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Cycling of Topical Steroids for Treatment of EoE (Eosinopilic Esophagitis)

Primary Purpose

Eosinophilic Esophagitis

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Fluticasone Propionate

Budesonide

About this trial

This is an interventional treatment trial for Eosinophilic Esophagitis focused on measuring Fluticasone, Budesonide, Adolescent, Cycling

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospitals Cleveland Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

Percent of patients in remission at one year as measured by EGD

Secondary Outcome Measures

Percent of patients who report adverse events as measured by patient report

Full Information

NCT ID

NCT05444543

First Posted

June 28, 2022

Last Updated

July 3, 2023

Sponsor

University Hospitals Cleveland Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT05444543

Brief Title

Cycling of Topical Steroids for Treatment of EoE (Eosinopilic Esophagitis)

Official Title

Effectiveness of Cycling of Topical Steroid Therapy in Maintaining Clinical and Histologic Remission in Eosinophilic Esophagitis

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 17, 2021 (Actual)

Primary Completion Date

October 31, 2023 (Anticipated)

Study Completion Date

October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospitals Cleveland Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Eosinophilic Esophagitis

Keywords

Fluticasone, Budesonide, Adolescent, Cycling

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

Participants in this arm will continue with their normal standard of care regimen of daily topical steroids

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Participants in this arm will cycle their topical steroid therapy in a three-months on three-months off fashion

Intervention Type

Drug

Intervention Name(s)

Fluticasone Propionate

Intervention Description

Participants will cycle topical steroid in a three-months on three-months off fashion

Intervention Type

Drug

Intervention Name(s)

Budesonide

Intervention Description

Participants will cycle topical steroid in a three-months on three-months off fashion

Primary Outcome Measure Information:

Title

Percent of patients in remission at one year as measured by EGD

Time Frame

up to one year

Secondary Outcome Measure Information:

Title

Percent of patients who report adverse events as measured by patient report

Time Frame

up to 12 months

Other Pre-specified Outcome Measures:

Title

Change in quality of life as measured by Modified-PedsQL™ Eosinophilic Esophagitis Module Child Self-Report Item Content

Description

14 item questionnaire where patients either agree or disagree

Time Frame

Baseline, 3 months, 6 months, 12 months

Title

Percent of patients with elevated IL-13 as measured by biopsy

Time Frame

up to 12 months

Title

Percent of patients with elevated eotaxin as measured by biopsy

Time Frame

up to 12 months

Title

Percentage of patients who develop subclinical adrenal insufficiency as measured by blood work

Time Frame

up to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nuphar Lendner, MD

Phone

216-844-1765

Nuphar.Lendner@UHhospitals.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Sferra, MD

Organizational Affiliation

University Hospitals Cleveland Medical Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Nuphar Lendner, MD

Organizational Affiliation

University Hospitals Cleveland Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospitals Cleveland Medical Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nuphar Lendner, MD

Phone

216-844-1765

Nuphar.Lendner@UHhospitals.org

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Cycling of Topical Steroids for Treatment of EoE (Eosinopilic Esophagitis)

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