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Comparing once daily and twice daily budesonide for treating eosinophilic esophagitis

Double-blind, Randomized, Non-inferiority Phase III Trial on the Efficacy and Tolerability of 2 mg Once Daily vs. 1 mg Twice Daily Budesonide Orodispersible Tablets in Adults With Eosinophilic Esophagitis

Phase 3 Interventional Dr. Falk Pharma GmbH · NCT06596252

This study is testing whether taking budesonide once a day is just as effective as taking it twice a day for helping adults with eosinophilic esophagitis feel better.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment308 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorDr. Falk Pharma GmbH Industry-sponsored
Locations26 sites (Scottsdale, Arizona and 25 other locations)
Trial IDNCT06596252 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of once daily versus twice daily doses of budesonide orodispersible tablets in inducing remission in adults with eosinophilic esophagitis (EoE). The study will involve a 6-week treatment period where participants will receive either 1 mg or 2 mg of budesonide. The primary goal is to demonstrate that the lower dose is non-inferior to the higher dose in achieving clinico-pathological remission. Participants will be closely monitored for symptoms and histological improvements during the treatment phase.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with a confirmed diagnosis of active eosinophilic esophagitis.

Not a fit: Patients with other gastrointestinal diseases or conditions that could interfere with the study, such as gastroesophageal reflux disease or systemic diseases, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more convenient dosing regimen for patients with eosinophilic esophagitis while maintaining treatment efficacy.

How similar studies have performed: Previous studies have shown promising results with budesonide for eosinophilic esophagitis, suggesting that this approach may be effective.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Scottsdale, Arizona and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Eosinophilic Esophagitis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.