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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
540
The 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).
Northan Jiangsu People's Hospital
Yangzhou, China
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
Time frame: Week 24
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
Time frame: Week 48
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
Time frame: Week48
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
Time frame: Baseline, week 48
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
Time frame: 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
To evaluate the effect of GDMT education on asthma control
Time frame: 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
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To evaluate the effect of GDMT education on asthma control
Time frame: 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
To evaluate the effect of GDMT education on asthma control
Time frame: Week 48
The proportion of participants achieved ACT MCID (ACT improvement ≥3 points) in the intervention group at Week 24 and 48
To evaluate the effect of GDMT education on asthma control
Time frame: 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
To evaluate the effect of GDMT education on pulmonary function
Time frame: Week 48
Change in pre-bronchodilator FEV1 (Pre-BD FEV1) from baseline in the intervention group at Week 24 and 48
To evaluate the effect of GDMT education on pulmonary function
Time frame: 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
To evaluate the effect of GDMT education on pulmonary function
Time frame: Week 48
Difference in St. George's Respiratory Questionnaire (SGRQ) scores (total and domain scores) between the intervention and control groups at Week 48
To evaluate the effect of GDMT education on quality of life
Time frame: Week 48
Change in SGRQ scores from baseline in the intervention group at Week 24 and Week 48
To evaluate the effect of GDMT education on quality of life
Time frame: Baseline, week 24, week 48
Difference in the proportion of participants who achieved SGRQ MCID (decrease in total score ≥4 points) between the intervention and control groups at Week 48
To evaluate the effect of GDMT education on quality of life
Time frame: Week 48
The proportion of participants achieved SGRQ MCID (decrease in total score ≥4 points) in the intervention group at Week 24 and 48
To evaluate the effect of GDMT education on quality of life
Time frame: Week 24, week 48
Difference in the proportion of participants with a written diagnosis of "Severe Asthma" between the intervention and control groups at Week 48
To evaluate the effect of GDMT education on diagnosis rate
Time frame: Week 48
Difference in the time to written diagnosis of "Severe Asthma" between the intervention and control groups during the 48-week study period;
To evaluate the effect of GDMT education on diagnosis rate
Time frame: During the 48-week study period
Reasons for not meeting the diagnostic criteriac for severe asthma among participants in the intervention group not diagnosed with "severe asthma" at Week 48
To evaluate the effect of GDMT education on diagnosis rate
Time frame: Week 48
Difference in the proportion of participants with peripheral blood eosinophil (bEOS) test records within the past 3 months, excluding those during asthma exacerbation, between the intervention and control groups at Week 24 and 48
To evaluate the effect of GDMT education on biomarkers tests rate
Time frame: Week 24, week 48
Difference in the proportion of participants with Fractional exhaled Nitric Oxide (FeNO) test records within the past 3 months between the intervention and control groups at Week 24 and 48
To evaluate the effect of GDMT education on biomarkers tests rate
Time frame: Week 24, week 48
Difference in the proportion of participants with Immunoglobulin E (IgE) test records within the past 3 months between the intervention and control groups at Week 24 and 48
To evaluate the effect of GDMT education on biomarkers tests rate
Time frame: Week 24, week 48
Difference in the cumulative number of bEOS test records between the intervention and control groups during the 48-week study period
To evaluate the effect of GDMT education on biomarkers tests rate
Time frame: During the 48-week study period
Difference in the cumulative number of IgE test records between the intervention and control groups during the 48-week study period
To evaluate the effect of GDMT education on biomarkers tests rate
Time frame: During the 48-week study period
Difference in the cumulative number of FeNO test records between the intervention and control groups during the 48-week study period
To evaluate the effect of GDMT education on biomarkers tests rate
Time frame: During the 48-week study period
Difference in the proportion of participants with typing records between the intervention and control groups over the 48-week study period
To evaluate the effect of GDMT education on typing records
Time frame: Week 48
Difference in the time to first asthma typing record between the intervention and control groups during the 48-week study period
To evaluate the effect of GDMT education on typing records
Time frame: During the 48-week study period
Difference in the proportion of participants with record of eosinophilic asthma phenotype between the intervention and control groups over the 48-week study period
To evaluate the effect of GDMT education on typing records
Time frame: Week 48
Difference in the time to first eosinophilic asthma phenotype record between the intervention and control groups during the 48-week study period
To evaluate the effect of GDMT education on typing records
Time frame: During the 48-week study period
Difference in the proportion of participants with a recorded Type 2 (T2) asthma phenotype between the intervention and control groups during the 48-week study period
To evaluate the effect of GDMT education on typing records
Time frame: Week 48
Difference in the proportion of participants with record of allergic asthma phenotype between the intervention and control groups during the 48-week study period
To evaluate the effect of GDMT education on typing records
Time frame: Week 48
Difference in the cumulative number of pulmonary function test records between the intervention and control groups during the 48-week study period
To evaluate the effect of GDMT education on pulmonary function test utilization
Time frame: Week 48
Difference in the proportion of participants using biologics between the intervention and control groups during the 48-week study period
To evaluate the effect of GDMT education on biologic utilization
Time frame: Week 48
Difference in the duration of biologic use between the intervention and control groups
To evaluate the effect of GDMT education on biologic utilization
Time frame: During the 48-week study period
Distribution of different treatment pattern in the intervention group during the 48-week study period
To evaluate the effect of GDMT education on treatment pattern
Time frame: During the 48-week study period
Distribution of different treatment pattern in the control group at Week 48
To evaluate the effect of GDMT education on treatment pattern
Time frame: Week 48
Difference in the proportion of participants regularly completing scheduled follow-ups visitse between the intervention and control groups over the 48-week study period
To evaluate the effect of GDMT education on regular follow-up visits
Time frame: Week 48
Difference in the drop-out rate between the intervention and control groups at Week 48
To evaluate the effect of GDMT education on regular follow-up visits
Time frame: Week 48
Subgroup analyses will be conducted as appropriate; planned subgroups to explore include: Hospital classification, Participant classification.
Describe the differences in physician behavior, participant benefit, and healthcare resource conservation across different hospital and participant subgroups after GDMT education
Time frame: During the 48-week study period