Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis

Ranjan Dohil

Status and phase: Completed; Phase 2

Conditions: Eosinophilic Esophagitis

Treatments: Drug: placebo plus Prevacid; Drug: Budesonide plus Prevacid

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00638456

VPI-106-01

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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32 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

oral viscous budesonide plus Prevacid

Treatment:

Drug: Budesonide plus Prevacid

2

Placebo Comparator group

Description:

placebo plus Prevacid

Treatment:

Drug: placebo plus Prevacid