Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Shanghai Zhangjiang Biotechnology Limited Company
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.
Age
15–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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)
