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

Phase 4

Completed

• Conditions: Eosinophilic Esophagitis
• Interventions: Drug: Fluticasone Propionate; Drug: Budesonide

• Registration Number: NCT05444543
• Lead Sponsor: University Hospitals Cleveland Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-17
• Study First Submitted: 2022-06-28
• Study First Submitted QC: 2022-07-01
• Study First Posted: 2022-07-06
• Primary Completion: 2023-10-13
• Study Completion: 2023-10-13
• Status Verified: 2024-10
• Results First Submitted: 2024-10-11
• Results First Submitted QC: 2024-10-11
• Last Update Submitted: 2024-10-11
• Results First Posted: 2024-11-07
• Last Update Posted: 2024-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Fluticasone Propionate	Participants in this arm will cycle their topical steroid therapy in a three-months on three-months off fashion
Intervention	Budesonide	Participants in this arm will cycle their topical steroid therapy in a three-months on three-months off fashion

Primary Outcome Measures

Name	Time	Method
Percent of Patients in Remission at One Year as Measured by EGD	up to one year	The outcome measure is the number of participants who maintained remission (less than or equal to 15 eosinophils per high powered field in esophageal biopsies) for one year after demonstration of a therapeutic effect of topical steroid therapy.

Secondary Outcome Measures

Name	Time	Method
Number of Patients Who Report Adverse Events as Measured by Patient Report	up to 12 months
Number of Patients Who Develop Subclinical Adrenal Insufficiency as Measured by Blood Work	up to 12 months	Subclinical adrenal insufficiency was defined as a morning cortisol level less than 10.0 micrograms per deciliter. One low level at anytime during the study period was recorded as an insufficient level.

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States