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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
All Individual Drugs Already Approved
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent of Patients in Remission at One Year as Measured by EGD
Secondary study objectives
Number of Patients Who Develop Subclinical Adrenal Insufficiency as Measured by Blood Work
Other study objectives
Change in Quality of Life as Measured by Modified-PedsQL™ Eosinophilic Esophagitis Module Child Self-Report Item Content

Side effects data

From 2016 Phase 4 trial • 222 Patients • NCT02055352
9%
Influenza
9%
Nasopharyngitis
8%
Headache
7%
Dysphonia
6%
Urinary tract infection
6%
Arthralgia
5%
Back pain
2%
Chronic obstructive pulmonary disease
1%
Vascular insufficiency
1%
Venous thrombosis limb
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)

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
324 Previous Clinical Trials
342,901 Total Patients Enrolled
Thomas Sferra, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center
1 Previous Clinical Trials
20 Total Patients Enrolled
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: Control, Intervention
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
~6 spots leftby Nov 2025
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