The Role Of Gastroesophageal Reflux Disease (GERD) in Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis; Gastroesophageal Reflux Disease; EE; GERD
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic; Esophagitis; Eosinophilic Esophagitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The primary aim of this study was to determine the proportion of patients with esophageal
      eosinophilic infiltration that have objective (measurable) evidence of gastroesophageal
      reflux disease (GERD).

      This study was also done to see if patients that have eosinophilic esophagitis (EE) and GERD
      would receive relief from taking the medication Nexium or a steroid called Pulmicort.

      The study also evaluated the accuracy of pH monitoring (acid exposure) within the esophagus
      as a predictor of endoscopic, histological and symptomatic response in patients with EE.
    

Detailed description: 
      Hypotheses:

        1. There is a subset of patients with the diagnosis of EE who also have GERD.

        2. Patients with both EE and GERD will respond symptomatically and histologically to
           aggressive gastric acid suppression with a proton pump inhibitor as monotherapy.

        3. Swallowed budesonide suspension is effective in treating patients with EE who do not
           have evidence of GERD.

      Participants were randomized based on results of a 24 hour pH study, which determined the
      average percent time the distal esophagus was exposed to a pH of less than than 4. Subjects
      with a positive pH result were randomized to esomeprazole or randomized to budesonide, if
      there was a negative pH result. Studies were interpreted by a single gastroenterologist
      experienced in reading esophageal pH studies. The percent time the pH monitor detected a pH
      less than 4 was recorded and an esophageal pH of less than 4 for 4% or greater of the study
      time was considered abnormal. Note: pH is a measure of acidity or alkalinity (lower numbers
      are more acid, higher numbers are more alkaline).

      Those subjects with GERD (positive pH result) received gastric acid-suppressing medication
      (esomeprazole 40 mg, twice daily) for 6 weeks. Subjects who did not have GERD (negative pH
      result) were treated with a corticosteroid designed to coat the esophagus (budesonide
      suspension 1 mg twice daily) for six weeks. Response to treatment was assessed by esophageal
      histology and symptoms.
    

Intervention name(s): Esomeprazole; Budesonide
Intervention type(s): Drug; Drug
Intervention description(s): Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks; Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
Other intervention name(s): Nexium; Pulmicort
Intervention MeSH terms: Budesonide; Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment