Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE)

Not Applicable

Completed

• Conditions: Eosinophilic Esophagitis
• Interventions: Drug: inhaled/swallowed budesonide; Drug: viscous/swallowed budesonide

• Registration Number: NCT00961233
• Lead Sponsor: University of North Carolina, Chapel Hill

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 Description

Not available

Study Timeline

• Study First Submitted: 2009-08-14
• Study First Submitted QC: 2009-08-17
• Study First Posted: 2009-08-18
• Study Start: 2009-10
• Primary Completion: 2011-08
• Study Completion: 2011-11
• Results First Submitted: 2012-09-04
• Results First Submitted QC: 2012-10-04
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-02
• Results First Posted: 2012-11-04
• Last Update Posted: 2012-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• New diagnosis of eosinophilic esophagitis (per 2007 consensus guidelines)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
inhaled/swallowed budesonide	inhaled/swallowed budesonide	-
viscous/swallowed budesonide	viscous/swallowed budesonide	-

Primary Outcome Measures

Name	Time	Method
Tissue Eosinophil Counts	8 weeks	Level of tissue eosinophil counts (measured in number of eosinophils per high-power microscopy field) on esophageal biopsy after treatment

Secondary Outcome Measures

Name	Time	Method
Adrenal Insufficiency	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.

Trial Locations

Locations (1)

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States