<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/NCT03781596</url>
  </required_header>
  <id_info>
    <org_study_id>WRNMMC-2018-0133</org_study_id>
    <nct_id>NCT03781596</nct_id>
  </id_info>
  <brief_title>EoE RCT Fluticasone and Omeprazole vs Fluticasone Alone</brief_title>
  <official_title>Randomized Controlled Trial Comparing Fluticasone Plus Omeprazole With Fluticasone Alone for Eosinophilic Esophagitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Claire Daniels</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Walter Reed National Military Medical Center</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy of combination therapy with omeprazole&#xD;
      and swallowed fluticasone vs fluticasone therapy and placebo in the treatment of Eosinophilic&#xD;
      Esophagitis (EoE) in children and adults. This study will be a double-blinded, randomized&#xD;
      controlled trial. The primary outcome measured will be histologic assessment of esophageal&#xD;
      tissue biopsies measuring number of eosinophils per high power field (eos/hpf). Secondary&#xD;
      outcomes will be endoscopic findings and symptomatic changes following therapy using&#xD;
      validated endoscopic scoring measures and participant surveys, respectively.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects that meet study inclusion criteria will be recruited from the Adult and Pediatric&#xD;
      Gastroenterology clinics at Walter Reed National Military Medical Center through routine&#xD;
      clinic visits, will meet with an investigator, and complete informed consent/assent. The&#xD;
      participants will then complete a validated clinical symptom reporting tool - the&#xD;
      Eosinophilic Esophagitis symptom activity index (EEsAI) for age 18 and above, or the&#xD;
      Pediatric Quality of Life Inventory (PedsQL) for age 6-17yrs - and have their initial&#xD;
      Esophagogastroduodenoscopy (EGD) images evaluated via a validated Endoscopic Reference Score&#xD;
      (EREFS). Esophageal biopsies taken at the patient's initial EGD will be assessed by 2&#xD;
      designated blinded pathologists to record the number of eosinophils per high power field&#xD;
      (HPF), as well as perform tissue immunohistochemical staining for eotaxin-3. Participants&#xD;
      will be block randomized to treatment or control groups and complete 8 weeks of therapy, with&#xD;
      a phone follow up at 4 weeks for medication compliance. At the completion of 8 weeks of&#xD;
      therapy, the participants will have repeat EGD to assess for mucosal healing, which is the&#xD;
      standard of care in the treatment of EoE. At this EGD, the images will be assigned an EREFS&#xD;
      and the biopsies will be evaluated for eosinophils per high powered field and eotaxin-3&#xD;
      staining. The patient will also complete an EEsAI or PedsQL. This procedure will end the 8&#xD;
      week study period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 2, 2018</start_date>
  <completion_date type="Anticipated">October 2, 2022</completion_date>
  <primary_completion_date type="Anticipated">October 2, 2020</primary_completion_date>
  <phase>Phase 4</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>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in esophageal eosinophilia</measure>
    <time_frame>There will be one at week 0 and week 8.</time_frame>
    <description>The number of eosinophils per high powered field will be counted by participating pathologist.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Endoscopic Reference Score</measure>
    <time_frame>This will be done at week 0 and week 8</time_frame>
    <description>Endoscopic appearance will be evaluated with a validated scoring method: Minimum score 0, maximum score 10. Scores come from 5 outcomes: Fixed rings (0-3 points), exudates (0-2 points), furrows (0-2 points), edema (0-2 points), stricture (0-1 points).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Symptom Scoring</measure>
    <time_frame>Week 0 and week 8</time_frame>
    <description>Clinical changes will be evaluated by either one of 2 validated tools: Eosinophilic Esophagitis symptom activity index (EEsAI) for age 18 and above, or the Pediatric Quality of Life Inventory (PedsQL) for age 6-17yrs.&#xD;
Both of these tools are considered proprietary and we have permission from the companies to use this scoring system for research - and their grading scales were provided. Copyright for PedsQL - JW Varni 1998. Confidentiality for EEsAI scoring - EEsAI Study Group at the University of Bern.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Eosinophilic Esophagitis</condition>
  <arm_group>
    <arm_group_label>Fluticasone and omeprazole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>These patients will be prescribed swallowed fluticasone and omeprazole to be taken together for the 8 week period. Dosing will be based on weight and age. Primary outcome measure will be the change in esophageal biopsy histology, or number of eosinophils per high powered field, from week 0 to week 8. Secondary outcomes will include changes in the following variables between week 0 and 8: eotaxin staining of the esophageal biopsy tissue, endoscopic scoring from photos of the esophagus obtained during endoscopy, and symptom scoring based on surveys.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fluticasone and placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>These patients will be prescribed swallowed fluticasone and a placebo medication that appears identical to omeprazole to be taken together for an 8 week period. Dosing will be based on weight and age. Primary outcome measure will be the change in esophageal biopsy histology, or number of eosinophils per high powered field, from week 0 to week 8. Secondary outcomes will include changes in the following variables between week 0 and 8: eotaxin staining of the esophageal biopsy tissue, endoscopic scoring from photos of the esophagus obtained during endoscopy, and symptom scoring based on surveys.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Retrospective evaluation of endoscopy prior to study drug</intervention_name>
    <description>Once enrolled, the patient's original endoscopy will be evaluated including the images from the EGD and the biopsies for eotaxin 3 staining and eosinophilic burden.</description>
    <arm_group_label>Fluticasone and omeprazole</arm_group_label>
    <arm_group_label>Fluticasone and placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Symptom Survey</intervention_name>
    <description>Patient will complete symptom survey prior to starting the study drugs.</description>
    <arm_group_label>Fluticasone and omeprazole</arm_group_label>
    <arm_group_label>Fluticasone and placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Medication Compliance Phone Call</intervention_name>
    <description>The patient will receive a phone call at 4 weeks to evaluate medication compliance including the number on the inhaler and the number of pills remaining in the container.</description>
    <arm_group_label>Fluticasone and omeprazole</arm_group_label>
    <arm_group_label>Fluticasone and placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Endoscopy while on study drug</intervention_name>
    <description>Endoscopy will be performed after 8 weeks of therapy. Endoscopic scoring will be assigned and the histology will be evaluated, including eotaxin 3 staining. The change in eosinophil count and eotaxin staining will be measured.</description>
    <arm_group_label>Fluticasone and omeprazole</arm_group_label>
    <arm_group_label>Fluticasone and placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Symptom Survey</intervention_name>
    <description>The patient will complete a symptom survey after 8 weeks on the study drugs, and the change in survey score will be measured.</description>
    <arm_group_label>Fluticasone and omeprazole</arm_group_label>
    <arm_group_label>Fluticasone and placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluticasone</intervention_name>
    <description>Participants in the experimental and placebo arms will be given swallowed fluticasone for an 8 week course. Doses determined by age and weight.</description>
    <arm_group_label>Fluticasone and omeprazole</arm_group_label>
    <arm_group_label>Fluticasone and placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Omeprazole</intervention_name>
    <description>The participants in the experimental arm will be given oral omprazole capsules for an 8 week period (along with the swallowed fluticasone). Doses determined by age and weight.</description>
    <arm_group_label>Fluticasone and omeprazole</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo oral capsule</intervention_name>
    <description>The participants in the placebo arm will be given placebo capsules for an 8 week period (along with the swallowed fluticasone). Number of pills determined by age and weight (to match omeprazole dosing).</description>
    <arm_group_label>Fluticasone and placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 6 to 60 years old&#xD;
&#xD;
          -  DEERS (defense enrollment eligibility reporting system) eligible&#xD;
&#xD;
          -  diagnosis of eosinophilic esophagitis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Outside of age range&#xD;
&#xD;
          -  Co-existing inflammatory gastroenterologic condition such as celiac disease,&#xD;
             eosinophilic esophagitis, or inflammatory bowel disease.&#xD;
&#xD;
          -  Concurrent use of oral steroids&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Refusal to undergo endoscopy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Steve B Min, M.D.</last_name>
    <phone>301-295-4959</phone>
    <email>steve.b.min.mil@mail.mil</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Claire P Daniels, M.D.</last_name>
    <phone>301-295-4959</phone>
    <email>claire.p.daniels.mil@mail.mil</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Walter Reed National Military Medical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20889</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claire P Daniels, M.D.</last_name>
      <phone>443-904-3353</phone>
      <email>claire.p.daniels.mil@mail.mil</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Liacouras CA, Furuta GT, Hirano I, Atkins D, Attwood SE, Bonis PA, Burks AW, Chehade M, Collins MH, Dellon ES, Dohil R, Falk GW, Gonsalves N, Gupta SK, Katzka DA, Lucendo AJ, Markowitz JE, Noel RJ, Odze RD, Putnam PE, Richter JE, Romero Y, Ruchelli E, Sampson HA, Schoepfer A, Shaheen NJ, Sicherer SH, Spechler S, Spergel JM, Straumann A, Wershil BK, Rothenberg ME, Aceves SS. Eosinophilic esophagitis: updated consensus recommendations for children and adults. J Allergy Clin Immunol. 2011 Jul;128(1):3-20.e6; quiz 21-2. doi: 10.1016/j.jaci.2011.02.040. Epub 2011 Apr 7.</citation>
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    <citation>Liacouras CA, Wenner WJ, Brown K, Ruchelli E. Primary eosinophilic esophagitis in children: successful treatment with oral corticosteroids. J Pediatr Gastroenterol Nutr. 1998 Apr;26(4):380-5. doi: 10.1097/00005176-199804000-00004.</citation>
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    <citation>Papadopoulou A, Dias JA. Eosinophilic esophagitis: an emerging disease in childhood - review of diagnostic and management strategies. Front Pediatr. 2014 Nov 21;2:129. doi: 10.3389/fped.2014.00129. eCollection 2014.</citation>
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    <citation>Konikoff MR, Noel RJ, Blanchard C, Kirby C, Jameson SC, Buckmeier BK, Akers R, Cohen MB, Collins MH, Assa'ad AH, Aceves SS, Putnam PE, Rothenberg ME. A randomized, double-blind, placebo-controlled trial of fluticasone propionate for pediatric eosinophilic esophagitis. Gastroenterology. 2006 Nov;131(5):1381-91. doi: 10.1053/j.gastro.2006.08.033. Epub 2006 Aug 16.</citation>
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    <citation>Dohil R, Newbury R, Fox L, Bastian J, Aceves S. Oral viscous budesonide is effective in children with eosinophilic esophagitis in a randomized, placebo-controlled trial. Gastroenterology. 2010 Aug;139(2):418-29. doi: 10.1053/j.gastro.2010.05.001. Epub 2010 May 7.</citation>
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    <citation>Butz BK, Wen T, Gleich GJ, Furuta GT, Spergel J, King E, Kramer RE, Collins MH, Stucke E, Mangeot C, Jackson WD, O'Gorman M, Abonia JP, Pentiuk S, Putnam PE, Rothenberg ME. Efficacy, dose reduction, and resistance to high-dose fluticasone in patients with eosinophilic esophagitis. Gastroenterology. 2014 Aug;147(2):324-33.e5. doi: 10.1053/j.gastro.2014.04.019. Epub 2014 Apr 22.</citation>
    <PMID>24768678</PMID>
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  <reference>
    <citation>Alexander JA, Jung KW, Arora AS, Enders F, Katzka DA, Kephardt GM, Kita H, Kryzer LA, Romero Y, Smyrk TC, Talley NJ. Swallowed fluticasone improves histologic but not symptomatic response of adults with eosinophilic esophagitis. Clin Gastroenterol Hepatol. 2012 Jul;10(7):742-749.e1. doi: 10.1016/j.cgh.2012.03.018. Epub 2012 Apr 1.</citation>
    <PMID>22475741</PMID>
  </reference>
  <reference>
    <citation>Asher Wolf W, Dellon ES. Eosinophilic esophagitis and proton pump inhibitors: controversies and implications for clinical practice. Gastroenterol Hepatol (N Y). 2014 Jul;10(7):427-32.</citation>
    <PMID>25904830</PMID>
  </reference>
  <reference>
    <citation>Moawad FJ, Veerappan GR, Dias JA, Baker TP, Maydonovitch CL, Wong RK. Randomized controlled trial comparing aerosolized swallowed fluticasone to esomeprazole for esophageal eosinophilia. Am J Gastroenterol. 2013 Mar;108(3):366-72. doi: 10.1038/ajg.2012.443. Epub 2013 Feb 12.</citation>
    <PMID>23399553</PMID>
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    <citation>Bullock JZ, Villanueva JM, Blanchard C, Filipovich AH, Putnam PE, Collins MH, Risma KA, Akers RM, Kirby CL, Buckmeier BK, Assa'ad AH, Hogan SP, Rothenberg ME. Interplay of adaptive th2 immunity with eotaxin-3/c-C chemokine receptor 3 in eosinophilic esophagitis. J Pediatr Gastroenterol Nutr. 2007 Jul;45(1):22-31. doi: 10.1097/MPG.0b013e318043c097.</citation>
    <PMID>17592361</PMID>
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  <reference>
    <citation>Blanchard C, Mingler MK, Vicario M, Abonia JP, Wu YY, Lu TX, Collins MH, Putnam PE, Wells SI, Rothenberg ME. IL-13 involvement in eosinophilic esophagitis: transcriptome analysis and reversibility with glucocorticoids. J Allergy Clin Immunol. 2007 Dec;120(6):1292-300. doi: 10.1016/j.jaci.2007.10.024.</citation>
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    <citation>Park JY, Zhang X, Nguyen N, Souza RF, Spechler SJ, Cheng E. Proton pump inhibitors decrease eotaxin-3 expression in the proximal esophagus of children with esophageal eosinophilia. PLoS One. 2014 Jul 2;9(7):e101391. doi: 10.1371/journal.pone.0101391. eCollection 2014.</citation>
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    <citation>Zhang X, Huo X, Yu C, Zhang Q, Nadatani Y, Tamagawa Y, et al. Omeprazole and fluticasone inhibit IL-13-stimulated eotaxin-3 expression by esophageal epithelial cells through different mechanisms and with additive effects: Rationale for combining PPIs with topical steroids for EoE patients. Gastroenterology 2015;148(4, Supplement 1):S-51.</citation>
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    <citation>Dellon ES, Gonsalves N, Hirano I, Furuta GT, Liacouras CA, Katzka DA; American College of Gastroenterology. ACG clinical guideline: Evidenced based approach to the diagnosis and management of esophageal eosinophilia and eosinophilic esophagitis (EoE). Am J Gastroenterol. 2013 May;108(5):679-92; quiz 693. doi: 10.1038/ajg.2013.71. Epub 2013 Apr 9.</citation>
    <PMID>23567357</PMID>
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    <citation>Papadopoulou A, Koletzko S, Heuschkel R, Dias JA, Allen KJ, Murch SH, Chong S, Gottrand F, Husby S, Lionetti P, Mearin ML, Ruemmele FM, Schappi MG, Staiano A, Wilschanski M, Vandenplas Y; ESPGHAN Eosinophilic Esophagitis Working Group and the Gastroenterology Committee. Management guidelines of eosinophilic esophagitis in childhood. J Pediatr Gastroenterol Nutr. 2014 Jan;58(1):107-18. doi: 10.1097/MPG.0b013e3182a80be1.</citation>
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    <citation>Dellon ES, Cotton CC, Gebhart JH, Higgins LL, Beitia R, Woosley JT, Shaheen NJ. Accuracy of the Eosinophilic Esophagitis Endoscopic Reference Score in Diagnosis and Determining Response to Treatment. Clin Gastroenterol Hepatol. 2016 Jan;14(1):31-9. doi: 10.1016/j.cgh.2015.08.040. Epub 2015 Sep 25. Erratum In: Clin Gastroenterol Hepatol. 2016 Jun;14 (6):919.</citation>
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    <citation>Hirano I, Moy N, Heckman MG, Thomas CS, Gonsalves N, Achem SR. Endoscopic assessment of the oesophageal features of eosinophilic oesophagitis: validation of a novel classification and grading system. Gut. 2013 Apr;62(4):489-95. doi: 10.1136/gutjnl-2011-301817. Epub 2012 May 22.</citation>
    <PMID>22619364</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>December 17, 2018</last_update_submitted>
  <last_update_submitted_qc>December 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Walter Reed National Military Medical Center</investigator_affiliation>
    <investigator_full_name>Claire Daniels</investigator_full_name>
    <investigator_title>Associate Investigator</investigator_title>
  </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>Omeprazole</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 2, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/96/NCT03781596/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 2, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/96/NCT03781596/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03781596
org study id: WRNMMC-2018-0133
nct id: NCT03781596
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose of this study is to evaluate the efficacy of combination therapy with omeprazole
      and swallowed fluticasone vs fluticasone therapy and placebo in the treatment of Eosinophilic
      Esophagitis (EoE) in children and adults. This study will be a double-blinded, randomized
      controlled trial. The primary outcome measured will be histologic assessment of esophageal
      tissue biopsies measuring number of eosinophils per high power field (eos/hpf). Secondary
      outcomes will be endoscopic findings and symptomatic changes following therapy using
      validated endoscopic scoring measures and participant surveys, respectively.
Subjects that meet study inclusion criteria will be recruited from the Adult and Pediatric
      Gastroenterology clinics at Walter Reed National Military Medical Center through routine
      clinic visits, will meet with an investigator, and complete informed consent/assent. The
      participants will then complete a validated clinical symptom reporting tool - the
      Eosinophilic Esophagitis symptom activity index (EEsAI) for age 18 and above, or the
      Pediatric Quality of Life Inventory (PedsQL) for age 6-17yrs - and have their initial
      Esophagogastroduodenoscopy (EGD) images evaluated via a validated Endoscopic Reference Score
      (EREFS). Esophageal biopsies taken at the patient's initial EGD will be assessed by 2
      designated blinded pathologists to record the number of eosinophils per high power field
      (HPF), as well as perform tissue immunohistochemical staining for eotaxin-3. Participants
      will be block randomized to treatment or control groups and complete 8 weeks of therapy, with
      a phone follow up at 4 weeks for medication compliance. At the completion of 8 weeks of
      therapy, the participants will have repeat EGD to assess for mucosal healing, which is the
      standard of care in the treatment of EoE. At this EGD, the images will be assigned an EREFS
      and the biopsies will be evaluated for eosinophils per high powered field and eotaxin-3
      staining. The patient will also complete an EEsAI or PedsQL. This procedure will end the 8
      week study period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in esophageal eosinophilia
time frame: There will be one at week 0 and week 8.
description: The number of eosinophils per high powered field will be counted by participating pathologist.
measure: Change in Endoscopic Reference Score
time frame: This will be done at week 0 and week 8
description: Endoscopic appearance will be evaluated with a validated scoring method: Minimum score 0, maximum score 10. Scores come from 5 outcomes: Fixed rings (0-3 points), exudates (0-2 points), furrows (0-2 points), edema (0-2 points), stricture (0-1 points).
measure: Change in Symptom Scoring
time frame: Week 0 and week 8
description: Clinical changes will be evaluated by either one of 2 validated tools: Eosinophilic Esophagitis symptom activity index (EEsAI) for age 18 and above, or the Pediatric Quality of Life Inventory (PedsQL) for age 6-17yrs.
Both of these tools are considered proprietary and we have permission from the companies to use this scoring system for research - and their grading scales were provided. Copyright for PedsQL - JW Varni 1998. Confidentiality for EEsAI scoring - EEsAI Study Group at the University of Bern.
arm group label: Fluticasone and omeprazole
arm group type: Experimental
description: These patients will be prescribed swallowed fluticasone and omeprazole to be taken together for the 8 week period. Dosing will be based on weight and age. Primary outcome measure will be the change in esophageal biopsy histology, or number of eosinophils per high powered field, from week 0 to week 8. Secondary outcomes will include changes in the following variables between week 0 and 8: eotaxin staining of the esophageal biopsy tissue, endoscopic scoring from photos of the esophagus obtained during endoscopy, and symptom scoring based on surveys.
arm group label: Fluticasone and placebo
arm group type: Placebo Comparator
description: These patients will be prescribed swallowed fluticasone and a placebo medication that appears identical to omeprazole to be taken together for an 8 week period. Dosing will be based on weight and age. Primary outcome measure will be the change in esophageal biopsy histology, or number of eosinophils per high powered field, from week 0 to week 8. Secondary outcomes will include changes in the following variables between week 0 and 8: eotaxin staining of the esophageal biopsy tissue, endoscopic scoring from photos of the esophagus obtained during endoscopy, and symptom scoring based on surveys.
intervention type: Diagnostic Test
intervention name: Retrospective evaluation of endoscopy prior to study drug
description: Once enrolled, the patient's original endoscopy will be evaluated including the images from the EGD and the biopsies for eotaxin 3 staining and eosinophilic burden.
arm group label: Fluticasone and omeprazole
arm group label: Fluticasone and placebo
intervention type: Other
intervention name: Symptom Survey
description: Patient will complete symptom survey prior to starting the study drugs.
arm group label: Fluticasone and omeprazole
arm group label: Fluticasone and placebo
intervention type: Other
intervention name: Medication Compliance Phone Call
description: The patient will receive a phone call at 4 weeks to evaluate medication compliance including the number on the inhaler and the number of pills remaining in the container.
arm group label: Fluticasone and omeprazole
arm group label: Fluticasone and placebo
intervention type: Diagnostic Test
intervention name: Endoscopy while on study drug
description: Endoscopy will be performed after 8 weeks of therapy. Endoscopic scoring will be assigned and the histology will be evaluated, including eotaxin 3 staining. The change in eosinophil count and eotaxin staining will be measured.
arm group label: Fluticasone and omeprazole
arm group label: Fluticasone and placebo
intervention type: Other
intervention name: Symptom Survey
description: The patient will complete a symptom survey after 8 weeks on the study drugs, and the change in survey score will be measured.
arm group label: Fluticasone and omeprazole
arm group label: Fluticasone and placebo
intervention type: Drug
intervention name: Fluticasone
description: Participants in the experimental and placebo arms will be given swallowed fluticasone for an 8 week course. Doses determined by age and weight.
arm group label: Fluticasone and omeprazole
arm group label: Fluticasone and placebo
intervention type: Drug
intervention name: Omeprazole
description: The participants in the experimental arm will be given oral omprazole capsules for an 8 week period (along with the swallowed fluticasone). Doses determined by age and weight.
arm group label: Fluticasone and omeprazole
intervention type: Drug
intervention name: Placebo oral capsule
description: The participants in the placebo arm will be given placebo capsules for an 8 week period (along with the swallowed fluticasone). Number of pills determined by age and weight (to match omeprazole dosing).
arm group label: Fluticasone and placebo
criteria: 
gender: All
minimum age: 6 Years
maximum age: 60 Years
healthy volunteers: No
last name: Steve B Min, M.D.
phone: 301-295-4959
email: steve.b.min.mil@mail.mil
last name: Claire P Daniels, M.D.
phone: 301-295-4959
email: claire.p.daniels.mil@mail.mil
facility: 
status: Recruiting
contact: 
country: United States
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responsible party type: Sponsor-Investigator
investigator affiliation: Walter Reed National Military Medical Center
investigator full name: Claire Daniels
investigator title: Associate Investigator
mesh term: Esophagitis
mesh term: Eosinophilic Esophagitis
mesh term: Fluticasone
mesh term: Omeprazole
sharing ipd: No
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