Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE

Eligibility 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.
• * 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.