Eosinophilic esophagitis (EE) is a recently recognized entity. It has been thought to be either an allergic manifestation or an atypical manifestation of reflux. There have been reports of efficacy of both swallowed, aerosolized steroids and proton pump inhibitors in its treatment. We propose to directly compare the efficacy of aerosolized fluticasone to esomeprazole in the treatment of eosinophilic esophagitis. Patients will undergo endoscopy, pH monitoring and manometry for diagnosis. Following diagnosis of EE, patients will be randomized to esomeprazole or swallowed fluticasone for 8 weeks. At the end of 8 weeks, subjects will be asked to repeat manometry/pH and upper endoscopy with biopsies. Three questionnaires (dysphagia, GERD, and allergy) will be completed by the patient at baseline and study end. The primary objective is to measure change in eosinophil infiltration and degranulation in response to treatment of allergy versus treatment for GER in EE patients.

Condition	Intervention	Phase
Esophagitis	Drug: esomeprazole  Drug: fluticasone	Phase II

Further Study Details: 

Primary Outcomes: To measure change in eosinophil infiltration and degranulation at 8 weeks in response to treatment of allergy versus treatment for GER in EE patients
Secondary Outcomes: To assess change in dysphagia score, GERD symptoms, allergy/atopy at 8 weeks using valudated questionnaires
Expected Total Enrollment:  30

This is a randomized, non-blinded, multicenter treatment trial to demonstrate and compare the efficacy of esomeprazole and fluticasone in the treatment of eosinophilic esophagitis. Following the initial diagnostic EGD with four quadrant biopsy, serum eosinophil count and serum IgE levels will be measured. Patients will undergo 24 hour pH study to determine the incidence of reflux in this population. Clinical assessment will be performed with validated questionnaires quantifying dysphagia, GERD, and allergy/atopy. Patients will be randomized to 8 weeks of either esomerazole versus swallowed aerosolized fluticasone. After 8 weeks of therapy, upper endoscopy will again be performed. Eosinophils per high power field will be quantified, and biopsies will be stained for major basic protein. Dysphagia, GERD, and allergy/atopy questionnaires will be repeated, as will serum eosinophil counts and IgE measurements.

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Patients aged 18-80 with EE, defined as: a) dysphagia, food impaction or other upper gastrointestinal symptoms (chest pain, heartburn, regurgitation) b)multiple esophageal rings or furrows c)the presence of >20 eosinophils/high power field in the squamous epithelium or deeper tissues of the esophagus
• Ability to undergo esophageal manometry and ambulatory pH monitoring
• No history of bleeding diathesis, significant cardiopulmonary disease, or other contraindication to upper endoscopy
• Those who have had a one month holiday from either esomeprazole therapy or fluticasone if they have been prescribed this prior to enrollment

Exclusion Criteria:

• Contraindication to proton pump inhibitors or swallowed fluticasone
• Need for immediate esophageal dilation at enrollment due to food impaction at the discretion of the performing endoscopist
• Inability to pass endoscope
• Pregnancy
• Incarceration
• Inability to provide informed consent
• History of esophago-gastric surgery or prior history of abdominal surgery with subsequent strictures or symptoms of obstruction such as abdominal pain and bloating
• Presence of other esophageal pathology that could account for patients'''' symptoms as determined by histological interpretation by the pathologist
• History of esophageal spasm resulting in trouble swallowing foods larger than 1 cm in diameter

Please refer to this study by ClinicalTrials.gov identifier  NCT00123656

Kristen Hilden, M.S.      801-581-3693    kristen.hilden@hsc.utah.edu

Utah
      University of Utah HSC, Salt Lake City,  Utah,  84132,  United States; Recruiting

Study chairs or principal investigators

John C. Fang, M.D.,  Principal Investigator,  University of Utah HSC   

Study ID Numbers:  12790
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 22, 2005
ClinicalTrials.gov Identifier:  NCT00123656
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-07-26