Safety and Efficacy Study of Omalizumab to Treat Allergic Asthma
- Registration Number
- NCT01976208
- Lead Sponsor
- Shanghai Zhangjiang Biotechnology Limited Company
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 630
- 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.
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo 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. Omalizumab 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.
- Primary Outcome Measures
Name Time Method The proportion of patients with asthma exacerbation 32 weeks
- Secondary Outcome Measures
Name Time Method 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
Related Research Topics
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Trial Locations
- Locations (27)
Peking Union Medical College Hospital
🇨🇳Beijing, China
Chinese PLA Fuzhou General Hospital of Nanjing Military Command
🇨🇳Fuzhou, China
The Second Affiliated Hospital of Zhejiang University
🇨🇳Hangzhou, China
Beijing Chaoyang Hospital
🇨🇳Beijing, China
Shanghai Changzheng Hospital
🇨🇳Shanghai, China
The Second Hospital of Hebei Medical University
🇨🇳Shijiazhuang, China
Peking University People's Hospital
🇨🇳Beijing, China
South Hospital of South Medical University
🇨🇳Guangzhou, China
Sir Run Run Shaw Hospital of Zhejiang University
🇨🇳Hangzhou, China
Zhongshan Hospital, Fudan University
🇨🇳Shanghai, China
Shanghai First People's Hospital
🇨🇳Shanghai, China
The Second Hospital of Jilin University
🇨🇳Changchun, China
West China Hospital, Sichuan University
🇨🇳Chengdu, China
The First hospital of China Medical University
🇨🇳Shenyang, China
The First Affiliated Hospital of Guangxi Medical University
🇨🇳Nanning, China
Qingdao Municipal Hospital
🇨🇳Qingdao, China
Chinese PLA Shenyang Military Command General Hospital
🇨🇳Shenyang, 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
Chongqing Xinqiao Hospital
🇨🇳Chongqing, China
The First Affiliated Hospital of Zhejiang University
🇨🇳Hangzhou, China
Chinese PLA Jinan Military General Hospital
🇨🇳Jinan, China
Shandong Provincial Hospital
🇨🇳Jinan, China
China-Japan Friendship Hospital
🇨🇳Beijing, Beijing, China
Jiangsu Province Hospital
🇨🇳Nanjing, China
Zhongda Hospital, Southeast University
🇨🇳Nanjing, China