Eosinophilic Esophagitis
Conditions
Keywords
Fluticasone, Budesonide, Adolescent, Cycling
Brief 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.
Interventions
DRUGFluticasone Propionate
Participants will cycle topical steroid in a three-months on three-months off fashion
DRUGBudesonide
Participants will cycle topical steroid in a three-months on three-months off fashion
Sponsors
University Hospitals Cleveland Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Patients in Remission at One Year as Measured by EGD | up to one year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | up to 12 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life as Measured by Modified-PedsQL™ Eosinophilic Esophagitis Module Child Self-Report Item Content | Baseline, 3 months, 6 months, 12 months | 14 item questionnaire where patients either agree or disagree |
| Percent of Patients With Elevated IL-13 as Measured by Biopsy | up to 12 months | — |
| Percent of Patients With Elevated Eotaxin as Measured by Biopsy | up to 12 months | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Participants in this arm will continue with their normal standard of care regimen of daily topical steroids | 11 |
| 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 | 12 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Failed to achieve initial remission on therapy | 1 | 0 |
| Overall Study | Family relocating at a distance from study site | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Intervention | Total | Control |
|---|---|---|---|
| Age, Continuous | 15.5 Years STANDARD_DEVIATION 3.2 | 12.5 Years STANDARD_DEVIATION 3.7 | 11.6 Years STANDARD_DEVIATION 3.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 22 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 21 Participants | 11 Participants |
| Sex: Female, Male Female | 5 Participants | 9 Participants | 4 Participants |
| Sex: Female, Male Male | 7 Participants | 14 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 12 |
| other Total, other adverse events | 2 / 11 | 2 / 12 |
| serious Total, serious adverse events | 0 / 11 | 0 / 12 |
Outcome results
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.
Time frame: up to one year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Percent of Patients in Remission at One Year as Measured by EGD | 5 Participants |
| Intervention | Percent of Patients in Remission at One Year as Measured by EGD | 1 Participants |
p-value: 0.57Chi-squared
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.
Time frame: up to 12 months
Population: Includes all enrolled participants and those who had cortisol levels obtained at the scheduled time.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Number of Patients Who Develop Subclinical Adrenal Insufficiency as Measured by Blood Work | 4 participants |
| Intervention | Number of Patients Who Develop Subclinical Adrenal Insufficiency as Measured by Blood Work | 6 participants |
Secondary
Number of Patients Who Report Adverse Events as Measured by Patient Report
Time frame: up to 12 months
Population: Includes all enrolled participants, number of participants reporting an adverse event
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Patients Who Report Adverse Events as Measured by Patient Report | 1 Participants |
| Intervention | Number of Patients Who Report Adverse Events as Measured by Patient Report | 1 Participants |
p-value: >0.99Chi-squared
Other Pre-specified
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
Other Pre-specified
Percent of Patients With Elevated Eotaxin as Measured by Biopsy
Time frame: up to 12 months
Other Pre-specified
Percent of Patients With Elevated IL-13 as Measured by Biopsy
Time frame: up to 12 months