![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
Sponsors and Collaborators: |
University of Utah American Society for Gastrointestinal Endoscopy |
---|---|
Information provided by: | University of Utah |
ClinicalTrials.gov Identifier: | NCT00123656 |
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 | Intervention | Phase |
---|---|---|
Esophagitis |
Drug: esomeprazole Drug: fluticasone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis |
Enrollment: | 30 |
Study Start Date: | August 2004 |
Study Completion Date: | December 2006 |
Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
fluticasone
|
Drug: fluticasone
fluticasone dosed 220 mcg 2 puffs swallowed BID for 8 weeks
|
2: Active Comparator
esomeprazole
|
Drug: esomeprazole
esomeprazole dosed qam for 8 weeks
|
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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Utah | |
University of Utah HSC | |
Salt Lake City, Utah, United States, 84132 |
Principal Investigator: | John C. Fang, M.D. | University of Utah HSC |
Responsible Party: | University of Utah HSC ( John C. Fang, M.D. ) |
Study ID Numbers: | 12790 |
Study First Received: | July 21, 2005 |
Last Updated: | January 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00123656 History of Changes |
Health Authority: | United States: Institutional Review Board |
Eosinophilic esophagitis esomeprazole fluticasone |
Anti-Inflammatory Agents Gastrointestinal Diseases Omeprazole Anti-Asthmatic Agents Anti-Allergic Agents Eosinophilic Enteropathy Esophagitis |
Digestive System Diseases Esophageal Disorder Fluticasone Esophageal Diseases Peripheral Nervous System Agents Gastroenteritis Bronchodilator Agents |
Anti-Inflammatory Agents Respiratory System Agents Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Physiological Effects of Drugs Gastrointestinal Agents Anti-Asthmatic Agents Omeprazole Enzyme Inhibitors Anti-Allergic Agents Pharmacologic Actions |
Esophagitis Digestive System Diseases Autonomic Agents Therapeutic Uses Anti-Ulcer Agents Fluticasone Peripheral Nervous System Agents Esophageal Diseases Gastroenteritis Dermatologic Agents Bronchodilator Agents |