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Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis

Primary Purpose

Esophagitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
esomeprazole
fluticasone
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophagitis focused on measuring Eosinophilic esophagitis, esomeprazole, fluticasone

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Utah HSC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

fluticasone

esomeprazole

Outcomes

Primary Outcome Measures

To measure change in eosinophil infiltration and degranulation at 8 weeks in response to treatment of allergy versus treatment for GER in EE patients

Secondary Outcome Measures

To assess change in dysphagia score, GERD symptoms, allergy/atopy at 8 weeks using validated questionnaires

Full Information

First Posted
July 21, 2005
Last Updated
January 10, 2008
Sponsor
University of Utah
Collaborators
American Society for Gastrointestinal Endoscopy
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1. Study Identification

Unique Protocol Identification Number
NCT00123656
Brief Title
Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis
Official Title
Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Utah
Collaborators
American Society for Gastrointestinal Endoscopy

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophagitis
Keywords
Eosinophilic esophagitis, esomeprazole, fluticasone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
fluticasone
Arm Title
2
Arm Type
Active Comparator
Arm Description
esomeprazole
Intervention Type
Drug
Intervention Name(s)
esomeprazole
Other Intervention Name(s)
Nexium
Intervention Description
esomeprazole dosed qam for 8 weeks
Intervention Type
Drug
Intervention Name(s)
fluticasone
Other Intervention Name(s)
Flovent
Intervention Description
fluticasone dosed 220 mcg 2 puffs swallowed BID for 8 weeks
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To assess change in dysphagia score, GERD symptoms, allergy/atopy at 8 weeks using validated questionnaires
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John C. Fang, M.D.
Organizational Affiliation
University of Utah HSC
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah HSC
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

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Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis

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