Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis

Sponsor

University of Utah (Other)

Overall Status

Completed

CT.gov ID

NCT00123656

Collaborator

American Society for Gastrointestinal Endoscopy (Other)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Esophagitis	Drug: esomeprazole Drug: fluticasone	Phase 2

Detailed Description

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 esomeprazole 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis

Study Start Date :

Aug 1, 2004

Actual Primary Completion Date :

Dec 1, 2006

Actual Study Completion Date :

Dec 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 fluticasone	Drug: fluticasone fluticasone dosed 220 mcg 2 puffs swallowed BID for 8 weeks Other Names: Flovent
Active Comparator: 2 esomeprazole	Drug: esomeprazole esomeprazole dosed qam for 8 weeks Other Names: Nexium

Arm

Intervention/Treatment

Active Comparator: 1

fluticasone

Drug: fluticasone

fluticasone dosed 220 mcg 2 puffs swallowed BID for 8 weeks

Other Names:

Flovent

Active Comparator: 2

esomeprazole

Drug: esomeprazole

esomeprazole dosed qam for 8 weeks

Other Names:

Nexium

Outcome Measures

Primary Outcome Measures

To measure change in eosinophil infiltration and degranulation at 8 weeks in response to treatment of allergy versus treatment for GER in EE patients [8 weeks]

Secondary Outcome Measures

To assess change in dysphagia score, GERD symptoms, allergy/atopy at 8 weeks using validated questionnaires [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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