Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE): Esophageal Medication Distribution, Treatment Response, and Effect on the Adrenal Axis.
Overview
- Phase
- N/A
- Intervention
- inhaled/swallowed budesonide
- Conditions
- Eosinophilic Esophagitis
- Sponsor
- University of North Carolina, Chapel Hill
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Tissue Eosinophil Counts
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The purpose of this study is to conduct a clinical trial of two formulations of budesonide (nebulized/swallowed versus viscous/swallowed) in patients with EoE to determine if medication contact time and distribution in the esophagus relates to treatment response. The investigators will also determine if there is systemic absorption of these topical steroids. The investigators hypothesize that tissue and symptom response will correlate with esophageal medication contact time and distribution, and that significant systemic absorption will not be seen.
Investigators
Evan Dellon
MD, MPH
University of North Carolina, Chapel Hill
Eligibility Criteria
Inclusion Criteria
- •New diagnosis of eosinophilic esophagitis (per 2007 consensus guidelines)
Exclusion Criteria
- •Age \< 18
- •Inability to read or understand English
- •Pregnant or nursing women
- •Previous allergic reactions to steroid medications
- •Current use of systemic steroids
Arms & Interventions
inhaled/swallowed budesonide
Intervention: inhaled/swallowed budesonide
viscous/swallowed budesonide
Intervention: viscous/swallowed budesonide
Outcomes
Primary Outcomes
Tissue Eosinophil Counts
Time Frame: 8 weeks
Level of tissue eosinophil counts (measured in number of eosinophils per high-power microscopy field) on esophageal biopsy after treatment
Secondary Outcomes
- Adrenal Insufficiency(8 weeks)