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EoE RCT Fluticasone and Omeprazole vs Fluticasone Alone

Primary Purpose

Eosinophilic Esophagitis

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Retrospective evaluation of endoscopy prior to study drug
Symptom Survey
Medication Compliance Phone Call
Endoscopy while on study drug
Symptom Survey
Fluticasone
Omeprazole
Placebo oral capsule
Sponsored by
Claire Daniels
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Eosinophilic Esophagitis

Eligibility Criteria

6 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age 6 to 60 years old
  • DEERS (defense enrollment eligibility reporting system) eligible
  • diagnosis of eosinophilic esophagitis

Exclusion Criteria:

  • Outside of age range
  • Co-existing inflammatory gastroenterologic condition such as celiac disease, eosinophilic esophagitis, or inflammatory bowel disease.
  • Concurrent use of oral steroids
  • Pregnancy
  • Refusal to undergo endoscopy

Sites / Locations

  • Walter Reed National Military Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fluticasone and omeprazole

Fluticasone and placebo

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in esophageal eosinophilia
The number of eosinophils per high powered field will be counted by participating pathologist.

Secondary Outcome Measures

Change in Endoscopic Reference Score
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).
Change in Symptom Scoring
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.

Full Information

First Posted
November 11, 2018
Last Updated
December 17, 2018
Sponsor
Claire Daniels
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1. Study Identification

Unique Protocol Identification Number
NCT03781596
Brief Title
EoE RCT Fluticasone and Omeprazole vs Fluticasone Alone
Official Title
Randomized Controlled Trial Comparing Fluticasone Plus Omeprazole With Fluticasone Alone for Eosinophilic Esophagitis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 2, 2018 (Actual)
Primary Completion Date
October 2, 2020 (Anticipated)
Study Completion Date
October 2, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Claire Daniels

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Esophagitis

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fluticasone and omeprazole
Arm Type
Experimental
Arm 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 Title
Fluticasone and placebo
Arm Type
Placebo Comparator
Arm 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(s)
Retrospective evaluation of endoscopy prior to study drug
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Symptom Survey
Intervention Description
Patient will complete symptom survey prior to starting the study drugs.
Intervention Type
Other
Intervention Name(s)
Medication Compliance Phone Call
Intervention 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Endoscopy while on study drug
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Symptom Survey
Intervention Description
The patient will complete a symptom survey after 8 weeks on the study drugs, and the change in survey score will be measured.
Intervention Type
Drug
Intervention Name(s)
Fluticasone
Intervention Description
Participants in the experimental and placebo arms will be given swallowed fluticasone for an 8 week course. Doses determined by age and weight.
Intervention Type
Drug
Intervention Name(s)
Omeprazole
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention 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).
Primary Outcome Measure Information:
Title
Change in esophageal eosinophilia
Description
The number of eosinophils per high powered field will be counted by participating pathologist.
Time Frame
There will be one at week 0 and week 8.
Secondary Outcome Measure Information:
Title
Change in Endoscopic Reference Score
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).
Time Frame
This will be done at week 0 and week 8
Title
Change in Symptom Scoring
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.
Time Frame
Week 0 and week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 6 to 60 years old DEERS (defense enrollment eligibility reporting system) eligible diagnosis of eosinophilic esophagitis Exclusion Criteria: Outside of age range Co-existing inflammatory gastroenterologic condition such as celiac disease, eosinophilic esophagitis, or inflammatory bowel disease. Concurrent use of oral steroids Pregnancy Refusal to undergo endoscopy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steve B Min, M.D.
Phone
301-295-4959
Email
steve.b.min.mil@mail.mil
First Name & Middle Initial & Last Name or Official Title & Degree
Claire P Daniels, M.D.
Phone
301-295-4959
Email
claire.p.daniels.mil@mail.mil
Facility Information:
Facility Name
Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire P Daniels, M.D.
Phone
443-904-3353
Email
claire.p.daniels.mil@mail.mil

12. IPD Sharing Statement

Plan to Share IPD
No
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EoE RCT Fluticasone and Omeprazole vs Fluticasone Alone

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