Cycling of Topical Steroids for Treatment of EoE (Eosinopilic Esophagitis)

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of Cycling of Topical Steroid Therapy in Maintaining Clinical and Histologic Remission in Eosinophilic Esophagitis

Conditions
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Eosinophilic Esophagitis

Intervention / Treatment
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* Drug: Fluticasone Propionate
* Drug: Budesonide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric patients between 4-18 years of age with EoE followed by the Division of Pediatric Gastroenterology, Hepatology and Nutrition at Rainbow Babies and Children's Hospital Patients who are currently on treatment with topical corticosteroids and scheduled for an upcoming endoscopy as part of their routine clinical care (to be used as EGD1) within 3 months of enrollment date Patients who have achieved documented clinical and endoscopic remission using topical steroids as evidenced by EGD Exclusion Criteria: Patients who are not responsive to topical corticosteroid treatment for their EoE as evidenced by failure to obtain clinical or endoscopic remission on any pervious screening EGD Patients less than 4 years of age and older than 18 years of age at the time of recruitment Patients with history of or current diagnosis of esophageal strictures

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Participants in this arm will continue with their normal standard of care regimen of daily topical steroids | |
| Experimental: Intervention<br>Participants in this arm will cycle their topical steroid therapy in a three-months on three-months off fashion | Drug: Fluticasone Propionate<br>* Participants will cycle topical steroid in a three-months on three-months off fashion<br>Drug: Budesonide<br>* Participants will cycle topical steroid in a three-months on three-months off fashion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of patients in remission at one year as measured by EGD |  | up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of patients who report adverse events as measured by patient report |  | up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fluticasone, Budesonide, Adolescent, Cycling