The Effect of Xolair (Omalizumab) on Allergy Blood Cells

Study Overview
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Brief Summary
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We are studying Xolair (omalizumab) to see it's effect on allergic blood cells. The blood tests will be done in a test tube to see if they react differently before and after treatment. The blood cells will be mixed with to whatever the person is allergic.

Detailed Description
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Must be allergic-asthma with IgE between 30 and 700 IU/ml.

Official Title
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The Effect of Xolair (Omalizumab) on Inhibiting Leukotriene and Cytokine (IL-4 and IL-13) Release From Blood Basophils

Conditions
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Asthma

Intervention / Treatment
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* Drug: Omalizumab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 2 year history of ragweed allergic rhinitis positive skin prick tests to ragweed >5 mm wheal diameter serum IgE <700 iU/m Exclusion Criteria: Use of prohibited medications (e.g. antihistamine in past 7 days and topical or oral corticosteroids in past 1 month, beta-agonist or theophylline for 1 week History of immunotherapy in the past 2 years Exposure to Omalizumab in the past 2 years Clinically significant non-allergic or perennial rhinitis to avoid mediator release due to environmental allergens Asthma other than mild intermittent Women of childbearing potential who are not on an accepted form of birth control, as well as women who are breastfeeding Known sensitivity to study drug Xolair Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study Patients with a previous history of cancer Use of any other investigational agent in the last 30 days

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo Injection | Drug: Placebo<br>* Placebo Injection<br>|
| Experimental: 2<br>Xolair at 0.016 mg/kg/IgE(iu/ml)/4 wks | Drug: Omalizumab<br>* 0.016 mg/kg/IgE(iU/ml)/4 wks, Subcutaneously<br>* Other names: rhumabe35;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if Xolair (omalizumab) inhibits basophil leukotriene secretion & to compare this with its inhibition of histamine release. We will also compare this inhibition in basophils stimulated with allergen vs anti-IgE vs calcium ionophore. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effect of Xolair (omalizumab) on IL-4 &vIL-13 secretion. To compare the effect of Xolair on IL-4 vs IL-13 secretion from basophils stimulated with allergen, anti-IgE & calcium ionophore (ionomycin). |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergic Asthma, Anti IgE, Xolair, Basophil, IL-13, IL-4, Histamine