Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00123630
Status:
COMPLETED
Last Update Posted:
2016-05-20
First Post:
2005-07-21
Brief Title:
A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab
Status:
COMPLETED
Status Verified Date:
2016-03
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 an increasingly recognized condition characterized by dysphagia food impaction or other obstructive esophageal symptoms in children and young adults
The pathophysiology of EE appears to be an allergyatopy mediated disease A personal and family history of allergic diseases food allergies atopic dermatitis asthma allergic rhinitis or conjunctivitis has been noted in 62-85 of patients with EE The rising incidence of EE may be related to the worldwide allergy and asthma epidemic
Current treatment of EE is directed at decreasing esophageal allergic inflammation Oral and topical corticosteroids cromolyn sodium montelukast and elementalelimination diets have all been shown to be effective However none of these treatments are directed at the specific pathophysiologic mechanism of EE and some have significant side effects
The shared pathogenetic mechanisms of EE and asthma suggest that therapeutic strategies directed at asthma may also be effective for EE Specifically those targeted at the allergic immune mechanisms involved with asthma may be effective Omalizumab is a recently developed anti-IgE antibody that has been shown to decrease the use of inhaled and oral corticosteroids reduce the frequency of asthma exacerbations and improve asthma related symptoms in patients with allergic asthma The objective of the study is to determine the efficacy of omalizumab in the treatment of eosinophilic esophagitis
The pathophysiology of EE appears to be an allergyatopy mediated disease A personal and family history of allergic diseases food allergies atopic dermatitis asthma allergic rhinitis or conjunctivitis has been noted in 62-85 of patients with EE The rising incidence of EE may be related to the worldwide allergy and asthma epidemic
Current treatment of EE is directed at decreasing esophageal allergic inflammation Oral and topical corticosteroids cromolyn sodium montelukast and elementalelimination diets have all been shown to be effective However none of these treatments are directed at the specific pathophysiologic mechanism of EE and some have significant side effects
The shared pathogenetic mechanisms of EE and asthma suggest that therapeutic strategies directed at asthma may also be effective for EE Specifically those targeted at the allergic immune mechanisms involved with asthma may be effective Omalizumab is a recently developed anti-IgE antibody that has been shown to decrease the use of inhaled and oral corticosteroids reduce the frequency of asthma exacerbations and improve asthma related symptoms in patients with allergic asthma The objective of the study is to determine the efficacy of omalizumab in the treatment of eosinophilic esophagitis
Detailed Description:
This is a dual-center double-blind placebo controlled trial of omalizumab for the treatment of EE Omalizumab will be dosed depending on the patients body weight and baseline IgE level Omalizumab or placebo will be administered subcutaneously every 4 weeks for 16 weeks At study entry subjects will have EGD with biopsies performed to ensure the diagnosis and obtain tissue for histologic analysis No dilation will be performed at this time Baseline validated questionnaires for dysphagia GERD and atopy will also be administered Blood will be drawn for baseline serum testing Repeat questionnaires and rating of overall symptom improvement will be administered at 4 week intervals for the rest of the study period At the end of the 16 week period repeat endoscopy will be performed and biopsies taken Esophageal dilation may be performed if clinically indicated at this time Blood will also be drawn for repeat serum testing
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