Trial Outcomes & Findings for Cycling of Topical Steroids for Treatment of EoE (Eosinopilic Esophagitis) (NCT NCT05444543)
NCT ID: NCT05444543
Last Updated: 2024-11-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
23 participants
Primary outcome timeframe
up to one year
Results posted on
2024-11-07
Participant Flow
Participant milestones
| Measure |
Control
Participants in this arm will continue with their normal standard of care regimen of daily topical steroids
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
12
|
|
Overall Study
COMPLETED
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Control
Participants in this arm will continue with their normal standard of care regimen of daily topical steroids
|
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Failed to achieve initial remission on therapy
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Family relocating at a distance from study site
|
0
|
1
|
Baseline Characteristics
Cycling of Topical Steroids for Treatment of EoE (Eosinopilic Esophagitis)
Baseline characteristics by cohort
| Measure |
Control
n=11 Participants
Participants in this arm will continue with their normal standard of care regimen of daily topical steroids
|
Intervention
n=12 Participants
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
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
11.6 Years
STANDARD_DEVIATION 3.4 • n=5 Participants
|
15.5 Years
STANDARD_DEVIATION 3.2 • n=7 Participants
|
12.5 Years
STANDARD_DEVIATION 3.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to one yearThe 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.
Outcome measures
| Measure |
Control
n=9 Participants
Participants in this arm will continue with their normal standard of care regimen of daily topical steroids
|
Intervention
n=10 Participants
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
|
|---|---|---|
|
Percent of Patients in Remission at One Year as Measured by EGD
|
5 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 12 monthsPopulation: Includes all enrolled participants, number of participants reporting an adverse event
Outcome measures
| Measure |
Control
n=11 Participants
Participants in this arm will continue with their normal standard of care regimen of daily topical steroids
|
Intervention
n=12 Participants
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
|
|---|---|---|
|
Number of Patients Who Report Adverse Events as Measured by Patient Report
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 12 monthsPopulation: Includes all enrolled participants and those who had cortisol levels obtained at the scheduled time.
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.
Outcome measures
| Measure |
Control
n=7 Participants
Participants in this arm will continue with their normal standard of care regimen of daily topical steroids
|
Intervention
n=12 Participants
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
|
|---|---|---|
|
Number of Patients Who Develop Subclinical Adrenal Insufficiency as Measured by Blood Work
|
4 participants
|
6 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3 months, 6 months, 12 months14 item questionnaire where patients either agree or disagree
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 12 monthsOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 12 monthsOutcome measures
Outcome data not reported
Adverse Events
Control
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Intervention
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control
n=11 participants at risk
Participants in this arm will continue with their normal standard of care regimen of daily topical steroids
|
Intervention
n=12 participants at risk
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
|
|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/11 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11 • 1 year
|
8.3%
1/12 • Number of events 1 • 1 year
|
|
Infections and infestations
Candidiasis of mouth
|
9.1%
1/11 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
|
Gastrointestinal disorders
Ulcer of mouth
|
9.1%
1/11 • Number of events 1 • 1 year
|
0.00%
0/12 • 1 year
|
Additional Information
Dr. Thomas Sferra
University Hospitals Cleveland Medical Center
Phone: (216)844-1765
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place