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

• Sponsor: University Hospitals Cleveland Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05444543
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 23.4
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Eosinophilic Esophagitis	Drug: Fluticasone Propionate; Drug: Budesonide	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effectiveness of Cycling of Topical Steroid Therapy in Maintaining Clinical and Histologic Remission in Eosinophilic Esophagitis
• Actual Study Start Date: Nov 17, 2021
• Anticipated Primary Completion Date: Oct 31, 2023
• Anticipated Study Completion Date: Oct 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Percent of patients in remission at one year as measured by EGD [up to one year]

Secondary Outcome Measures

1. Percent of patients who report adverse events as measured by patient report [up to 12 months]

Other Outcome Measures

1. Change in quality of life as measured by Modified-PedsQL™ Eosinophilic Esophagitis Module Child Self-Report Item Content [Baseline, 3 months, 6 months, 12 months]

   14 item questionnaire where patients either agree or disagree

2. Percent of patients with elevated IL-13 as measured by biopsy [up to 12 months]

3. Percent of patients with elevated eotaxin as measured by biopsy [up to 12 months]

4. Percentage of patients who develop subclinical adrenal insufficiency as measured by blood work [up to 12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals Cleveland Medical Center	Cleveland	Ohio	United States	44106

Sponsors and Collaborators

• University Hospitals Cleveland Medical Center

Investigators

• Principal Investigator: Thomas Sferra, MD, University Hospitals Cleveland Medical Center
• Principal Investigator: Nuphar Lendner, MD, University Hospitals Cleveland Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Thomas J Sferra, MD, Chief of Pediatric Gastroenterology Hepatology and Nutrition, University Hospitals Cleveland Medical Center
• ClinicalTrials.gov Identifier: NCT05444543
• Other Study ID Numbers: STUDY20210671
• First Posted: Jul 6, 2022
• Last Update Posted: Jul 6, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Thomas J Sferra, MD, Chief of Pediatric Gastroenterology Hepatology and Nutrition, University Hospitals Cleveland Medical Center: Fluticasone; Budesonide; Adolescent; Cycling
• Additional relevant MeSH terms: Esophagitis; Eosinophilic Esophagitis; Fluticasone; Xhance; Budesonide

Study Results

No Results Posted as of Jul 6, 2022