Intervention for Eosinophilic Esophagitis

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
University Hospitals Cleveland Medical Center, Cleveland, OH
Eosinophilic Esophagitis+1 More
Budesonide - Drug
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of our research study is to assess whether patients with EoE who have achieved control of their disease on topical Fluticasone or Budesonide are able to cycle or take breaks from their treatment with continued remission of their EoE. There will be 30 participants enrolled in this study. There will be 15 patients who will stay on steroid therapy every day and 15 patients who will cycle their steroid therapy on and off to help us compare the two groups. The cycling group will cycle their steroid therapy in a three-months on three-months off fashion.

Eligible Conditions

  • Eosinophilic Esophagitis

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: up to one year

Month 12
Change in quality of life as measured by Modified-PedsQL™ Eosinophilic Esophagitis Module Child Self-Report Item Content
up to 12 months
Percent of patients who report adverse events as measured by patient report
Percent of patients with elevated IL-13 as measured by biopsy
Percent of patients with elevated eotaxin as measured by biopsy
Percentage of patients who develop subclinical adrenal insufficiency as measured by blood work
up to one year
Percent of patients in remission at one year as measured by EGD

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Control
1 of 2
Intervention
1 of 2
Active Control
Experimental Treatment

30 Total Participants · 2 Treatment Groups

Primary Treatment: Intervention · No Placebo Group · Phase 4

InterventionExperimental Group · 2 Interventions: Budesonide, Fluticasone Propionate · Intervention Types: Drug, Drug
ControlNoIntervention Group · 1 Intervention: Control · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Budesonide
2017
Completed Phase 4
~13210
Fluticasone Propionate
2011
Completed Phase 4
~3500

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to one year

Trial Background

Thomas J Sferra, MD
Principal Investigator
University Hospitals Cleveland Medical Center
Closest Location: University Hospitals Cleveland Medical Center · Cleveland, OH
Photo of university hospitals cleveland medical center  1Photo of university hospitals cleveland medical center  2Photo of university hospitals cleveland medical center  3
2011First Recorded Clinical Trial
1 TrialsResearching Eosinophilic Esophagitis
172 CompletedClinical Trials

Eligibility Criteria

Age < 65 · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have achieved documented clinical and endoscopic remission using topical steroids as evidenced by EGD.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.