Safety and Efficacy Study of Omalizumab to Treat Allergic Asthma

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

Detailed Description
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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.

Official Title
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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

Conditions
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Allergic 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: 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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 65 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 |
| --- | --- |
| Experimental: Omalizumab<br>During the 4 6-week Run-in phase, the dosage of budesonide inhaled powder(BUD) was prescribed and optimized to maintain asthma control according to Global Initiative for Asthma(GINA, 2008) guidelines. During the following treatment phase, patients continued to receive optimized BUD and Omalizumab for 28 weeks, administered by subcutaneous injection every 2 weeks or 4 weeks. The dosage of Omalizumab received was based on body weight and serum IgE. | Drug: Omalizumab<br>* The recommended dose is 0.016mg/kg/IgE(IU/ml) every 4 weeks. It is administered by subcutaneous injection.If the total dose per 4 weeks is 150 300mg, the dosing interval will be every 4 weeks; if the total dose per 4 weeks is 450mg 750mg，then dosing interval is every 2 weeks.<br>* Other names: Recombinant Humanized Anti-IgE Monoclonal Antibody;|
| Placebo Comparator: placebo<br>During the 4 6-week Run-in phase, the dosage of budesonide inhaled powder(BUD) was prescribed and optimized to maintain asthma control according to Global Initiative for Asthma(GINA, 2008) guidelines. During the treatment phase, patients continued to receive placebo and optimized BUD for 28 weeks, administered by subcutaneous injection every 2 weeks or 4 weeks. | Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients with asthma exacerbation |  | 32 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary function measured by FEV1 and FEV1/FVC |  | 32 weeks | 
| Asthma symptoms evaluated by patients by using the Questionaire, Asthma Quality of Life Questionaire |  | 32 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Omalizumab, IgE, Asthma