EoE RCT Fluticasone and Omeprazole vs Fluticasone Alone

Claire Daniels

Status and phase: Unknown; Phase 4

Conditions: Eosinophilic Esophagitis

Treatments: Other: Symptom Survey; Diagnostic Test: Retrospective evaluation of endoscopy prior to study drug; Other: Medication Compliance Phone Call; Drug: Omeprazole; Drug: Placebo oral capsule; Diagnostic Test: Endoscopy while on study drug; Drug: Fluticasone

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03781596

WRNMMC-2018-0133

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 6 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Fluticasone and omeprazole

Experimental group

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.

Treatment:

Other: Symptom Survey

Diagnostic Test: Endoscopy while on study drug

Other: Medication Compliance Phone Call

Other: Symptom Survey

Drug: Omeprazole

Diagnostic Test: Retrospective evaluation of endoscopy prior to study drug

Drug: Fluticasone

Fluticasone and placebo

Placebo Comparator group

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.

Treatment:

Drug: Placebo oral capsule

Other: Symptom Survey

Diagnostic Test: Endoscopy while on study drug

Other: Medication Compliance Phone Call

Other: Symptom Survey

Diagnostic Test: Retrospective evaluation of endoscopy prior to study drug

Drug: Fluticasone