OBS in Adolescent and Adults With EOE: A Phase II, Randomized, Double-Blind, Placebo Controlled, Study With an Open Label Extension

Oral Budesonide Suspension (OBS) in Adolescent and Adult Subjects (11-40 Years of Age)With Eosinophilic Esophagitis: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study With an Open Label Extension

This is a clinical trial to test an experimental drug for the treatment of Eosinophilic Esophagitis (EoE)

Eosinophilic Esophagitis (EoE) is an inflammatory disorder of the esophagus and is a recognized clinical entity. Symptoms include feeding problems, heartburn, regurgitation, vomiting, abdominal pain and food impaction. The symptoms of EoE may be similar to gastroesophageal reflux disease (GERD) but do not resolve with gastric acid suppression. EoE is defined histologically as the presence of > 15 intraepithelial eosinophils per high power fields on one or more esophageal biopsy specimens.

This Phase II study is comparing oral budesonide (OBS) to placebo to demonstrate that OBS induces a histologic response and a symptom response using a Dysphagia Symptom Questionnaire over a 16 week course of therapy.

Inclusion Criteria:

• Males and Females, age 11-40
• Histologic evidence of EoE
• History of clinical symptoms of EoE including dysphagia
• Willing to continue with dietary, environmental or medical therapy
• Ability to read and understand english
• Written Consent

Exclusion Criteria:

• Any Medical condition that may compromise the safety of the subjects or interfere with the signs and symptoms of EoE
• Use of immunomodulatory therapy
• Current use of swallowed corticosteroids
• Esophageal strictures,varices or upper GI bleed
• Other current diseases of the GI tract
• Current viral infection or immunodeficiency condition
• Pregnancy
• Hypersensitivity to budesonide
• History of non compliance