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

NCT05444543 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2024-11-07

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • University Hospitals Cleveland Medical Center

    lead OTHER

Principal Investigators

  • Thomas Sferra, MD · University Hospitals Cleveland Medical Center

  • Nuphar Lendner, MD · University Hospitals Cleveland Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-17
Primary Completion
2023-10-13
Completion
2023-10-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05444543 on ClinicalTrials.gov