NCT00895817

Fluticasone Versus Esomeprazole to Treat Eosinophilic Esophagitis

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Walter Reed Army Medical Center · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Eosinophilic Esophagitis

Interventions

Type	Name	Description
DRUG	Swallowed fluticasone	440 µg twice daily for 8 weeks
DRUG	Esomeprazole	40 mg once daily for 8 weeks

Timeline

• Start date: 2008-04-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2009-05-08
• Last updated: 2013-03-12
• Results posted: 2013-03-12

Locations

1 site across 1 country: United States