Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00123656
• Date of registration: 21/07/2005
• Prospective Registration: No
• Primary sponsor: University of Utah
• Public title: Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis
• Scientific title: Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis
• Date of first enrolment: August 2004
• Target sample size: 30
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00123656
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: John C. Fang, M.D.
• Affiliation: University of Utah HSC

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Esophagitis

Intervention(s)

Drug: fluticasone

Drug: esomeprazole

Primary Outcome(s)

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]

Secondary Outcome(s)

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

Secondary ID(s)

12790

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

American Society for Gastrointestinal Endoscopy