Clinical Trial: Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE): Esophageal Medication Distribution, Treatment Response, and Effect on the Adrenal Axis.

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.

Detailed Summary:
Sponsor: University of North Carolina, Chapel Hill

Current Primary Outcome: 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


Original Primary Outcome: The primary endpoints are: 1) percent decrease in tissue eosinophil counts; and 2) absolute improvement on dysphagia symptom scores. [ Time Frame: 8 weeks ]

Current Secondary Outcome: Adrenal Insufficiency [ Time Frame: 8 weeks ]

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.


Original Secondary Outcome: The secondary endpoints are: 1) Cortisol stimulation test results and adrenocorticotropic hormone levels; and 2) Serum budesonide screen results. [ Time Frame: 8 weeks ]

Information By: University of North Carolina, Chapel Hill

Dates:
Date Received: August 14, 2009
Date Started: October 2009
Date Completion:
Last Updated: November 2, 2012
Last Verified: November 2012