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

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Beijing Institute of Respiratory Medicine and Beijing Chao-Yang Hospital, Capital Medical University
RECRUITING
Beijing
Beijing Tiantan Hospital Affiliated to Capital Medical University
RECRUITING
Beijing
China-Japan Friendship Hospital
RECRUITING
Beijing
The Second Xiangya Hospital of Central South University
RECRUITING
Changsha
The First Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
The Second Affiliated Hospital of Zhejiang University School of Medicine
RECRUITING
Hangzhou
The First Affiliated Hospital of Guangzhou Medical University
RECRUITING
Shanghai
The First Affiliated Hospital of China Medical University
RECRUITING
Shenyang
Shanxi Bethune Hospital
RECRUITING
Taiyuan
Henan Provincial People's Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Kewu Huang, professor
kewuhuang@126.com
8613601234681
Time Frame
Start Date: 2025-02-01
Estimated Completion Date: 2029-01-31
Participants
Target number of participants: 200
Treatments
Experimental: Intervention group
Implement individualized cluster management based on treatable traits
Other: Placebo
Routine asthma treatment according to current guidelines
Related Therapeutic Areas
Sponsors
Collaborators: Second Affiliated Hospital, School of Medicine, Zhejiang University, China-Japan Friendship Hospital, Henan Provincial People's Hospital, The First Affiliated Hospital of Guangzhou Medical University, Ruijin Hospital, Shanxi Bethune Hospital, First Affiliated Hospital of China Medical University, Second Xiangya Hospital of Central South University, Beijing Tiantan Hospital
Leads: Beijing Chao Yang Hospital

This content was sourced from clinicaltrials.gov