Safety and Efficacy Study of Omalizumab to Treat Allergic Asthma

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Zhangjiang Biotechnology Limited Company
• Treatments: Antibodies; Antibodies, Monoclonal; Omalizumab

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