Impact of GDMT in Uncontrolled Asthma Patients Receiving MHD Inhaled Corticosteroids + Long-acting β2 Agonist

This study is a prospective, multicenter, cluster-randomized trial conducted in China, designed to evaluate the application effect of Guideline-Directed Medical Therapy (GDMT). A scientific committee will be established to be responsible for developing GDMT educational materials and facilitating the implementation of GDMT. The study will introduce a GDMT pathway in intervention group aimed at guiding physicians and specialized nurses in the diagnosis and management of participants who are receiving medium- to high-dose ICS-LABA therapy but have uncontrolled asthma.

This study plans to include approximately 60 study sites and consecutively recruit approximately 540 participants. These sites will cover as many provinces and cities as possible to balance geographical distribution. For the 60 selected sites meeting the hospital qualification requirements, a stratified block randomization method will be used, with the stratification factor being the prior written diagnosis rate for severe asthma (the proportion of severe asthma written diagnoses among patients with asthma on medium-to-high dose ICS-LABA). Sites will be randomly allocated in a 1:1 ratio to either the intervention group or the control group (30 sites per group). To minimize selection bias, each site will consecutively enroll 9 participants who meet all inclusion criteria and have provided signed informed consent. All participants must complete the baseline study assessments before entering the study. This is a cluster-randomized interventional study, with an expected duration of 48 weeks. The intervention is implemented at the hospital level. Participants in the two groups will be managed as follows:

* Intervention Group: Physicians at the study sites will receive GDMT-related training and manage participants according to the GDMT diagnosis and treatment pathway. * Control Group: Physicians at the study sites will manage participants using usual clinical care.

Participant data (including but not limited to: demographic characteristics, number of exacerbations, asthma medication use, ACT scores, pulmonary function, SGRQ scores, medical costs) will be collected according to the Schedule of Study Activities.

The benefits and effectiveness of GDMT will be determined by assessing changes in physician behavior, improvements in patient outcomes, and savings in healthcare resources.

The intervention consists of 5 distinct components: routine training, GDMT education, clinical monitoring, targeted training, and material revision.

• Difference in the proportion of participants with asthma exacerbation between the intervention and control groups at Week 48 [Срок оценки: Week48]
• Difference in the change in mean ACT score from baseline between the intervention and control groups at Week 48 [Срок оценки: Baseline, week 48]
• Change in mean ACT score from baseline in the intervention group at Week 24 and 48 [Срок оценки: Baseline, week 24, week 48]
• Change in the proportion of participants achieving asthma symptom control (ACT ≥20) from baseline in the intervention group at Week 24 and 48 [Срок оценки: Baseline, week 24, week 48]
• Difference in the proportion of participants with asthma symptom control (ACT ≥20) between the intervention and control groups at Week 48 [Срок оценки: Week 48]
• Difference in the proportion of participants achieved the Minimal Clinically Important Difference (MCID) in asthma symptom control (ACT improvement ≥3 points) between the intervention and control groups at Week 48 [Срок оценки: Week 48]
• The proportion of participants achieved ACT MCID (ACT improvement ≥3 points) in the intervention group at Week 24 and 48 [Срок оценки: Week 24, week 48]
• Difference in pre-bronchodilator Forced Expiratory Volume in 1 second (Pre-BD FEV1) between the intervention and control groups at Week 48 [Срок оценки: Week 48]
• Change in pre-bronchodilator FEV1 (Pre-BD FEV1) from baseline in the intervention group at Week 24 and 48 [Срок оценки: Baseline, week 24, week 48]
• Difference in the proportion of participants with combined persistent airflow obstruction (PAO, FEV1/FVC <70%) between the intervention and control groups at Week 48 [Срок оценки: Week 48]
• Difference in St. George's Respiratory Questionnaire (SGRQ) scores (total and domain scores) between the intervention and control groups at Week 48 [Срок оценки: Week 48]
• Change in SGRQ scores from baseline in the intervention group at Week 24 and Week 48 [Срок оценки: Baseline, week 24, week 48]