The purpose of this study is to prove the non-inferiority of a 6-weeks treatment with 1 mg budesonide orodispersible tablets BID versus 2 mg budesonide orodispesible tabletss for the induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis.
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
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]),
Sequential
Budesonide
DrugTwice daily intake of the tablet 30 min after a meal
Proportion of patients in histological remission
Histological assessment of biopsies taken at end of treatment visit
Proportion of patients in clinical remission
Assessment of clinical scores assessed with questionnaires at the end of treatment visit
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