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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
medication will be nebulized and then swallowed
viscous suspension of budesonide will be swallowed
University of North Carolina
Chapel Hill, North Carolina, United States
Tissue Eosinophil Counts
Level of tissue eosinophil counts (measured in number of eosinophils per high-power microscopy field) on esophageal biopsy after treatment
Time frame: 8 weeks
Adrenal Insufficiency
Adrenal insufficiency as measured by a standard cortisol stimulation test (using 0.25 mg cosyntropin IV and baseline and 60 minute post-injection serum cortisol measurements) after treatment. A rise in serum cortisol concentration after to a peak of ≥18 mcg/dL was considered normal; a smaller rise than this was considered adrenal insufficiency.
Time frame: 8 weeks
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