Esophagitis Clinical Trial
Official title:
A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab
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
This is a dual-center double-blind, placebo controlled trial of omalizumab for the treatment of EE. Omalizumab will be dosed depending on the patient's 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. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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