Safety and Efficacy Study of Omalizumab to Treat Allergic Asthma

Allergic Asthma Clinical Trial

— AA007  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01976208
• Other study ID #: CMAB007
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 23, 2013
• Last updated: December 20, 2015
• Start date: December 2010
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Shanghai Zhangjiang Biotechnology Limited Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary purpose is to evaluate the safety and efficacy of recombinant humanized anti-IgE monoclonal antibody injection in patients with allergic asthma.

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 information / eligibility

• Status: Completed
• Enrollment: 630
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Asthma
• Asthma

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Beijing Chaoyang Hospital	Beijing
China	China-Japan Friendship Hospital	Beijing	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

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhangjiang Biotechnology Limited Company

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients with asthma exacerbation		32 weeks	No
Secondary	Pulmonary function measured by FEV1 and FEV1/FVC		32 weeks	No
Secondary	Asthma symptoms evaluated by patients by using the Questionaire, Asthma Quality of Life Questionaire		32 weeks	No