Fluticasone Versus Esomeprazole to Treat Eosinophilic Esophagitis

NCT ID: NCT00895817

Last Updated: 2013-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2010-10-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Swallowed fluticasone

Group Type: ACTIVE_COMPARATOR

Swallowed fluticasone

Intervention Type: DRUG

440 µg twice daily for 8 weeks

Esomeprazole

Group Type: ACTIVE_COMPARATOR

Esomeprazole

Intervention Type: DRUG

40 mg once daily for 8 weeks

Interventions

Swallowed fluticasone

440 µg twice daily for 8 weeks

Intervention Type: DRUG

Esomeprazole

40 mg once daily for 8 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with an established diagnosis of EE defined as > 20 eosinophils/HPF in the setting of dysphagia or food impaction.
• Males and females age > 18 years of age.
• Ability to undergo ambulatory pH monitoring.
• DEERS (Defense Enrollment Eligibility Reporting System) eligible.
• Willingness to take a one month holiday from a PPI or steroids if they have been prescribed this prior to enrollment.
• Willingness to participate and have additional biopsies taken during endoscopy and answer a questionnaire.

Exclusion Criteria

• Patients < 18 years of age.
• Inability to give consent.
• Inability to undergo endoscopy or contraindications to endoscopy. Any medical condition or disorder (including drug allergies), which would preclude the use of conscious sedation or the ability to tolerate upper endoscopy.
• Contraindications to proton pump inhibitors or steroids.
• Inability to accurately fill out a short questionnaire.
• Pregnant females. A urine beta human chorionic gonadotropin (BHCG) prior to endoscopy will be offered to all female patients of child bearing potential (exceptions include post-menopausal, hysterectomy or bilateral tubal ligation). Positive BHCG results will prevent enrollment.
• Known coagulation abnormalities, thrombocytopenia and patients on coumadin.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Walter Reed Army Medical Center

FED

Sponsor Role: lead

Responsible Party

Fouad J. Moawad

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fouad J Moawad, M.D.

Role: PRINCIPAL_INVESTIGATOR

Walter Reed Army Medical Center

Locations

Walter Reed Army Medical Center

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

08-14045

Identifier Type: -

Identifier Source: org_study_id