Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis

Phase 2

Completed

Brief Summary: This study is designed to evaluate whether or not oral viscous budesonide is effective in treating children with Eosinophilic Esophagitis.

Recruitment & Eligibility

Inclusion Criteria

Histologic evidence of EE defined as greater than 20 eosinophils per hpf on esophageal biopsy
Ages 1 yrs and older
Ability to continue the same diet that the patient was on at the time of EGD with biopsy

Exclusion Criteria

Adverse reaction or allergy to budesonide
Pregnancy
Chronic diseases requiring immunomodulatory therapy
Use of swallowed topical corticosteroids for EE within the past 3 months
Use of systemic steroids 2 months prior to study entry
Upper gastrointestinal bleed within 4 months of study entry
Chronic use of medications that predispose to upper gastrointestinal bleeding including non-steroidal anti-inflammatory medications or anticoagulants
Evidence of adrenal suppression prior to study entry
Evidence of concurrent eosinophilic gastritis, enteritis, colitis, or proctitis
Recent changes in asthma or allergic rhinitis therapy for 3 months

Arm && Interventions

Group	Intervention	Description
2	placebo plus Prevacid	placebo plus Prevacid
1	Budesonide plus Prevacid	oral viscous budesonide plus Prevacid

Primary Outcome Measures

Name	Time	Method
Number of Participants With Improvement of Espohageal Eosinophilia	3 Months	Repeat endoscopy was undertaken using the Olympus P160 endoscope (by RD) at 3 months of treatment.

Secondary Outcome Measures

Name	Time	Method
Upper Gastrointestinal Endoscopy Score	Baseline and 3 Months	Endoscopy scoring tool took into account the following categories: Mucosal pallor/reduced vasculature Linear furrows/mucosal thickening White plaques Concentric rings/stricture Friability/"tissue-paper" mucosa Histology scoring tools Epithelial histology score Peak eosinophil count Each category could score 0-3 for a total maximum score of 15. The higher the score the worse the disease.
Symptom Score	Baseline and 3 Months	Total score was based on the following symptoms: Heartburn/regurgitation Abdominal pain Nausea/vomiting Anorexia/early satiety Dysphagia Symptom induced nocturnal wakening Gastrointestinal bleeding Each symptom could score 0-2 for a maximum score for 14 points. The lower the score the milder the symptoms and the higher the score the more severe symptoms.