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Budesonide for Eosinophilic Esophagitis

This study is looking at two different ways to take budesonide orodispersible tablets to treat Eosinophilic Esophagitis (EoE), a chronic allergic inflammatory disease of the esophagus. Researchers want to see if taking 1 mg of budesonide once a day (BID) is as effective as taking 2 mg of budesonide twice a day for 6 weeks. You might be able to join if you are between 18 and 75 years old, have an active diagnosis of EoE, and meet other health criteria. The main goal is to see what percentage of patients achieve remission (improvement in symptoms and inflammation) after 6 weeks of treatment. The current status of this study is unclear.

Study design
This interventional study plans to enroll 308 participants. It compares two different dosing schedules of budesonide orodispersible tablets.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 6 weeks, indicating the duration of the main treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06596252

Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE

Active, Not Recruiting
PHASE3Ages 18–75InterventionalTreatment
Dr. Falk Pharma GmbH
~308 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:Budesonide

At a glance

Recruiting sites
0 of 21 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of patients in histological remission
Measured over 6 weeks

Conditions

Eosinophilic Esophagitis

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Eosinophilic Esophagitis

Where it's being run

21 sites across 17 states
California2
Florida2
Michigan2
Ohio2
Arizona1
Arkansas1
Idaho1
Massachusetts1

Study leadership

  • Alfredo J Lucendo, MD, PhD · STUDY_DIRECTOR · Department of Gastroenterology, Hospital General de Tomelloso, Spain

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Signed informed consent,
Male or female patients, 18 to 75 years of age,
Confirmed clinico-pathological diagnosis of eosinophilic esophagitis (EoE) according to established diagnostic criteria
Active symptomatic and histological EoE
Negative pregnancy test in females of childbearing potential at baseline visit.

Exclusion

Clinical and endoscopic signs of gastroesophageal reflux disease (GERD),
Achalasia, scleroderma esophagus, or systemic sclerosis,
Other clinically evident causes than EoE for esophageal eosinophilia,
Any concomitant esophageal disease and relevant gastro-intestinal disease (celiac disease, inflammatory bowel disease, oropharyngeal or esophageal bacterial, viral, or fungal infection \[candida esophagitis\]),
Any relevant systemic disease (e.g., AIDS, active tuberculosis, hepatitis B or C),
If careful medical monitoring is not ensured: cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease, glaucoma, cataract, or infection,
Liver cirrhosis or portal hypertension,
History of cancer in the last five years,
History of esophageal surgery at any time or of esophageal dilation procedures within the last 4 weeks prior to screening visit, or need for an immediate endoscopic intervention due to a stricture
Upper gastrointestinal bleeding within 8 weeks prior to baseline visit,
Existing or intended pregnancy or breast-feeding.

What this trial measures

  • Proportion of patients in histological remission6 weeks

    Histological assessment of biopsies taken at end of treatment visit