Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis - Full Text View

Sponsor:	University of Utah
Collaborator:	American Society for Gastrointestinal Endoscopy
Information provided by:	University of Utah
ClinicalTrials.gov Identifier:	NCT00123656

Purpose

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

Resource links provided by NLM:

MedlinePlus related topics: Allergy Endoscopy

Drug Information available for: Omeprazole Fluticasone propionate Fluticasone Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by University of Utah:

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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess change in dysphagia score, GERD symptoms, allergy/atopy at 8 weeks using validated questionnaires [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

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

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00123656

Locations

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

Principal Investigator:

John C. Fang, M.D.

University of Utah HSC

More Information

No publications provided

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

Keywords provided by University of Utah:

Eosinophilic esophagitis
esomeprazole
fluticasone

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on February 08, 2010