Budesonide Versus Fluticasone for Treatment of Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Intervention: Oral Viscous Budesonide; Fluticasone MDI; Placebo slurry; Placebo inhaler
Intervention description: Oral Viscous Budesonide - 1 mg/4 mL, 4 mL of slurry twice daily; Fluticasone multi-dose inhaler - 4 puffs twice daily (880 mcg, twice daily); Slurry of sucralose - 4 mL twice daily; Placebo inhaler - 4 puffs twice daily
Intervention MeSH terms: Fluticasone; Budesonide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 129.0
Sex: All
Minimum age: 16 Years
Maximum age: 80 Years
Healthy volunteers: No

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
    

Eligibility criteria:

        Inclusion criteria are as follows:

          -  Age: 16 - 80 years

          -  Subject is having a clinically indicated endoscopy for suspicious EoE and has been on
             twice daily (BID) proton pump inhibitor (PPI) for at least 8 weeks OR New diagnosis of
             EoE as per consensus guidelines. 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:

          -  Medical instability that precludes safely performing upper endoscopy

          -  Ongoing or recent symptoms of intestinal bleeding (throwing up blood, passing blood in
             the stool)

          -  Concomitant eosinophilic gastroenteritis

          -  Esophageal narrowing or stricturing that will not allow a standard 9 mm upper
             endoscopy scope to pass

          -  Cancer in the esophagus, stomach, or intestine

          -  Previous esophageal surgery

          -  Esophageal varices (dilated blood vessels in the esophagus)

          -  Current use of blood thinners like Plavix or Coumadin that are not stopped prior to
             endoscopy procedures

          -  Any corticosteroid exposure within the 4 weeks prior to their baseline endoscopic
             exam. Exclusionary corticosteroid exposure is defined as any swallowed topical
             steroids for EoE or systemic steroids for any condition within the four weeks prior to
             the baseline endoscopy. Corticosteroids used for asthma or intranasal corticosteroids
             are not an exclusion and are allowable.

          -  Pregnancy

          -  Inability to read or understand English