N/A
Completed N=25
Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE)
Source: ClinicalTrials.gov NCT00961233 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Nov 2012
Primary outcomePrimary: Tissue Eosinophil Counts — 89; 11 # of eosinophils per high-power field
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tissue Eosinophil Counts |
89; 11 | — |
| SECONDARY Adrenal Insufficiency |
0; 0 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00961233). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.