The Study About the Identification of Treatable Traits of Severe Asthma and the Construction of Personalized Treatment System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 10
- 主要终点
- Changes from baseline in asthma quality of life score (AQLQ) at 6 months
研究概览
简要总结
Severe asthma is a complex and heterogeneous disease. Patients with severe asthma can present with different types of airway inflammation, and are often accompanied by a variety of comorbidities and risk factors. Identification of potentially modifiable factors affecting prognosis, that is, "treatable characteristics", and individualized bundle management based on these characteristics may help to improve the quality of life of patients with asthma and improve the level of asthma control. Through joint research, this project aims to evaluate the treatable characteristics of asthma in patients with severe asthma in tertiary hospitals across the country, including lung function, fractional exhaled nitric oxide, blood routine, allergen IgE, chest CT, and a detailed questionnaire. The distribution of treatable characteristics of patients with severe asthma and its impact on the quality of life or asthma control level of patients were investigated. For patients with severe asthma, multidisciplinary consultation and shared decision-making were used to establish an individualized bundle management model based on the treatable characteristics of severe asthma. A 6-month randomized parallel controlled clinical trial was conducted to determine whether this model was superior to conventional management in improving the quality of life or asthma control in patients with severe asthma. The implementation of this project will build a new model of individualized management of severe asthma based on treatable characteristics and improve the management level of severe asthma
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years, and <80 years with a definite diagnosis of asthma for at least 6 months
- •Patients met the 2024 GINA criteria for severe asthma, which was defined as "uncontrolled" asthma (frequent asthma symptoms, or frequent acute exacerbations) despite high-dose inhaled corticosteroids (ICS) plus long-acting β2-receptor antagonists (LABAs), or worsening of symptoms after slight tapering of high-dose therapy.
- •They were willing to accept multi-disciplinary and multi-dimensional evaluation and signed informed consent
- •Informed consent was obtained and patients were able to participate in the study and 6-month follow-up according to the protocol
排除标准
- •The presence of numerous other lung tissue destructive diseases, such as severe bronchiectasis or pulmonary tuberculosis.
- •Chest surgery or abdominal surgery in the past 3 months
- •Eye surgery had been performed within the past 3 months
- •Myocardial infarction within the previous 3 months
- •Anti-tuberculosis treatment is ongoing
- •Women who are pregnant and lactating
- •Macrolide use within 4 weeks before the screening period
- •Treatment with anti-ige, anti-IL-5, or anti-IL-5R within 4 weeks before the screening period
- •Inhaled ICS+LABA+ long-acting anticholinergic agent (LAMA) for 4 weeks prior to the screening period
- •Allergy to macrolides
- •QTc interval prolongation >480ms
- •Taking medications that interact with azithromycin, causing QTc prolongation or existing ECG abnormalities, may lead to arrhythmia
结局指标
主要结局
Changes from baseline in asthma quality of life score (AQLQ) at 6 months
时间窗: 6 months
次要结局
- The change of asthma Control questionnaire (ACQ-5) score(At 6 months)
- Forced Expiratory Volume in 1 second（FEV1）(At 6 months)
- the number of asthma exacerbations within 6 months(within 6 months)