CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 25 enrolled
Drug / intervention
inhaled/swallowed budesonide +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00961233
NCT00961233N/ACompleted

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

University of North Carolina, Chapel Hill·interventional·Posted Aug 18, 2009·Updated Nov 6, 2012

In Brief

A clinical study evaluating inhaled/swallowed budesonide and viscous/swallowed budesonide for Eosinophilic Esophagitis. Completed, enrolled 25 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsAstraZeneca

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 18, 2009
Enrollment StartOct 1, 2009
Primary CompletionAug 1, 2011
Study CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.9 years ago

Interventions

inhaled/swallowed budesonidedrug

medication will be nebulized and then swallowed

viscous/swallowed budesonidedrug

viscous suspension of budesonide will be swallowed