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Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis

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ClinicalTrials.gov Identifier: NCT00123656
Recruitment Status : Completed
First Posted : July 25, 2005
Last Update Posted : January 16, 2008
Sponsor:
Collaborator:
American Society for Gastrointestinal Endoscopy
Information provided by:
University of Utah

Study Description
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Brief Summary:
Eosinophilic esophagitis (EE) is a recently recognized entity. It has been thought to be related to both allergies and acid reflux. There have been reports that both swallowed, aerosolized steroids and proton pump inhibitors have been effective treatments. The researchers propose to directly compare the efficacy of aerosolized fluticasone to esomeprazole in the treatment of eosinophilic esophagitis. The hypothesis is that aerosolized fluticasone (Flovent) will be more effective in relieving symptoms of EE than esomeprazole (Nexium) treatment. Patients will undergo endoscopy, pH monitoring and manometry for diagnosis. Following diagnosis of EE by pathology (biopsy of esophagus), patients will be randomized to esomeprazole or swallowed fluticasone for 8 weeks. At the end of 8 weeks, subjects will be asked to repeat upper endoscopy with biopsies. Three questionnaires (dysphagia, gastroesophageal reflux disease [GERD], and allergy) will be completed by the patient at the first endoscopy and at the end endoscopy. The primary objective is to measure change in eosinophil infiltration of the esophagus in response to treatment of allergy (swallowed fluticasone) versus treatment for reflux (esomeprazole) in EE patients.

Condition or disease Intervention/treatment Phase
Esophagitis Drug: esomeprazole Drug: fluticasone Phase 2

Detailed Description:

This is a randomized, non-blinded, multicenter treatment trial to demonstrate and compare the efficacy of esomeprazole and fluticasone in the treatment of eosinophilic esophagitis.

Following the initial diagnostic EGD with four quadrant biopsy, serum eosinophil count and serum IgE levels will be measured. Patients will undergo 24 hour pH study to determine the incidence of reflux in this population. Clinical assessment will be performed with validated questionnaires quantifying dysphagia, GERD, and allergy/atopy. Patients will be randomized to 8 weeks of either esomeprazole versus swallowed aerosolized fluticasone. After 8 weeks of therapy, upper endoscopy will again be performed. Eosinophils per high power field will be quantified, and biopsies will be stained for major basic protein. Dysphagia, GERD, and allergy/atopy questionnaires will be repeated, as will serum eosinophil counts and IgE measurements.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis
Study Start Date : August 2004
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
fluticasone
 Drug: fluticasone
fluticasone dosed 220 mcg 2 puffs swallowed BID for 8 weeks
Other Name: Flovent
Active Comparator: 2
esomeprazole
 Drug: esomeprazole
esomeprazole dosed qam for 8 weeks
Other Name: Nexium


Outcome Measures
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Primary Outcome Measures :
  1. To measure change in eosinophil infiltration and degranulation at 8 weeks in response to treatment of allergy versus treatment for GER in EE patients [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. To assess change in dysphagia score, GERD symptoms, allergy/atopy at 8 weeks using validated questionnaires [ Time Frame: 8 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 18-80 with EE, defined as: a) dysphagia, food impaction or other upper gastrointestinal symptoms (chest pain, heartburn, regurgitation); b) multiple esophageal rings or furrows; c) the presence of >20 eosinophils/high power field in the squamous epithelium or deeper tissues of the esophagus
  • Ability to undergo esophageal manometry and ambulatory pH monitoring
  • No history of bleeding diathesis, significant cardiopulmonary disease, or other contraindication to upper endoscopy
  • Those who have had a one month holiday from either esomeprazole therapy or fluticasone if they have been prescribed this prior to enrollment

Exclusion Criteria:

  • Contraindication to proton pump inhibitors or swallowed fluticasone
  • Need for immediate esophageal dilation at enrollment due to food impaction at the discretion of the performing endoscopist
  • Inability to pass endoscope
  • Pregnancy
  • Incarceration
  • Inability to provide informed consent
  • History of esophago-gastric surgery or prior history of abdominal surgery with subsequent strictures or symptoms of obstruction such as abdominal pain and bloating
  • Presence of other esophageal pathology that could account for patients' symptoms as determined by histological interpretation by the pathologist
  • History of esophageal spasm resulting in trouble swallowing foods larger than 1 cm in diameter
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00123656


Locations
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United States, Utah
University of Utah HSC
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
American Society for Gastrointestinal Endoscopy
Investigators
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Principal Investigator: John C. Fang, M.D. University of Utah HSC
More Information
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Responsible Party: John C. Fang, M.D., University of Utah HSC
ClinicalTrials.gov Identifier: NCT00123656    
Other Study ID Numbers: 12790
First Posted: July 25, 2005    Key Record Dates
Last Update Posted: January 16, 2008
Last Verified: January 2008
Keywords provided by University of Utah:
Eosinophilic esophagitis
esomeprazole
fluticasone
Additional relevant MeSH terms:
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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