Fluticasone Versus Esomeprazole to Treat Eosinophilic Esophagitis

NCT00895817 | Completed Results DMC

• 1 other identifier: 08-14045
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Keywords

Eosinophilic esophagitis; acid reflux

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Responded

  Histologic resolution of esophageal eosinophilia. Response is defined as achieving \< 7 eosinophils/high power field in both the proximal and distal esophagus.

  8 weeks

Secondary Outcomes (2)

• Symptom Score

  8 weeks

• Endoscopic Change

  8 weeks

Study Arms (2)

Swallowed fluticasone

ACTIVE COMPARATOR

Drug: Swallowed fluticasone

Esomeprazole

ACTIVE COMPARATOR

Drug: Esomeprazole

Interventions

Swallowed fluticasone DRUG

440 µg twice daily for 8 weeks

Swallowed fluticasone

Esomeprazole DRUG

40 mg once daily for 8 weeks

Esomeprazole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Walter Reed Army Medical Center: lead

Study Sites (1)

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

Location

MeSH Terms

Conditions

Eosinophilic Esophagitis; Gastroesophageal Reflux

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Esophageal Motility Disorders; Deglutition Disorders

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Fouad J Moawad
• Organization: Walter Reed Army Medical Center

fouad.moawad@us.army.mil

(301) 295-4600

Study Officials

• Fouad J Moawad, M.D.

  Walter Reed Army Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 6, 2009
• First Posted: May 8, 2009
• Study Start: April 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: March 12, 2013
• Results First Posted: March 12, 2013

Record last verified: 2013-03

Locations

US (1)