Clinical trial NCT01976208: Safety and Efficacy Study of Omalizumab to Treat Allergic Asthma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Allergic Asthma
Keywords: Omalizumab
IgE
Asthma
Lead sponsor: Shanghai Zhangjiang Biotechnology Limited Company
Sponsor class: INDUSTRY
First posted: 2013-11-05
Enrollment: 630
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The proportion of patients with asthma exacerbation
timeFrame: 32 weeks
Secondary outcomes:
measure: Pulmonary function measured by FEV1 and FEV1/FVC
timeFrame: 32 weeks
measure: Asthma symptoms evaluated by patients by using the Questionaire, Asthma Quality of Life Questionaire
timeFrame: 32 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Chaoyang Hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Peking University People's Hospital
city: Changchun
country: China
facility: The Second Hospital of Jilin University
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Chongqing
country: China
facility: Chongqing Xinqiao Hospital
city: Fuzhou
country: China
facility: Chinese PLA Fuzhou General Hospital of Nanjing Military Command
city: Guangzhou
country: China
facility: South Hospital of South Medical University
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital of Zhejiang University
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University
city: Jinan
country: China
facility: Chinese PLA Jinan Military General Hospital
city: Jinan
country: China
facility: Shandong Provincial Hospital
city: Nanjing
country: China
facility: Jiangsu Province Hospital
city: Nanjing
country: China
facility: Zhongda Hospital, Southeast University
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
city: Shanghai
country: China
facility: Shanghai First People's Hospital
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
city: Shenyang
country: China
facility: Chinese PLA Shenyang Military Command General Hospital
city: Shenyang
country: China
facility: The First hospital of China Medical University
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
city: Tianjin
country: China
facility: The Second Hospital of Tianjin Medica University
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and technology
city: Xi'an
country: China
facility: Xi'an Xijing Hospital
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Nanshan Zhong, M.D.
role: STUDY_CHAIR
References: