Maintenance of Remission With Budesonide Orodispersible Tablets vs. Placebo in Eosinophilic Esophagitis

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

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.

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.