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 MDISymptomatic effectiveness of viscous budesonide versus fluticasone MDI
Secondary outcome: Symptom recurrenceHistologic 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
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