Fluticasone Versus Esomeprazole to Treat Eosinophilic Esophagitis

• ClinicalTrials.gov Identifier: NCT00895817
• Recruitment Status: Completed
• First Posted: May 8, 2009
• Results First Posted: March 12, 2013
• Last Update Posted: March 12, 2013
• Sponsor: Walter Reed Army Medical Center
• Information provided by (Responsible Party): Fouad J. Moawad, Walter Reed Army Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Eosinophilic Esophagitis	Drug: Swallowed fluticasone; Drug: Esomeprazole	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Comparison of Aerosolized Swallowed Fluticasone to Esomeprazole for the Treatment of Eosinophilic Esophagitis
• Study Start Date: April 2008
• Actual Primary Completion Date: October 2010
• Actual Study Completion Date: October 2010

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Swallowed fluticasone	Drug: Swallowed fluticasone; 440 µg twice daily for 8 weeks
Active Comparator: Esomeprazole	Drug: Esomeprazole; 40 mg once daily for 8 weeks

Outcome Measures

Primary Outcome Measures :

1. Number of Participants Who Responded [ Time Frame: 8 weeks ]
   Histologic resolution of esophageal eosinophilia. Response is defined as achieving < 7 eosinophils/high power field in both the proximal and distal esophagus.

Secondary Outcome Measures :

1. Symptom Score [ Time Frame: 8 weeks ]
   Using a validated questionnaire, symptoms will be assessed at baseline and following therapy.
2. Endoscopic Change [ Time Frame: 8 weeks ]
   Following therapy, resolution of EE findings will be assessed.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, District of Columbia

Walter Reed Army Medical Center

Washington, District of Columbia, United States, 20307

Sponsors and Collaborators

Walter Reed Army Medical Center

Investigators

• Principal Investigator: Fouad J Moawad, M.D.; Walter Reed Army Medical Center

More Information

• Responsible Party: Fouad J. Moawad, Principal Investigator, Walter Reed Army Medical Center
• ClinicalTrials.gov Identifier: NCT00895817
• Other Study ID Numbers: 08-14045
• First Posted: May 8, 2009
• Results First Posted: March 12, 2013
• Last Update Posted: March 12, 2013
• Last Verified: March 2013

Keywords provided by Fouad J. Moawad, Walter Reed Army Medical Center:

Eosinophilic esophagitis; acid reflux

Additional relevant MeSH terms:

Esophagitis; Eosinophilic Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Fluticasone; Esomeprazole; Anti-Inflammatory Agents; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Dermatologic Agents; Anti-Allergic Agents; Anti-Ulcer Agents; Gastrointestinal Agents; Proton Pump Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action