A Phase 4 interventional study of Fluticasone Propionate and Budesonide in Eosinophilic Esophagitis, sponsored by University Hospitals Cleveland Medical Center. Completed at 1 site in United States. Open to participants aged 4 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-11-07.
Sponsored by University Hospitals Cleveland Medical Center · Phase 4, Interventional, and Treatment
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.
322 studies on the registry are indexed under Esophagitis; 38 are open to participants now.
This study's enrollment of 23 is below the median of 66 across 215 interventional studies indexed under Esophagitis.
Browse Esophagitis studies →University Hospitals Cleveland Medical Center is the lead sponsor of 283 studies on the registry; 42 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 29 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in this arm will continue with their normal standard of care regimen of daily topical steroids
Participants in this arm will cycle their topical steroid therapy in a three-months on three-months off fashion
Drug: Fluticasone Propionate · Drug: Budesonide
Participants will cycle topical steroid in a three-months on three-months off fashion
Participants will cycle topical steroid in a three-months on three-months off fashion
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.
Time frame: up to one year
Number of Patients Who Report Adverse Events as Measured by Patient Report
Time frame: up to 12 months
Number of Patients Who Develop Subclinical Adrenal Insufficiency as Measured by Blood Work
Subclinical adrenal insufficiency was defined as a morning cortisol level less than 10.0 micrograms per deciliter. One low level at anytime during the study period was recorded as an insufficient level.
Time frame: up to 12 months
Change in Quality of Life as Measured by Modified-PedsQL™ Eosinophilic Esophagitis Module Child Self-Report Item Content
14 item questionnaire where patients either agree or disagree
Time frame: Baseline, 3 months, 6 months, 12 months
Percent of Patients With Elevated IL-13 as Measured by Biopsy
Time frame: up to 12 months
Percent of Patients With Elevated Eotaxin as Measured by Biopsy
Time frame: up to 12 months
| Milestone | Control | Intervention |
|---|---|---|
| Started | 11 | 12 |
| Completed | 9 | 10 |
| Not completed | 2 | 2 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Failed to achieve initial remission on therapy | 1 | 0 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Family relocating at a distance from study site | 0 | 1 |
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.
| Participants | Control | Intervention |
|---|---|---|
| Percent of Patients in Remission at One Year as Measured by EGD | 5 | 1 |
| Participants | Control | Intervention |
|---|---|---|
| Number of Patients Who Report Adverse Events as Measured by Patient Report | 1 | 1 |
Subclinical adrenal insufficiency was defined as a morning cortisol level less than 10.0 micrograms per deciliter. One low level at anytime during the study period was recorded as an insufficient level.
| participants | Control | Intervention |
|---|---|---|
| Number of Patients Who Develop Subclinical Adrenal Insufficiency as Measured by Blood Work | 4 | 6 |
14 item questionnaire where patients either agree or disagree
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | 0/11 (0%) | 0/11 (0%) | 2/11 (18.2%) |
| Intervention | 0/12 (0%) | 0/12 (0%) | 2/12 (16.7%) |
| Event | Control | Intervention |
|---|---|---|
| Candidiasis of mouthInfections and infestations | 1/11 | 0/12 |
| Ulcer of mouthGastrointestinal disorders | 1/11 | 0/12 |
| HeadacheNervous system disorders | 0/11 | 1/12 |
| NauseaGastrointestinal disorders | 0/11 | 1/12 |
| Age, Continuous(Years) | Control | Intervention | Total |
|---|---|---|---|
| Mean | 11.6 ± 3.4 | 15.5 ± 3.2 | 12.5 ± 3.7 |
| Sex: Female, Male(Participants) | Control | Intervention | Total |
|---|---|---|---|
| Female | 4 | 5 | 9 |
| Male | 7 | 7 | 14 |
| Ethnicity (NIH/OMB)(Participants) | Control | Intervention | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 11 | 11 | 22 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Control | Intervention | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 11 | 10 | 21 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 2 | 2 |
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University Hospitals Cleveland Medical Center