Fluticasone Versus Esomeprazole to Treat Eosinophilic Esophagitis
Status:
Completed
Trial end date:
2010-10-01
Target enrollment:
Participant gender:
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.