Asthma
Conditions
Keywords
treatable traits, asthma, sever, AQLQ, ACQ
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
Interventions
PROCEDUREIndividualized cluster management
Individualized cluster management for treatable traits
PROCEDURERoutine asthma treatment
Routine asthma treatment according to current guidelines
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
The First Affiliated Hospital of Guangzhou Medical University
Shanxi Bethune Hospital
Henan Provincial People's Hospital
First Affiliated Hospital of China Medical University
China-Japan Friendship Hospital
Beijing Tiantan Hospital
Second Xiangya Hospital of Central South University
Ruijin Hospital
Beijing Chao Yang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline in asthma quality of life score (AQLQ) at 6 months | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
China
Contacts
Primary ContactKewu Huang, professor
Outcome results
None listed