Safety and Efficacy Study of Omalizumab Given Prior to Immunotherapy

Study Overview
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Brief Summary
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In patients with at least moderate persistent allergic asthma controlled with inhaled steroids, omalizumab(administered per US product label), when compared to placebo, will provide the participants with significantly improved tolerability of specific allergen immunotherapy (allergy shots) administered per a cluster schedule(rapid build up method).

Detailed Description
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Omalizumab is an FDA approved anti-IgE drug used to treat allergic asthma. This study is designed to give omalizumab 13 weeks prior to administering rapid build up of specific allergy shot, with an overlap of omalizumab and cluster therapy for 3 weeks. The cluster therapy will take 4 week to complete with maintenance dosage lasting an additional 6 weeks.

Official Title
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A26-wk,Randomized,Dble-Blinded,Parallel-Grp,Placebo-Controlled,Multi-Centered Study to Eval.the Effect of Xolair(Omalizumab)on Improving the Tolerability of Spec.Immunotherapy in Patients With at Least Mod. Persistent Allergic Asthma Inadequately Controlled w/Inhaled Corticosteroids

Conditions
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Asthma

Intervention / Treatment
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* Drug: Xolair
* Drug: Xolair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical diagnosis and history of moderate persistent allergic asthma body weight >/= 20kg and </= 150kg Total serum IgE >/= 30 and </= 700IU/mL on a stable asthma treatment including corticosteroids for the preceding 4 weeks non smoker for at least 1 year prior to visit 1 Exclusion Criteria: patients with severe asthma history of immunotherapy to any allergen within the past 3 years history of anaphylactic allergic reaction upper respiratory tract infection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo will be compared to Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level. | Drug: Xolair<br>* Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.<br>* Other names: Omalizumab (Xolair);|
| Experimental: 2<br>Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level. | Drug: Xolair<br>* Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.<br>* Other names: Omalizumab (Xolair);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the effect of omalizumab on systemic allergic reactions to specific immunotherapy (SIT) in patients with persistent allergic asthma who require treatment with inhaled steroids |  | 2005-2007 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergic, Asthma, Immunotherapy