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Budesonide Versus Fluticasone for Treatment of Eosinophilic Esophagitis

Information source: University of North Carolina, Chapel Hill
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Eosinophilic Esophagitis

Intervention: Oral Viscous Budesonide (Drug); Fluticasone MDI (Drug); Placebo slurry (Drug); Placebo inhaler (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: University of North Carolina, Chapel Hill

Official(s) and/or principal investigator(s):
Evan S Dellon, MD, MPH, Principal Investigator, Affiliation: University of North Carolina, Chapel Hill

Overall contact:
Susan Moist, MPH, Phone: 919-966-7655, Email: susan_moist@med.unc.edu

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 122 16-80 year old patients with a new diagnosis of eosinophilic esophagitis (EoE) who are referred for upper endoscopy. 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

Clinical Details

Official title: Budesonide Versus Fluticasone for Treatment of Eosinophilic Esophagitis

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Histologic effectiveness of viscous budesonide versus fluticasone MDI

Symptomatic effectiveness of viscous budesonide versus fluticasone MDI

Secondary outcome:

Symptom recurrence

Histologic recurrence

Eligibility

Minimum age: 16 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion criteria are as follows:

- Age: 16 - 80 years

- New diagnosis of EoE as per consensus guidelines. 2 Cases must have symptoms of

dysphagia, persistent esophageal eosinophilia (≥ 15 eosinophils in at least one high-power field) after 8 weeks of treatment with a twice daily proton-pump inhibitor, and other competing causes of esophageal eosinophilia excluded. Exclusion criteria are as follows:

- Concomitant eosinophilic gastroenteritis

- Any corticosteroid exposure within the 4 weeks prior to their baseline endoscopic

exam

- Requirement for ongoing inhaled corticosteroid use for treatment of asthma or

pulmonary disease

- Inability to pass a standard 9mm upper endoscope due to esophageal narrowing or

stricturing

- Previous esophageal surgery

- Medical instability that precludes safely performing upper endoscopy

- Inability to read or understand English

- Pregnancy

Locations and Contacts

Susan Moist, MPH, Phone: 919-966-7655, Email: susan_moist@med.unc.edu

University of North Carolina, Chapel Hill, Chapel Hill, North Carolina 27599, United States; Recruiting
Susan Moist, MPH, Phone: 919-966-7655, Email: susan_moist@med.unc.edu
Sarah McGee, Phone: 919-966-4591, Email: smcgee@med.unc.edu
Evan S Dellon, MD, MPH, Principal Investigator
Nicholas Shaheen, MD, MPH, Sub-Investigator
Additional Information

Starting date: October 2014
Last updated: April 20, 2015

Page last updated: August 23, 2015

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