Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00123656 |
Recruitment Status :
Completed
First Posted : July 25, 2005
Last Update Posted : January 16, 2008
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Esophagitis | Drug: esomeprazole Drug: fluticasone | Phase 2 |
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 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 |

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 |
- 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 ]
- To assess change in dysphagia score, GERD symptoms, allergy/atopy at 8 weeks using validated questionnaires [ Time Frame: 8 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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: | 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 |
Eosinophilic esophagitis esomeprazole fluticasone |
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 |