Safety and Efficacy Study of Omalizumab Given Prior to Immunotherapy

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

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).

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.

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