Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis

NCT00123656 | Completed Phase 2

• 1 other identifier: 12790
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophagitis

Keywords

Eosinophilic esophagitis; esomeprazole; fluticasone

Outcome Measures

Primary Outcomes (1)

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

  8 weeks

Secondary Outcomes (1)

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

  8 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

fluticasone

Drug: fluticasone

2

ACTIVE COMPARATOR

esomeprazole

Drug: esomeprazole

Interventions

esomeprazole DRUG

esomeprazole dosed qam for 8 weeks

Also known as: Nexium

2

fluticasone DRUG

fluticasone dosed 220 mcg 2 puffs swallowed BID for 8 weeks

Also known as: Flovent

1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead
• American Society for Gastrointestinal Endoscopy: collaborator

Study Sites (1)

University of Utah HSC

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Esophagitis; Eosinophilic Esophagitis

Interventions

Esomeprazole; Fluticasone

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• John C. Fang, M.D.

  University of Utah HSC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 21, 2005
• First Posted: July 25, 2005
• Study Start: August 1, 2004
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: January 16, 2008

Record last verified: 2008-01

Locations

US (1)