Safety and Efficacy Study of Omalizumab to Treat Allergic Asthma

A Multicenter, Randomized, Double-blinded, Placebo-controlled Clinical Study to Evaluate the Safety and Efficacy of Recombinant Humanized Anti-IgE Monoclonal Antibody Injection(Omalizumab) in Patients With Allergic Asthma

The primary purpose is to evaluate the safety and efficacy of recombinant humanized anti-IgE monoclonal antibody injection in patients with allergic asthma.

Omalizumab will be given as add-on treatment to budesonide inhaled powder in patients with moderate or severe allergic asthma(IgE>=60IU/ml), who demonstrate inadequate asthma symptom control. Response to Omalizumab will be assessed by the overall improvement in control of asthma.

Omalizumab is a recombinant humanized monoclonal antibody that selectively binds to human immunoglobulin E(IgE). The antibody has a molecular weight of approximately 150 kilodaltons and produced by Chinese Hamster Ovary cell.

Omalizumab inhibits the binding of IgE to the high-affinity IgE receptor on the surface of mast cells and basophils. Reduction in surface-bound IgE on cells limits the degree of release of mediators of the allergic response.

Inclusion Criteria:

• Male or female aged 15~65 years
• Written informed consent provided
• Total serum IgE >=60IU/ml
• Duration of allergic asthma >= 1 year according to GINA(2008)
• Poor response to moderate to high dose inhaled corticosteroid (400ug/day~800ug/day) >= 4 weeks
• Agreed to be not pregnant, contraception during study and later 6 months.

Exclusion Criteria:

Patients who met the below criteria were excluded:

• Be regular smokers(>10 cigarettes per day and for at least 2 years)
• Patients who are currently pregnant or nursing or intend to become pregnant over the course of the study or later 6 months
• COPD, according to the guideline of Chinese society of respiratory diseases
• An active lung disease other than allergic asthma
• Patients with significant underlying medical conditions
• Allergic to immunoglobin or any formulation ingredient of the product
• Patients with diabetes or uncontrolled hypertension(Systolic blood pressure>160mmHg or Diastolic blood pressure>95mmHg)
• HIV positivity or cancer patient
• Prior exposure to Xolair