Status:
COMPLETED
Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis
Lead Sponsor:
University of Utah
Collaborating Sponsors:
American Society for Gastrointestinal Endoscopy
Conditions:
Esophagitis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 an...
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 init...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00123656
Start Date
August 1 2004
End Date
December 1 2006
Last Update
January 16 2008
Active Locations (1)
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1
University of Utah HSC
Salt Lake City, Utah, United States, 84132