CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 129 enrolled
Drug / intervention
Oral Viscous Budesonide +3 moredrug
Likely dose
Oral Viscous Budesonide 1 mgfrom 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/NCT02019758
NCT02019758Phase 4Completed
CompareCT.gov

Budesonide Versus Fluticasone for Treatment of Eosinophilic Esophagitis

University of North Carolina, Chapel Hill·interventional·Posted Dec 24, 2013·Updated Apr 27, 2020

In Brief

A Phase 4 clinical trial evaluating Oral Viscous Budesonide, Fluticasone MDI, and 2 other interventions for Eosinophilic Esophagitis. Completed, enrolled 129 participants across 1 site.

Detailed Summary

Purpose: To determine whether oral viscous budesonide (OVB) or fluticasone metered dose inhaler (MDI) most effectively treats EoE by improving histologic findings and symptoms, which medication provides a more durable treatment response, and whether biomarkers can predict treatment response. Participants: A total of up to 200 16-80 year old patients with a new diagnosis of eosinophilic esophagitis (EoE) who are referred for upper endoscopy will be consented with a target of 122 randomized. Procedures: This will be a prospective, randomized, double-blind, double-dummy, clinical trial comparing OVB to fluticasone MDI for treatment of EoE. This overall study design will generate data for all three Aims

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEosinophilic Esophagitis
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 24, 2013
Enrollment StartJan 1, 2015
Primary CompletionMay 1, 2018
Study CompletionApr 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 12.5 years ago

Interventions

Oral Viscous Budesonidedrug

Oral Viscous Budesonide - 1 mg/4 mL, 4 mL of slurry twice daily

Fluticasone MDIdrug

Fluticasone multi-dose inhaler - 4 puffs twice daily (880 mcg, twice daily)

Placebo slurrydrug

Slurry of sucralose - 4 mL twice daily

Placebo inhalerdrug

Placebo inhaler - 4 puffs twice daily