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Completed

NCT Number: NCT00895817

Fluticasone Versus Esomeprazole to Treat Eosinophilic Esophagitis

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Walter Reed Army Medical Center

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Swallowed fluticasone

Drug

440 µg twice daily for 8 weeks

Esomeprazole

Drug

40 mg once daily for 8 weeks

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Walter Reed Army Medical Center

Fed

Registry information

Official study title

Comparison of Aerosolized Swallowed Fluticasone to Esomeprazole for the Treatment of Eosinophilic Esophagitis

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
May 8, 2009
Registry last updated
Mar 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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