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

NCT05444543 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: STUDY20210671
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Eosinophilic Esophagitis

Keywords

Fluticasone; Budesonide; Adolescent; Cycling

Outcome Measures

Primary Outcomes (1)

• Percent of Patients in Remission at One Year as Measured by EGD

  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.

  up to one year

Secondary Outcomes (2)

• 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

Other Outcomes (3)

• 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

• Percent of Patients With Elevated IL-13 as Measured by Biopsy

  up to 12 months

• Percent of Patients With Elevated Eotaxin as Measured by Biopsy

  up to 12 months

Study Arms (2)

Control

NO INTERVENTION

Participants in this arm will continue with their normal standard of care regimen of daily topical steroids

Intervention

EXPERIMENTAL

Participants in this arm will cycle their topical steroid therapy in a three-months on three-months off fashion

Drug: Fluticasone Propionate; Drug: Budesonide

Interventions

Fluticasone Propionate DRUG

Participants will cycle topical steroid in a three-months on three-months off fashion

Intervention

Budesonide DRUG

Participants will cycle topical steroid in a three-months on three-months off fashion

Intervention

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Eosinophilic Esophagitis

Interventions

Fluticasone; Budesonide

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnenediones; Pregnenes; Pregnanes

Results Point of Contact

• Title: Dr. Thomas Sferra
• Organization: University Hospitals Cleveland Medical Center

Thomas.Sferra@UHhospitals.org

(216)844-1765

Study Officials

• Thomas Sferra, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

• Nuphar Lendner, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Pediatric Gastroenterology Hepatology and Nutrition

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 6, 2022
• Study Start: November 17, 2021
• Primary Completion: October 13, 2023
• Study Completion: October 13, 2023
• Last Updated: November 7, 2024
• Results First Posted: November 7, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)