Individualized cluster management
ProcedureIndividualized cluster management for treatable traits
NCT Number: NCT06811740
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Beijing Institute of Respiratory Medicine and Beijing Chao-Yang Hospital, Capital Medical University, Beijing, Beijing Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Individualized cluster management for treatable traits
Routine asthma treatment according to current guidelines
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Changes in lung function Forced Expiratory Volume in 1 second(FEV1) from baseline
Time frame: 6 months
the number of acute asthma attacks within 6 months
Beijing Chao Yang Hospital
Other
The Study About the Identification of Treatable Traits of Severe Asthma and the Construction of Personalized Treatment System
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