Cycling of Topical Steroids for Treatment of EoE (Eosinopilic Esophagitis)
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.
Timeline
- Start
- 2021-11-17
- Primary completion
- 2023-10-13
- Completion
- 2023-10-13
Outcome
Missed primary endpoint
registry COUNT_OF_PARTICIPANTS Control: 5 Participants NCT05444543 ↗
registry COUNT_OF_PARTICIPANTS Intervention: 1 Participants NCT05444543 ↗
registry analysis (superiority test); Control vs Intervention; p = 0.57; Odds Ratio (OR) 0.089; Chi-squared NCT05444543 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Budesonide | Small molecule | — | Topical |
| Subject | Fluticasone propionate | Other / unclassified | — | Topical |