The Study About the Identification of Treatable Traits of Severe Asthma and the Construction of Personalized Treatment System

ConditionAsthma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBeijing Chao Yang Hospital

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Individualized cluster management
  • Routine asthma treatment

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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