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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Participants in this arm will continue with their normal standard of care regimen of daily topical steroids | |
| Intervention | Experimental | Participants in this arm will cycle their topical steroid therapy in a three-months on three-months off fashion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone Propionate | Drug | Participants will cycle topical steroid in a three-months on three-months off fashion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to one year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Report Adverse Events as Measured by Patient Report | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life as Measured by Modified-PedsQLâ„¢ Eosinophilic Esophagitis Module Child Self-Report Item Content | 14 item questionnaire where patients either agree or disagree | Baseline, 3 months, 6 months, 12 months |
| Percent of Patients With Elevated IL-13 as Measured by Biopsy |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Sferra, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Nuphar Lendner, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Participants in this arm will continue with their normal standard of care regimen of daily topical steroids |
| FG001 | Intervention | Participants in this arm will cycle their topical steroid therapy in a three-months on three-months off fashion Fluticasone Propionate: Participants will cycle topical steroid in a three-months on three-months off fashion Budesonide: Participants will cycle topical steroid in a three-months on three-months off fashion |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Participants in this arm will continue with their normal standard of care regimen of daily topical steroids |
| BG001 | Intervention | Participants in this arm will cycle their topical steroid therapy in a three-months on three-months off fashion Fluticasone Propionate: Participants will cycle topical steroid in a three-months on three-months off fashion Budesonide: Participants will cycle topical steroid in a three-months on three-months off fashion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | up to one year |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Participants in this arm will continue with their normal standard of care regimen of daily topical steroids |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | SNOMED CT | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thomas Sferra | University Hospitals Cleveland Medical Center | (216)844-1765 | Thomas.Sferra@UHhospitals.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 12, 2021 | Oct 10, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D057765 | Eosinophilic Esophagitis |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Budesonide | Drug | Participants will cycle topical steroid in a three-months on three-months off fashion |
|
| up to 12 months |
| up to 12 months |
| Percent of Patients With Elevated Eotaxin as Measured by Biopsy | up to 12 months |
| Adverse Event |
|
| Family relocating at a distance from study site |
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
|
| Secondary | Number of Patients Who Report Adverse Events as Measured by Patient Report | Includes all enrolled participants, number of participants reporting an adverse event | Posted | Count of Participants | Participants | up to 12 months |
|
|
|
|
| Secondary | 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. | Includes all enrolled participants and those who had cortisol levels obtained at the scheduled time. | Posted | Number | participants | up to 12 months |
|
|
|
| Other Pre-specified | Change in Quality of Life as Measured by Modified-PedsQLâ„¢ Eosinophilic Esophagitis Module Child Self-Report Item Content | 14 item questionnaire where patients either agree or disagree | Not Posted | Baseline, 3 months, 6 months, 12 months | Participants |
| Other Pre-specified | Percent of Patients With Elevated IL-13 as Measured by Biopsy | Not Posted | up to 12 months | Participants |
| Other Pre-specified | Percent of Patients With Elevated Eotaxin as Measured by Biopsy | Not Posted | up to 12 months | Participants |
| 0 |
| 11 |
| 0 |
| 11 |
| 2 |
| 11 |
| EG001 | Intervention | Participants in this arm will cycle their topical steroid therapy in a three-months on three-months off fashion Fluticasone Propionate: Participants will cycle topical steroid in a three-months on three-months off fashion Budesonide: Participants will cycle topical steroid in a three-months on three-months off fashion | 0 | 12 | 0 | 12 | 2 | 12 |
| Nausea | Gastrointestinal disorders | SNOMED CT | Non-systematic Assessment |
|
| Candidiasis of mouth | Infections and infestations | SNOMED CT | Non-systematic Assessment |
|
| Ulcer of mouth | Gastrointestinal disorders | SNOMED CT | Non-systematic Assessment |
|
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| D005759 |
| Gastroenteritis |
| D004802 | Eosinophilia |
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |