A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab
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|ClinicalTrials.gov Identifier: NCT00123630|
Recruitment Status : Completed
First Posted : July 25, 2005
Results First Posted : October 21, 2013
Last Update Posted : May 20, 2016
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 allergy/atopy 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 elemental/elimination 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
|Condition or disease||Intervention/treatment||Phase|
|Esophagitis||Drug: omalizumab Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab|
|Study Start Date :||November 2005|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
Placebo Comparator: placebo
Placebo given IV once every 2-4 weeks based on weight
Other Name: saline
omalizumab dosed IV based on IgE level and weight every 2 - 4 weeks
Other Name: Xolair
- Change in Eosinophil Numbers Per High Power Field Proximally and Distally Between Baseline and Post-treatment and Between Both Groups [ Time Frame: 16 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00123630
|United States, Utah|
|University of Utah HSC|
|Salt Lake City, Utah, United States, 84132|
|Principal Investigator:||John C. Fang, M.D.||University of Utah HSC|