A Phase 2/3 interventional study of Omalizumab and placebo in Allergic Asthma, sponsored by Shanghai Zhangjiang Biotechnology Limited Company. Completed at 27 sites in China. Open to participants aged 15 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-12-22.
Sponsored by Shanghai Zhangjiang Biotechnology Limited Company · Phase 2/3, Interventional, and Treatment
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 630 is above the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Shanghai Zhangjiang Biotechnology Limited Company is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients who met the below criteria were excluded:
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
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
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.
Also known as: other name: Aomaishu, Recombinant Humanized Anti-IgE Monoclonal Antibody
The proportion of patients with asthma exacerbation
Time frame: 32 weeks
Pulmonary function measured by FEV1 and FEV1/FVC
Time frame: 32 weeks
Asthma symptoms evaluated by patients by using the Questionaire, Asthma Quality of Life Questionaire
Time frame: 32 weeks
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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Shanghai Zhangjiang Biotechnology Limited Company