Fluticasone Versus Esomeprazole to Treat Eosinophilic Esophagitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fouad J. Moawad, Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT00895817
First received: May 6, 2009
Last updated: March 11, 2013
Last verified: March 2013
  Purpose

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 Intervention
Eosinophilic Esophagitis
Drug: Swallowed fluticasone
Drug: Esomeprazole

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Aerosolized Swallowed Fluticasone to Esomeprazole for the Treatment of Eosinophilic Esophagitis

Resource links provided by NLM:


Further study details as provided by Walter Reed Army Medical Center:

Primary Outcome Measures:
  • Number of Participants Who Responded [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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:
  • Symptom Score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Using a validated questionnaire, symptoms will be assessed at baseline and following therapy.

  • Endoscopic Change [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Following therapy, resolution of EE findings will be assessed.


Enrollment: 42
Study Start Date: April 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00895817

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

No publications provided

Responsible Party: Fouad J. Moawad, Principal Investigator, Walter Reed Army Medical Center
ClinicalTrials.gov Identifier: NCT00895817     History of Changes
Other Study ID Numbers: 08-14045
Study First Received: May 6, 2009
Results First Received: December 28, 2012
Last Updated: March 11, 2013
Health Authority: United States: Federal Government

Keywords provided by 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
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on August 28, 2014