Allergic Asthma Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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