Phase 4
N=23
Cycling of Topical Steroids for Treatment of EoE (Eosinopilic Esophagitis)
Eosinophilic Esophagitis
Bottom Line
View on ClinicalTrials.gov: NCT05444543 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Percent of Patients in Remission at One Year as Measured by EGD — 5; 1 Participants — p=0.57
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Fluticasone Propionate (Drug); Budesonide (Drug)
- Age
- Pediatric, Adult · 4+ yrs
- Sex
- All
- Sponsor
- University Hospitals Cleveland Medical Center
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Patients in Remission at One Year as Measured by EGD |
5; 1 | 0.57 |
| SECONDARY Number of Patients Who Report Adverse Events as Measured by Patient Report |
1; 1 | >0.99 |
| SECONDARY Number of Patients Who Develop Subclinical Adrenal Insufficiency as Measured by Blood Work |
4; 6 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05444543). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.