Clinical trial NCT00895817: Fluticasone Versus Esomeprazole to Treat Eosinophilic Esophagitis
Official title: Comparison of Aerosolized Swallowed Fluticasone to Esomeprazole for the Treatment of Eosinophilic Esophagitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eosinophilic Esophagitis
Keywords: Eosinophilic esophagitis
acid reflux
Lead sponsor: Walter Reed Army Medical Center
Sponsor class: FED
First posted: 2009-05-08
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants Who Responded
timeFrame: 8 weeks
Secondary outcomes:
measure: Symptom Score
timeFrame: 8 weeks
measure: Endoscopic Change
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
Study officials:
affiliation: Walter Reed Army Medical Center
name: Fouad J Moawad, M.D.
role: PRINCIPAL_INVESTIGATOR
References: