Maintenance of Remission With Budesonide Orodispersible Tablets vs. Placebo in 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 48-weeks treatment with budesonide orodispersible tablets versus placebo for the maintenance of clinico-pathological remission in patients with eosinophilic esophagitis.

Official Title
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Double-blind, Randomized, Placebo-controlled, Phase III Study on the Efficacy and Tolerability of a 48-week Treatment With Two Different Doses of Budesonide Effervescent Tablets vs. Placebo for Maintenance of Clinico-pathological Remission in Adult Patients With Eosinophilic Esophagitis

Conditions
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Eosinophilic Esophagitis

Intervention / Treatment
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* Drug: Budesonide 0.5mg orodispersible tablet twice daily
* 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 Clinico-pathological remission of 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 baseline 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 0.5mg orodispersible tablet twice daily<br>Budesonide 0.5mg orodispersible tablet twice daily | Drug: Budesonide 0.5mg orodispersible tablet twice daily<br> <br> * Other names: BUL 0.5mg BID;|
| Experimental: Budesonide 1mg orodispersible tablet twice daily<br>Budesonide 1mg orodispersible tablet twice daily | Drug: Budesonide 1mg orodispersible tablet twice daily<br> <br> * Other names: BUL 1mg BID;|
| Placebo Comparator: Placebo orodispersible tablet twice daily<br>Placebo orodispersible tablet twice daily | Drug: Placebo orodispersible tablet twice daily<br> <br> * Other names: Placebo BID;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients free of treatment failure after 48 weeks of treatment. |  | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients with histological relapse |  | 48 weeks | 
| Rate of patients with clinical relapse |  | 48 weeks |