Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis
Status:
Completed
Trial end date:
2006-12-01
Target enrollment:
Participant gender:
Summary
Eosinophilic esophagitis (EE) is a recently recognized entity. It has been thought to be
related to both allergies and acid reflux. There have been reports that both swallowed,
aerosolized steroids and proton pump inhibitors have been effective treatments. The
researchers propose to directly compare the efficacy of aerosolized fluticasone to
esomeprazole in the treatment of eosinophilic esophagitis. The hypothesis is that aerosolized
fluticasone (Flovent) will be more effective in relieving symptoms of EE than esomeprazole
(Nexium) treatment. Patients will undergo endoscopy, pH monitoring and manometry for
diagnosis. Following diagnosis of EE by pathology (biopsy of esophagus), patients will be
randomized to esomeprazole or swallowed fluticasone for 8 weeks. At the end of 8 weeks,
subjects will be asked to repeat upper endoscopy with biopsies. Three questionnaires
(dysphagia, gastroesophageal reflux disease [GERD], and allergy) will be completed by the
patient at the first endoscopy and at the end endoscopy. The primary objective is to measure
change in eosinophil infiltration of the esophagus in response to treatment of allergy
(swallowed fluticasone) versus treatment for reflux (esomeprazole) in EE patients.