Budesonide Orodispersible Tablet vs. Placebo in Active Eosinophilic Esophagitis

Study Overview
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Brief Summary
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The purpose of this study is to prove the superiority of a 6-weeks treatment with budesonide effervescent tablets versus placebo for the induction of clinico-pathological remission in patients with acute eosinophilic esophagitis.

Official Title
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Double-blind, Randomized, Placebo-controlled, Phase III Trial on the Efficacy and Tolerability of a 6-week Treatment With Budesonide Effervescent Tablets vs. Placebo for Induction of Clinico-pathological Remission in Adult Patients With Active Eosinophilic Esophagitis

Conditions
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Eosinophilic Esophagitis

Intervention / Treatment
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* Drug: Budesonide 1mg orodispersible tablet twice daily
* Drug: Placebo orodispersible tablet twice daily


Participation Criteria
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Eligibility Criteria
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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, A documented trial with proton pump inhibitors (PPIs) in order to rule out PPI-responsive esophageal eosinophilia, Negative pregnancy test in females of childbearing potential at baseline visit. Exclusion Criteria: Clinical and endoscopic signs of gastroesophageal reflux disease (GERD), History of abnormal results in case of an optionally performed pH-monitoring of the distal esophagus, Patients with PPI-responsive esophageal eosinophilia 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), 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 8 weeks prior to screening visit, Upper gastrointestinal bleeding within 8 weeks prior to screening visit, Existing or intended pregnancy or breast-feeding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Budesonide<br>Budesonide 1mg orodispersible tablet twice daily | Drug: Budesonide 1mg orodispersible tablet twice daily<br> <br> |
| Placebo Comparator: Placebo<br>Placebo orodispersible tablet twice daily | Drug: Placebo orodispersible tablet twice daily<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of clinico-pathological remission |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients with histological remission |  | 6 weeks | 
| Rate of patients with resolutions of symptoms measured by numerical rating score of symptoms |  | week 6 |