Allergic Asthma
Conditions
Keywords
Omalizumab, IgE, Asthma
Brief summary
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
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.
Interventions
DRUGOmalizumab
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.
DRUGplacebo
Sponsors
Shanghai Zhangjiang Biotechnology Limited Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
15 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with asthma exacerbation | 32 weeks |
Secondary
| Measure | 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 |
Countries
China
Outcome results
None listed