NCT05444543

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 4 Years – 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2021-11-17
• Primary completion: 2023-10-13
• Completion: 2023-10-13
• First posted: 2022-07-06
• Last updated: 2024-11-07
• Results posted: 2024-11-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study