Safety and Efficacy Study of Omalizumab to Treat Allergic Asthma
NCT ID: NCT01976208
Last Updated: 2015-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
630 participants
INTERVENTIONAL
2010-12-31
2015-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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 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.
Omalizumab
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.
placebo
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.
placebo
Interventions
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Omalizumab
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.
placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
15 Years
65 Years
ALL
No
Sponsors
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Shanghai Zhangjiang Biotechnology Limited Company
INDUSTRY
Responsible Party
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Principal Investigators
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Nanshan Zhong, M.D.
Role: STUDY_CHAIR
The First Affiliated Hospital of Guangzhou Medical University
Locations
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China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Beijing Chaoyang Hospital
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
Countries
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Other Identifiers
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CMAB007
Identifier Type: -
Identifier Source: org_study_id