Asthma
Conditions
Keywords
treatable traits, asthma, severe, AQLQ, ACQ
Brief summary
Severe or uncontrolled asthma is a complex heterogeneous disease, in which patients may exhibit different types of airway inflammation and often accompany multiple comorbidities and risk factors. Identifying potential modifiable factors that influence prognosis, i.e., treatable traits, and targeting these traits for individualized, bundled management of patients may help improve the quality of life of asthma patients and enhance asthma control levels. This project aims to investigate the distribution of treatable traits in uncontrolled asthma patients in Beijing by conducting pulmonary function tests, exhaled nitric oxide tests, blood tests, allergen IgE tests, and chest CT scans, as well as detailed questionnaires, on patients from three tertiary hospitals in Beijing. The project will also assess the impact of treatable traits on the quality of life or asthma control levels of uncontrolled asthma patients in a multidimensional manner. Furthermore, the project will select severe asthma patients and establish an individualized, bundled management model based on the treatable traits of severe asthma, through multidisciplinary consultations and shared decision-making with patients. A randomized, parallel-group clinical trial will then be conducted for six months to confirm whether this management model is superior to conventional management in improving the quality of life or asthma control levels of severe asthma patients. The implementation of this project will establish a new model of individualized management for severe asthma based on treatable traits, thereby improving 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
Capital Medical University
Peking University Third 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 No maximum
Healthy volunteers
No
Inclusion criteria
* Must be at least 18 years old and have resided in Beijing for at least 6 months. * Must meet the diagnostic criteria for asthma as outlined in the 2023 GINA guidelines, have written evidence of variable airflow limitation, and have been receiving asthma treatment for at least 6 months. * Must meet one or both of the following criteria as defined in the 2023 GINA guidelines for uncontrolled asthma: poor symptom control (defined as an Asthma Control Questionnaire (ACQ-5) score of 0.75 or higher); frequent acute exacerbations (≥2 per year) requiring oral corticosteroids, or severe acute exacerbations (≥1 per year) requiring emergency or hospitalization. * Willing to undergo a multidisciplinary, multi-dimensional evaluation and sign an informed consent form. * Must meet the criteria for severe asthma as outlined in the 2023 GINA guidelines
Exclusion criteria
* Use macrolides within 4 weeks of the screening period * Use anti-IgE, anti-IL-5, or anti-IL-5R therapy within 4 weeks of the screening period * Use inhaled ICS + LABA + long-acting muscarinic antagonist (LAMA) within 4 weeks of the screening period * Be allergic to macrolides * Have a QTc interval prolongation of \>480ms * Take a medication that interacts with azithromycin to prolong the QTc interval or cause existing ECG abnormalities, which may lead to arrhythmias.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Quality of life score (AQLQ) | 6 months | Changes in asthma Quality of life score (AQLQ) from baseline at 6 months；Asthma Quality of Life questionnaire (AQLQ) is a scoring scale to evaluate the quality of life of patients with asthma, evaluating the level of asthma control in the past 2 weeks. The AQLQ consisted of 32 questions, which were divided into four sub-areas: symptoms (12 questions), activity limitation (11 questions), emotional function (5 questions) and environmental stimulation (4 questions). Each question was scored on a scale of 1 to 7 points according to its severity, with 1 indicating complete limitation and 7 indicating no limitation at all. The total score is calculated as the average of all questions and the average of each partition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Control Questionnaire score (ACQ-5) | 6 months | Changes in Asthma Control Questionnaire score (ACQ-5) from baseline at 6 months；ACQ-5 (Asthma Control Questionnaire) is a scoring scale for assessing asthma control. It consists of 5 simple questions to assess a patient's level of asthma control in the past week. Each problem was scored on a scale of 0-6 according to its severity. The average score of the five problems \<0.75 was asthma control, 0.75 \ 1.5 was asthma partial control, and \>1.5 was asthma uncontrolled. |
| Forced Expiratory Volume in 1 second（FEV1） | 6 months | Changes in lung function Forced Expiratory Volume in 1 second（FEV1） from baseline |
| Exacerbation | 6 months | the number of acute asthma attacks within 6 months |
Countries
China
Outcome results
None listed