Esophagitis Clinical Trial
Official title:
A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab
Verified date | March 2016 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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
Status | Completed |
Enrollment | 30 |
Est. completion date | January 2010 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Male or female subjects aged 12-60 years of age with EE as defined above - Serum IgE level 30-700 IU/mL - Subjects with acceptable medical history, physical exam and laboratory test results - No history of bleeding diathesis, significant cardiopulmonary disease, or other contraindication to upper endoscopy Exclusion Criteria: - Need for esophageal dilation at enrollment due to food impaction or inability to pass endoscope - Inability of subject to provide informed consent (if ages 18-60), or inability of children (ages 12-17) to provide assent - History of esophagogastric surgery - Presence of other esophageal pathology that could account for patients' symptoms including eosinophil infiltration due to gastroesophageal reflux disease (GERD) - Incarceration - Pregnancy - Women of childbearing potential not using the contraception method(s) - Patients with elevated serum IgE levels for reasons other than atopy - Patients taking cromolyn sodium or nedocromil sodium within 1 month of visit 1 - Patients taking oral or topical corticosteroids within one month of visit 1 - Patients taking leukotriene receptor inhibitors within one month of visit 1 - Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study - Patients with a history of noncompliance to medical regimens or who were considered potentially unreliable - Use of any other investigational agent in the last 30 days - Patients with a known hypersensitivity to any ingredient of rhuMAb-E25, study rescue medication - Patients with Barrett's esophagus will be excluded if found endoscopically or pathologically at biopsy - Currently treated with omalizumab or treated with omalizumab within the past 6 months. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Utah HSC | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah | Novartis Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Eosinophil Numbers Per High Power Field Proximally and Distally Between Baseline and Post-treatment and Between Both Groups | 16 weeks | No |
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