is preliminary data that oral montelukast may
      prove to be effective in inducing and maintaining symptomatic along with histologic remission
      of this disease. Investigators will be comparing the effectiveness of singulair to swallowed
      fluticasone in inducing and maintaining histologic and symptomatic remission of eosinophilic
      esophagitis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Improvement in Dysphagia symptom score
time frame: 3 month
measure: Improvement in esophageal histology counts of eosinophils/hpf
time frame: 3 month
arm group label: Montelukast
arm group type: Active Comparator
description: patients will receive 10 mg po montelukast daily for 12 weeks.
arm group label: Fluticasone
arm group type: Active Comparator
description: patients will receive 440mcg fluticasone po bid for 12 weeks
intervention type: Drug
intervention name: Montelukast
description: montelukast 10mg po pill q day for 12 weeks
arm group label: Montelukast
other name: Singulair
intervention type: Drug
intervention name: Fluticasone
description: fluticasone 440mcg po q bid x 12 weeks
arm group label: Fluticasone
other name: Flovent
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Walter Hogan, MD
role: Principal Investigator
affiliation: Medical College of Wisconsin
last name: Nikhil Shastri, MD
role: Study Director
affiliation: Medical College of Wisconsin
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Esophagitis
mesh term: Eosinophilic Esophagitis
mesh term: Fluticasone
mesh term: Montelukast