Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis

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

Official Title
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Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis, a Randomized Clinical Trial

Conditions
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Eosinophilic Esophagitis

Intervention / Treatment
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* Drug: Budesonide plus Prevacid
* Drug: placebo plus Prevacid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>oral viscous budesonide plus Prevacid | Drug: Budesonide plus Prevacid<br>* Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months.<br>|
| Placebo Comparator: 2<br>placebo plus Prevacid | Drug: placebo plus Prevacid<br>* Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Improvement of Espohageal Eosinophilia | Repeat endoscopy was undertaken using the Olympus P160 endoscope (by RD) at 3 months of treatment. | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper Gastrointestinal Endoscopy Score | 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. | Baseline and 3 Months | 
| Symptom Score | 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. | Baseline and 3 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eosinophils, Esophagitis, Microscopy