Efficacy and Safety Evaluation of Omalizumab Combined With Standardized Allergen Specific Immunotherapy in Moderate to Severe Allergic Asthma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- the incidence rate of adverse reactions in standardized allergen immunotherapy
研究概览
简要总结
The combined treatment of anti-IgE monoclonal antibody and standardized allergen immunotherapy has good efficacy and safety in allergic diseases. However, the efficacy and safety of the combined treatment for allergic asthma in the Chinese population have not been fully elucidated yet.This study is a prospective observational study designed to evaluate the efficacy and safety of omalizumab combined with allergen immunotherapy (AIT) in patients with moderate to severe asthma in the Chinese population.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals who meet all of the following criteria are eligible for enrollment as study participants:
- •Chinese patients,aged 6 years and older，female or male
- •Diagnosed as allergic asthma according to the guideline for Chinese guidelines for the diagnosis and treatment of allergic asthma（2019，the first edition）
- •Meet the diagnostic criteria for moderate and severe asthma, in line with the diagnostic standards of the GINA (Global Initiative for Asthma)，it refers to those who can achieve complete control under the GINA Step 3 treatment; for severe asthma, it refers to those who need Step 4 or Step 5 treatment to achieve complete control, or those who still cannot achieve control even after undergoing Step 4 or Step 5 treatment.
- •The patients included in the study were positive for specific immunoglobulin E (sIgE), or had a positive skin prick test (SPT) with D.pteronyssinus and D. farinae allergens.
- •Patients who will initiate AIT or omalizumab combined with AIT according to real life clinical standards of practice.
排除标准
- •Individuals who meet any of the following criteria are not eligible for enrollment as study participants:
- •Uncontrolled asthma or forced expiratory volume in one second (FEV1) is lower than 70% of the predicted value.
- •Currently receiving treatment of beta blockers or angiotensin converting enzyme inhibitor (ACEI) 3．With severe or uncontrolled cardio-cerebral vascular, hepatic, renal, gastrointestinal, hematopoietic，genitourinary, endocrine, nervous and immunological medical conditions, or other conditions that investigators think the patient not suitable for this study.
- •4．Pregnant or planning pregnancy.
研究组 & 干预措施
Allergen-specific immunotherapy alone group (AIT alone group)
Patients start to receive allergen-specific immunotherapy 1 to 3 months after asthma is under control.
干预措施: Allergen-specific immunotherapy(AIT) (Biological)
the omalizumab combined with allergen-specific immunotherapy group
Omalizumab treatment was administered 4 to 8 weeks before the initiation of standardized allergen-specific immunotherapy. After the initiation of standardized allergen-specific immunotherapy, the overlapping treatment with allergen-specific immunotherapy (AIT) and omalizumab was continued.
干预措施: Allergen-specific immunotherapy(AIT) (Biological)
the omalizumab combined with allergen-specific immunotherapy group
Omalizumab treatment was administered 4 to 8 weeks before the initiation of standardized allergen-specific immunotherapy. After the initiation of standardized allergen-specific immunotherapy, the overlapping treatment with allergen-specific immunotherapy (AIT) and omalizumab was continued.
干预措施: omalizumab (Biological)
结局指标
主要结局
the incidence rate of adverse reactions in standardized allergen immunotherapy
时间窗: The observation time of this study is one year, starting from the time when the patient begins AIT therapy and followed up for one year.
Adverse reactions of allergen immunotherapy (AIT) can be divided into local adverse reactions and systemic adverse reactions according to the occurrence sites. Local adverse reactions mainly include itching, redness, swelling, induration and even necrosis at the allergen injection sites. Systemic adverse reactions of AIT include cough, dyspnea, urticaria, asthma attacks and so on, and can lead to anaphylactic shock in severe cases.In this study, the incidence rates of adverse reactions in the two groups of patients were taken as the main research indicators to evaluate the role of omalizumab in the process of desensitization treatment.
次要结局
未报告次要终点
研究者
Lili Zhi
Dr. Prof.
Qianfoshan Hospital