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Corticosteroid

Budesonide for Eosinophilic Esophagitis

Phase 4
Waitlist Available
Led By Thomas Sferra, MD
Research Sponsored by University Hospitals Cleveland Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to one year
Awards & highlights

Study Summary

This trial is testing whether people with a certain kind of esophageal disease can take breaks from their treatment while still remaining in remission.

Eligible Conditions
  • Eosinophilic Esophagitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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
Other outcome measures
Change in quality of life as measured by Modified-PedsQL™ Eosinophilic Esophagitis Module Child Self-Report Item Content
Percent of patients with elevated IL-13 as measured by biopsy
Percent of patients with elevated eotaxin as measured by biopsy
+1 more

Side effects data

From 2016 Phase 4 trial • 222 Patients • NCT02055352
9%
Nasopharyngitis
9%
Influenza
8%
Headache
7%
Dysphonia
6%
Urinary tract infection
6%
Arthralgia
5%
Back pain
2%
Chronic obstructive pulmonary disease
1%
Venous thrombosis limb
1%
Vascular insufficiency
1%
Peripheral arterial occlusive disease
1%
Acute myocardial infarction
1%
Cor pulmonale
1%
Nodal arrhythmia
1%
Pneumonia
1%
Hip fracture
1%
Hepatocellular carcinoma
1%
Acute pulmonary oedema
1%
Bradycardia
1%
Cellulitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fluticasone / Salmeterol (B)
Budesonide / Indacaterol (A)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment2 Interventions
Participants in this arm will cycle their topical steroid therapy in a three-months on three-months off fashion
Group II: ControlActive Control1 Intervention
Participants in this arm will continue with their normal standard of care regimen of daily topical steroids
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Budesonide
FDA approved
Fluticasone propionate
FDA approved

Find a Location

Who is running the clinical trial?

University Hospitals Cleveland Medical CenterLead Sponsor
317 Previous Clinical Trials
340,331 Total Patients Enrolled
Thomas Sferra, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center
Nuphar Lendner, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center

Media Library

Budesonide (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05444543 — Phase 4
Eosinophilic Esophagitis Research Study Groups: Intervention, Control
Eosinophilic Esophagitis Clinical Trial 2023: Budesonide Highlights & Side Effects. Trial Name: NCT05444543 — Phase 4
Budesonide (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05444543 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being included in this research endeavor?

"Affirmative. Clinicaltrials.gov provides evidence that this clinical trial, which was initially uploaded on November 17th 2021, is actively recruiting participants. Thirty individuals will be accepted from one center for the study duration."

Answered by AI

Is this experiment open for enrollment to the public?

"Affirmative. According to the information listed on clinicaltrials.gov, this research endeavour is still searching for candidates; it was first posted in November 2021 and its most recent amendment occurred July 2022. This trial currently seeks 30 volunteers from a single medical site."

Answered by AI

Could you please elucidate the safety profile of Budesonide?

"There is a substantial body of evidence indicating the safety of Budesonide, thus it was assigned a rating of 3."

Answered by AI

Are any individuals aged 70 or above eligible to partake in this experiment?

"As per the specified standards, only individuals aged 4 to 18 are eligible for enrollment in this medical trial."

Answered by AI

What criteria must an individual meet to qualify for involvement in this medical experiment?

"The enrolment criteria for this clinical trial mandates that potential participants must have eosinophilic esophagitis and fall between the ages of 4 to 18. Currently, the researchers are actively recruiting around 30 patients."

Answered by AI
~7 spots leftby Mar 2025