Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00123656
Status:
COMPLETED
Last Update Posted:
2008-01-16
First Post:
2005-07-21
Brief Title:
Comparison of Esomeprazole to Aerosolized Swallowed Fluticasone for Eosinophilic Esophagitis
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
Comparison of Esomeprazole to Aerosolized Swallowed Fluticasone for Eosinophilic Esophagitis
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 allergyatopy 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 allergyatopy questionnaires will be repeated as will serum eosinophil counts and IgE measurements
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 allergyatopy 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 allergyatopy questionnaires will be repeated as will serum eosinophil counts and IgE measurements
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None