The primary objective of this study is to evaluate whether GDMT can bring significant benefits to disease management in uncontrolled asthma patients receiving medium- to high-dose ICS-LABA.
* The intervention period will be up to 48 weeks; * The frequency of follow-up is every 12 weeks.
Sign the informed consent form before any study-related procedures;
Age 18-75 years (inclusive) at Visit 0;
Have a written diagnosis of asthma for more than 6 months prior to Visit 0, and have evidence of reversible airflow limitation prior to Visit 0. Evidence of reversible airflow limitation includes: post-bronchodilator increase in Forced Expiratory Volume in 1 second (FEV1) of ≥12% and an absolute increase of ≥200 mL, or average daily diurnal Peak Expiratory Flow (PEF) variability >10%, or an increase in FEV1 of ≥12% and an absolute increase of ≥200 mL compared to baseline after 4 weeks of treatment containing ICS, or a positive bronchial provocation test record. If no prior record exists, reversible airflow limitation must be confirmed and documented via a bronchodilator test during Visit 0;
Under the usage of MD/HD ICS-LABA;
Previous written diagnosis as "Severe Asthma"; Diagnosis of Severe Asthma includes: severe asthma, or related diagnoses containing "severe asthma", or "bronchial asthma (severe)".
Imaging suggests the presence of bullae or cystic bronchiectasis;
Currently participating in other interventional studies;
Previous use of biologics for asthma treatment;
Parallel
Intervention group
BehavioralThe GDMT pathway targets physicians and specialized nurses for implementation. It ensures that physicians at intervention groups conduct standardized diagnosis and treatment following GDMT, and that specialized nurses deliver patient education and follow-up reminders according to GDMT. This is achieved through regular knowledge training, provision of a series of reminder/support tools, and a bi-weekly (every 12 weeks) monitoring, and feedback system for Key Performance Indicators (KPIs).
Difference in the proportion of participants with a written diagnosis of "Severe Asthma" between the intervention and control groups at Week 24
To evaluate the effect of GDMT education on diagnosis rates of severe asthma
Difference in the annualized asthma exacerbation rate between the intervention and control groups at Week 48
To evaluate the effect of GDMT education on asthma exacerbations
Difference in the proportion of participants with asthma exacerbation between the intervention and control groups at Week 48
To evaluate the effect of GDMT education on asthma control
Difference in the change in mean ACT score from baseline between the intervention and control groups at Week 48
To evaluate the effect of GDMT education on asthma control
Change in mean ACT score from baseline in the intervention group at Week 24 and 48
To evaluate the effect of GDMT education on asthma control
Change in the proportion of participants achieving asthma symptom control (ACT ≥20) from baseline in the intervention group at Week 24 and 48
To evaluate the effect of GDMT education on asthma control
Difference in the proportion of participants achieving clinical remission of asthma (CR3/CR4)f between the intervention and control groups at Week 48
To evaluate the effect of GDMT education on clinical remission of asthma
Characteristics of participants using biologics during the study period, including age, gender, disease duration, MH, insurance type, annual household income, asthma symptoms, comorbidities, EOS/FeNO/IgE levels, pulmonary function etc.
To describe the characteristics of participants using biologics
Proportion of participants receiving maintenance OCS therapyi at Week 24 and 48
To assess the effect of GDMT education on oral corticosteroid (OCS) use
Difference in the accumulative dose of maintenance OCS received between the intervention and control groups at Week 24 and 48
To assess the effect of GDMT education on oral corticosteroid (OCS) use
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