EoE RCT Fluticasone and Omeprazole vs Fluticasone Alone

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.

Conditions

• Eosinophilic Esophagitis

Interventions

DIAGNOSTIC_TEST

Retrospective evaluation of endoscopy prior to study drug

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.

OTHER

Symptom Survey

Patient will complete symptom survey prior to starting the study drugs.

OTHER

Medication Compliance Phone Call

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.

DIAGNOSTIC_TEST

Endoscopy while on study drug

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.

OTHER

Symptom Survey

The patient will complete a symptom survey after 8 weeks on the study drugs, and the change in survey score will be measured.

DRUG

Fluticasone

Participants in the experimental and placebo arms will be given swallowed fluticasone for an 8 week course. Doses determined by age and weight.

DRUG

Omeprazole

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.

DRUG

Placebo oral capsule

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).

Sponsors & Collaborators

• Claire Daniels

  lead FED

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-10-02

Primary Completion

2020-10-02

Completion

2022-10-02

FDA Drug

Yes

Countries

• United States

Study Locations