Budesonide Orodispersible Tablet vs. Placebo in Active Eosinophilic Esophagitis

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.