Title
Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis
Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis, a Randomized Clinical Trial
Phase
Phase 2Lead Sponsor
University of California, San DiegoStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Eosinophilic EsophagitisIntervention/Treatment
budesonide lansoprazole ...Study Participants
32This study is designed to evaluate whether or not oral viscous budesonide is effective in treating children with Eosinophilic Esophagitis.
Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
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
| Event Type | Organ System | Event Term | Oral Viscous Budesonide Plus Prevacid | Placebo Plus Prevacid |
|---|
Repeat endoscopy was undertaken using the Olympus P160 endoscope (by RD) at 3 months of treatment.
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.
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.
