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
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
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
Parallel
Individualized cluster management
Procedure/SurgeryIndividualized cluster management for treatable traits
Routine asthma treatment
Procedure/SurgeryRoutine asthma treatment according to current guidelines
Changes from baseline in asthma quality of life score (AQLQ) at 6 months
The change of asthma Control questionnaire (ACQ-5) score
Forced Expiratory Volume in 1 second（FEV1）
Changes in lung function Forced Expiratory Volume in 1 second（FEV1） from baseline
the number of asthma exacerbations within 6 months
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Beijing Chao Yang Hospital
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborator
The First Affiliated Hospital of Guangzhou Medical University
Collaborator
Shanxi Bethune Hospital
Collaborator
Henan Provincial People's Hospital
Collaborator
First Hospital of China Medical University
Collaborator
China-Japan Friendship Hospital
Collaborator
Beijing Tiantan Hospital
Collaborator
Second Xiangya Hospital of Central South University
Collaborator
Ruijin Hospital
Collaborator
