Clinical Trial: Fluticasone Versus Esomeprazole to Treat Eosinophilic Esophagitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Comparison of Aerosolized Swallowed Fluticasone to Esomeprazole for the Treatment of Eosinophilic Esophagitis

Brief Summary:

The purpose of this study is to assess the clinical efficacy of proton pump inhibitors in comparison to aerosolized swallowed steroids for the treatment of eosinophilic esophagitis (EE). EE is an increasingly recognized disorder that has been associated with dysphagia and food impaction. The presence of anatomical abnormalities in the esophagus such as longitudinal furrows, corrugated rings and a narrow caliber esophagus with friable mucosa are classic endoscopic findings. Diagnosis is established with the histologic finding of large numbers (> 15) of eosinophils per high power field. The underlying pathologic mechanism remains poorly understood but food allergies and aeroallergens have been implicated. It is well known that gastroesophageal reflux disease (GERD) may cause esophageal eosinophilia, but it is unclear whether a complex relationship exists between GERD and EE, as recent data suggests. Furthermore, a large number of patients with clinical presentations and endoscopic findings highly suggestive of EE which is confirmed on histology are responding favorably to proton pump inhibitors.

The aims of the study are to (1) compare the clinical efficacy of aerosolized swallowed Fluticasone to Esomeprazole for the treatment of eosinophilic esophagitis, (2) determine whether proton pump inhibitors are effective in the treatment of eosinophilic esophagitis, (3) determine the number of patients with eosinophilic esophagitis that have coexisting gastroesophageal reflux disease, and (4) correlate change in eosinophil count to improvement in symptoms before and after therapy.


Detailed Summary:
Sponsor: Walter Reed Army Medical Center

Current Primary Outcome: Number of Participants Who Responded [ Time Frame: 8 weeks ]

Histologic resolution of esophageal eosinophilia. Response is defined as achieving < 7 eosinophils/high power field in both the proximal and distal esophagus.


Original Primary Outcome: Histologic resolution of esophageal eosinophilia defined as < 7 eosinophils/high power field in both the proximal and distal esophagus. [ Time Frame: 8 weeks ]

Current Secondary Outcome:

  • Symptom Score [ Time Frame: 8 weeks ]
    Using a validated questionnaire, symptoms will be assessed at baseline and following therapy.
  • Endoscopic Change [ Time Frame: 8 weeks ]
    Following therapy, resolution of EE findings will be assessed.


Original Secondary Outcome:

  • Resolution of dysphagia symptoms with therapy using a validated questionnaire. [ Time Frame: 8 weeks ]
  • Endoscopic resolution of EE findings following treatment. [ Time Frame: 8 weeks ]


Information By: Walter Reed Army Medical Center

Dates:
Date Received: May 6, 2009
Date Started: April 2008
Date Completion:
Last Updated: March 11, 2013
Last Verified: March 2013