Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE)
Information source: The University of North Carolina, Chapel Hill
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Eosinophilic Esophagitis
Intervention: inhaled/swallowed budesonide (Drug); viscous/swallowed budesonide (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: The University of North Carolina, Chapel Hill Official(s) and/or principal investigator(s):
Evan S Dellon, MD, MPH, Principal Investigator, Affiliation: UNC
Overall contact:
Courtney Ziefle, Phone: 919-966-4591, Email: cziefle@med.unc.edu
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.
Clinical Details
Official title: Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE): Esophageal Medication Distribution, Treatment Response, and Effect on the Adrenal Axis.
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The primary endpoints are: 1) percent decrease in tissue eosinophil counts; and 2) absolute improvement on dysphagia symptom scores.
Secondary outcome: The secondary endpoints are: 1) Cortisol stimulation test results and adrenocorticotropic hormone levels; and 2) Serum budesonide screen results.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Courtney Ziefle, Phone: 919-966-4591, Email: cziefle@med.unc.edu
University of North Carolina, Chapel Hill, North Carolina 27599, United States
Additional Information
Starting date: October 2009
Ending date: September 2010
Last updated: August 17, 2009
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