Budesonide Versus Fluticasone for Treatment of Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional
Phase: Phase 4

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
    

Detailed description: 
      This will be a prospective, randomized, double-blind, double-dummy, clinical trial comparing
      oral viscous budesonide (OVB) to fluticasone metered dose inhaler (MDI) for treatment of EoE.
      A total of 122 subjects aged 16-80 years old will be randomized in a 1:1 fashion to one of
      two active treatment arms: OVB + placebo inhaler or fluticasone MDI + placebo slurry.

      In the first arm, subjects will be treated with OVB at a dose of 1 mg twice daily, and they
      will also be instructed to use a placebo inhaler identical to the fluticasone MDI, with
      instructions to swallow 4 puffs twice daily. The OVB is a slurry equivalent to what is used
      clinically: 1 mg/4 mL aqueous budesonide mixed with 10 g of sucralose. Rather than asking the
      subjects to mix the slurry on their own and risk inconsistent formulations, the University of
      North Carolina (UNC) investigational drug pharmacy (IDP) will provide pre-mixed OVB to all
      patients. The IDP will also provide placebo inhalers to all patients. The dose for OVB has
      been chosen because it is the most commonly studied dose, including one prior study led by
      this Principal Investigator, so we can accurately estimate response rates.

      In the second arm, subjects will be treated with fluticasone MDI at a dose of 880 mcg twice
      daily (4 puffs of a 220 mcg inhaler twice daily), and they will also be instructed to take 4
      mL twice daily of a placebo slurry of sucralose identical in consistency and taste to the
      OVB. The UNC investigational drug pharmacy (IDP) will provide the fluticasone MDIs and
      pre-mixed placebo slurries to all patients. The dose for fluticasone MDI has been chosen
      because this is the most commonly used dose in adolescents and adults with EoE, so effect
      estimates are also available.

      For both arms, the slurry will be administered first, the MDI will be administered 15 minutes
      later, and patients will take nothing by mouth for an additional 30 minutes.

      Subjects will receive 8 weeks of treatment and will then be monitored for up to 52 weeks for
      recurrence of symptoms.
    

Intervention name(s): Oral Viscous Budesonide; Fluticasone MDI; Placebo slurry; Placebo inhaler
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 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
Other intervention name(s): Pulmicort; Flovent; Sucralose; Placebo
Intervention MeSH terms: Fluticasone; Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment