Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE)

University of North Carolina (UNC)

Status: Completed

Conditions: Eosinophilic Esophagitis

Treatments: Drug: viscous/swallowed budesonide; Drug: inhaled/swallowed budesonide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00961233

IRUSESOM0609

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

inhaled/swallowed budesonide

Experimental group

Treatment:

Drug: inhaled/swallowed budesonide

viscous/swallowed budesonide

Active Comparator group

Treatment:

Drug: viscous/swallowed budesonide