A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab

Conditions

• Esophagitis

Eligibility Criteria

Sex

ALL

Age

12 Years - 60 Years

Healthy Volunteers

Not accepted

Interventions

• omalizumab — DRUG
  omalizumab dosed IV based on IgE level and weight every 2 - 4 weeks
• Placebo — DRUG
  Placebo given IV once every 2-4 weeks based on weight

Study Details

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

Key Dates

Start date

Nov 30, 2005

Status verified

Mar 2016

Primary completion

Jan 31, 2010

Completion

Jan 31, 2010

Study Design

Enrollment

30 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: placebo
  placebo group
• Experimental: omalizumab
  Xolair group

Primary Outcome Measure

Change in Eosinophil Numbers Per High Power Field Proximally and Distally Between Baseline and Post-treatment and Between Both Groups [ Time Frame: 16 weeks ]

Locations (1)

Find similar trials in Salt Lake City, UT

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