The Efficacy and Safety of Omalizumab in the Treatment of Moderate to Severe Allergic Asthma:A Retrospective Single-center Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Global Evaluation of Treatment Effectiveness (GETE)
研究概览
简要总结
Allergic asthma being the most widespread and easily identifiable phenotype, accounting for 60-80% of cases.Previous studies have reported that nearly 90% of patients with severe asthma were cases of allergic asthma, in which Immunoglobulin E (IgE) plays a critical role.Omalizumab was approved as an anti-IgE humanized monoclonal antibody for the treatment of patients with poorly controlled moderate-to-severe asthma, and was the first targeted drug used in the field of asthma treatment.The drug was launched in mainland China in August 2017.whereas,the clinical application experience, effects, and relevant data in the domestic population still lacking.The aim of this study was to observe the efficacy and safety of omalizumab, and to investigate whether baseline clinical characteristics and biomarkers can predicted response and adherence to treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 14 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate-to-severe asthma patients aged ≥ 14 years who met the criteria of the Asthma Group of the Chinese Thoracic Society (Guidelines for bronchial asthma prevention and management, 2020 edition)-moderate asthma was defined as those who could achieve complete control using grade 3 therapy, and severe asthma was defined as fully or incompletely controlled with grade 4 or 5 asthma medications.
- •History of asthma exacerbations induced by allergen exposure , elevated total serum IgE and positive specific IgE test or positive skin prick test.
- •Treatment with omalizumab.
排除标准
- •Hypersensitivity to the active ingredient of omalizumab.
- •Asthma exacerbation in the baseline.
- •Combined with diseases that severely affect ventilation,such as bronchiectasis, lung cancer, allergic bronchopulmonary aspergillosis (ABPA), acute respiratory infections, chronic obstructive pulmonary disease (COPD),etc.
- •Receiving other biologically targeted therapies (e.g., anti-interleukin (IL)-5 monoclonal antibody, anti-IL-4 monoclonal antibody, anti-IL-13 monoclonal antibody, anti-IL-5 receptor α (IL-5Rα) monoclonal antibody, etc.)
研究组 & 干预措施
Responder group
The improvement in ACT score ≥ 3,or pre-treatment ACT score < 20 and a post-treatment ACT score ≥ 20；The GETE score was excellent or good.
干预措施: IgE monoclonal antibody (Drug)
No-Responder group
The improvement in ACT score < 3;The GETE score was moderate,poor and worse.
干预措施: IgE monoclonal antibody (Drug)
Good adherence
The proportion of patients whose missed doses of omalizumab fewer than 10% of all doses over the1 year, we think these patients were good adherence.
干预措施: IgE monoclonal antibody (Drug)
Poor adherence
the proportion of patients who missed at least 10% of all doses over the 1year,we think these patients were poor adherence.
干预措施: IgE monoclonal antibody (Drug)
结局指标
主要结局
Global Evaluation of Treatment Effectiveness (GETE)
时间窗: Baseline, up to16weeks，24weeks and 1year of treatment.
Global Evaluation of Treatment Effectiveness (GETE) score after omalizumab treatment. The responder in GETE is score of "excellent" or"good" after treatment.
Change in Asthma Control Test (ACT)
时间窗: Baseline, up to16weeks，24weeks and 1year of treatment.
The responder in ACT was required to meet any of the following conditions:(a) an improvement in ACT score ≥ 3 (MID); and (b) a pre-treatment ACT score \< 20 (poor or poorly controlled asthma) and a post-treatment ACT score ≥ 20 (well controlled asthma).
次要结局
- Forced Expiratory Volume in 1 second（FEV1)(Baseline, up to 16weeks，24weeks and 1year of treatment.)
- Oral glucocorticoid dosage(up to16weeks，24weeks and 1year of treatment.)
- Good adherence(1 year)
- Forced Vital Capacity （FVC）(Baseline, up to16weeks，24weeks and 1year of treatment.)
- Number of Acute Exacerbations（AE）(up to16weeks，24weeks and 1year of treatment.)
- Adverse events(up to16weeks，24weeks and 1year of treatment.)
- FEV1/predicted%.(Baseline, up to 16weeks，24weeks and 1year of treatment.)
- Poor adherence(1 year)
- FEV1/FVC.(Baseline, up to16weeks，24weeks and 1year of treatment.)