The Study About the Identification of Treatable Traits of Severe Asthma and the Construction of Personalized Treatment System
- Conditions
- Asthma
- Registration Number
- NCT07136025
- Lead Sponsor
- Beijing Chao Yang Hospital
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- 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 4. Allergy to macrolides
- QTc interval prolongation >480ms
- Taking medications that interact with azithromycin, causing QTc prolongation or existing ECG abnormalities, may lead to arrhythmia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Changes from baseline in asthma quality of life score (AQLQ) at 6 months 6 months
- Secondary Outcome Measures
Name Time Method The change of asthma Control questionnaire (ACQ-5) score At 6 months Forced Expiratory Volume in 1 second（FEV1） At 6 months Changes in lung function Forced Expiratory Volume in 1 second（FEV1） from baseline
the number of asthma exacerbations within 6 months within 6 months
Trial Locations
- Locations (9)
Beijing Institute of Respiratory Medicine and Beijing Chao-Yang Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Tiantan Hospital Affiliated to Capital Medical University
🇨🇳Beijing, Beijing, China
China-Japan Friendship Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Guangzhou Medical University
🇨🇳Shanghai, Shanghai, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
The First Affiliated Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Shanxi Bethune Hospital
🇨🇳Taiyuan, Shanxi, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Beijing Institute of Respiratory Medicine and Beijing Chao-Yang Hospital, Capital Medical University🇨🇳Beijing, Beijing, ChinaKewu HuangContact8613601234681kewuhuang@126.com