Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruitingRare disease

Study on Budesonide Tablets for Treating Eosinophilic Esophagitis in Adults

Fast replyRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of eosinophilic esophagitis, a condition where the esophagus becomes inflamed due to a high number of eosinophils, which are a type of white blood cell. The study is testing the effectiveness and tolerability of budesonide orodispersible tablets, which are designed to dissolve in the mouth. The trial compares two dosing schedules: taking 2 mg once daily versus 1 mg twice daily. The goal is to determine if the once-daily dose is as effective as the twice-daily dose in achieving histological remission, which means reducing the inflammation in the esophagus to a level that is not detectable under a microscope.

Participants in the study will be randomly assigned to one of the two dosing schedules. The study is designed to be double-blind, meaning neither the participants nor the researchers will know which dosing schedule each participant is following. This helps ensure that the results are not biased. The trial will last for a period of six weeks, during which the participants will take the medication and undergo various assessments to monitor their condition and any changes in symptoms.

The primary focus of the study is to see how many participants achieve histological remission. Secondary aspects being observed include changes in the severity of symptoms such as difficulty swallowing (dysphagia) and pain when swallowing (odynophagia), as well as overall symptom severity. The study aims to provide valuable information on the best dosing schedule for treating eosinophilic esophagitis with budesonide orodispersible tablets.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient must provide a signed informed consent.

    Eligibility includes being between 18 to 75 years old, having a confirmed diagnosis of eosinophilic esophagitis (EoE), and experiencing active symptoms.

    The patient must have at least 4 points in the Patient's Global Assessment concerning the severity of EoE symptoms at the baseline visit.

  2. Step 2

    Medication administration

    The patient will receive budesonide orodispersible tablets.

    The study compares two dosing regimens: 2 mg once daily versus 1 mg twice daily.

    The medication is taken orally.

  3. Step 3

    Treatment duration

    The treatment aims to induce histological remission in patients with active EoE.

    The primary goal is to assess the proportion of patients achieving histological remission.

  4. Step 4

    Monitoring and assessment

    The study will monitor changes in the peak eosinophil count from baseline to week 6.

    Other assessments include changes in the severity of swallowing difficulties and overall EoE symptoms.

    The total weekly Eosinophilic Esophagitis Activity Index will also be evaluated.

  5. Step 5

    Study completion

    The estimated end date for the study is April 1, 2025.

    The study aims to demonstrate the same clinical efficacy and tolerability of the two dosing regimens.

Who can join the trial?

5 criteria

  • Must have signed an informed consent form, which means you agree to participate in the study after understanding all the details.
  • Must be a man or woman between the ages of 18 and 75 years old.
  • Must have a confirmed diagnosis of eosinophilic esophagitis (EoE), a condition where a type of white blood cell called eosinophil builds up in the esophagus, causing inflammation.
  • Must have active symptoms and histological EoE, meaning the condition is currently causing symptoms and can be seen in tissue samples under a microscope.
  • Must score at least 4 points in the Patient's Global Assessment (PatGA), which is a way to measure how severe your EoE symptoms are at the start of the study.

Who cannot join the trial?

3 criteria

  • Patients who are not adults cannot participate. This means only individuals who are 18 years or older can join.
  • Patients who do not have a diagnosis of eosinophilic esophagitis cannot participate. This is a condition where a type of white blood cell called eosinophil builds up in the esophagus, which is the tube that carries food from the mouth to the stomach.
  • Patients who are part of a vulnerable population cannot participate. This generally refers to groups who may need special protection, like children or people with certain disabilities.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Budesonide Orodispersible Tablets are used in this clinical trial to help treat adults with eosinophilic esophagitis, a condition where the esophagus becomes inflamed due to an increase in eosinophils, a type of white blood cell. These tablets dissolve in the mouth and are designed to reduce inflammation in the esophagus, helping to achieve histological remission, which means reducing the number of eosinophils to a normal level. The trial is comparing two different dosing schedules to see if they are equally effective and well-tolerated by patients.

What is already known about the treatment

Budesonide – Budesonide is administered in the form of orodispersible tablets, which dissolve in the mouth for easy application. It is currently being studied in a phase III clinical trial to assess its effectiveness and tolerability in treating eosinophilic esophagitis, a condition characterized by inflammation of the esophagus. The main therapeutic indication for budesonide in this trial is to induce histological remission in adults with active eosinophilic esophagitis. At the molecular level, budesonide works by reducing inflammation through its action as a corticosteroid, which decreases the activity of the immune system. It is classified pharmacologically as a glucocorticoid.

Investigated diseases

Eosinophilic Esophagitis – Eosinophilic esophagitis is a chronic immune system disease where a type of white blood cell, called eosinophil, builds up in the lining of the esophagus. This accumulation is often a reaction to foods, allergens, or acid reflux and can lead to inflammation. Over time, the inflammation can cause the esophagus to become narrow, leading to difficulty swallowing and food getting stuck. Symptoms may include heartburn, chest pain, and a feeling of food being stuck in the throat. The condition can vary in severity, with some individuals experiencing mild symptoms and others having more significant difficulties. It is considered a rare disease and requires ongoing management to control symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515229-26-00Protocol codeBUL-8/EEAEstimated enrolment308 patientsSponsorDr. Falk Pharma GmbH

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.