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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omalizumab | Experimental | 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. |
|
| placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omalizumab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with asthma exacerbation | 32 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Patients who met the below criteria were excluded:
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| Name | Affiliation | Role |
|---|---|---|
| Nanshan Zhong, M.D. | The First Affiliated Hospital of Guangzhou Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Beijing | Beijing Municipality | China | |||
| Beijing Chaoyang Hospital |
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|
|
| placebo | Drug |
|
| Beijing |
| China |
| Peking Union Medical College Hospital | Beijing | China |
| Peking University People's Hospital | Beijing | China |
| The Second Hospital of Jilin University | Changchun | China |
| West China Hospital, Sichuan University | Chengdu | China |
| Chongqing Xinqiao Hospital | Chongqing | China |
| Chinese PLA Fuzhou General Hospital of Nanjing Military Command | Fuzhou | China |
| South Hospital of South Medical University | Guangzhou | China |
| Sir Run Run Shaw Hospital of Zhejiang University | Hangzhou | China |
| The First Affiliated Hospital of Zhejiang University | Hangzhou | China |
| The Second Affiliated Hospital of Zhejiang University | Hangzhou | China |
| Chinese PLA Jinan Military General Hospital | Jinan | China |
| Shandong Provincial Hospital | Jinan | China |
| Jiangsu Province Hospital | Nanjing | China |
| Zhongda Hospital, Southeast University | Nanjing | China |
| The First Affiliated Hospital of Guangxi Medical University | Nanning | China |
| Qingdao Municipal Hospital | Qingdao | China |
| Shanghai Changzheng Hospital | Shanghai | China |
| Shanghai First People's Hospital | Shanghai | China |
| Zhongshan Hospital, Fudan University | Shanghai | China |
| Chinese PLA Shenyang Military Command General Hospital | Shenyang | China |
| The First hospital of China Medical University | Shenyang | China |
| The Second Hospital of Hebei Medical University | Shijiazhuang | China |
| The Second Hospital of Tianjin Medica University | Tianjin | China |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and technology | Wuhan | China |
| Xi'an Xijing Hospital | Xi'an | China |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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