Topical Steroid Treatment for Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a randomized controlled trial of swallowed fluticasone vs. placebo for eosinophilic
      esophagitis. Eosinophilic esophagitis is an inflammatory condition in which the wall of the
      esophagus becomes filled with large numbers of eosinophils, a type of white blood cell.
      Patients who have this condition have difficulty in swallowing (dysphagia) solid food.

      Prior to treatment the patients had biopsies of their esophagus and took questionnaires
      regarding their symptoms. Treatment was given for 6 weeks, after which biopsies were taken
      from the esophagus to measure any changes in the tissue from before treatment. The primary
      endpoint was improvement in dysphagia as measured by the validated Mayo Dysphagia
      Questionaire. Secondary outcomes included partial symptom response, and histologic (tissue)
      response to treatment.
    

Detailed description: 
      This was a double-blind randomized placebo controlled trial to evaluate the effect of
      aerosolized fluticasone therapy on symptomatic dysphagia and histologic eosinophilia in
      adults newly diagnosed with eosinophilic esophagitis (EoE). Participants were randomized to
      receive aerosolized swallowed fluticasone 880 mcg bid or placebo inhaler swallowed bid for 6
      weeks.

      Four mid esophageal biopsies were obtained from 10 cm above the squamo-columnar junction;
      then formalin-fixed and stained with hematoxylin and eosin. All esophageal biopsies were read
      and scored by a single expert gastrointestinal pathologist. The formalin-fixed
      paraffin-embedded esophageal biopsies were retrieved and underwent standard major basic
      protein (MBP) immunofluorescence staining. All special stain slides were then read and scored
      by another pathologist. 24-hour urine was collected for free cortisol by the standard
      technique. The original endoscopy was performed before the patient was enrolled in the trial
      by standard clinical technique. The endoscopy post treatment was done in the clinical
      research unit by the principal investigator.

      Patients kept compliance logs that were reviewed at phone interviews at 2 and 4 weeks time
      and at the end of study evaluation. Ninety percent compliance was required for study
      inclusion.

      At the end of 6 weeks, a 24-hour urine cortisol was done, and patients underwent a repeat
      endoscopy while still on treatment. Mid-esophageal biopsies were obtained and evaluated for
      eosinophil density and mast cell degranulation. At this visit the patients returned dysphagia
      and side effects questionnaires.
    

Intervention name(s): Fluticasone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Aerosolized swallowed fluticasone 880 mg twice a day; Placebo inhaler swallowed twice a day for 6 weeks
Other intervention name(s): Flonase; Veramyst
Intervention MeSH terms: Fluticasone
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Eosinophilic Esophagitis; Fluticasone; Dysphagia