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Budesonide Versus Fluticasone for Treatment of Eosinophilic Esophagitis

NCT02019758 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2020-04-27

Study results available
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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

Conditions

  • Eosinophilic Esophagitis

Interventions

DRUG

Oral Viscous Budesonide

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

DRUG

Fluticasone MDI

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

DRUG

Placebo slurry

Slurry of sucralose - 4 mL twice daily

DRUG

Placebo inhaler

Placebo inhaler - 4 puffs twice daily

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Evan S Dellon, MD, MPH · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-01
Primary Completion
2018-05-31
Completion
2019-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02019758 on ClinicalTrials.gov