Safety and Efficacy Study of Omalizumab to Treat Allergic Asthma
AA007
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
1 other identifier
interventional
630
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2010
Longer than P75 for phase_2
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 23, 2013
CompletedFirst Posted
Study publicly available on registry
November 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedDecember 22, 2015
December 1, 2015
5 years
October 23, 2013
December 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The proportion of patients with asthma exacerbation
32 weeks
Secondary Outcomes (2)
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
Study Arms (2)
Omalizumab
EXPERIMENTALDuring 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 COMPARATORDuring 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Nanshan Zhong, M.D.
The First Affiliated Hospital of Guangzhou Medical University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2013
First Posted
November 5, 2013
Study Start
December 1, 2010
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
December 22, 2015
Record last verified: 2015-12