A Prospective, Multicenter, Cluster-Randomized Trial to Evaluate the Impact of Guideline-Directed Medical Therapy in Uncontrolled Asthma Patients Receiving Medium-to-High Dose Inhaled Corticosteroids Plus Long-acting β2 Agonist
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- AstraZeneca
- 入组人数
- 540
- 试验地点
- 1
- 主要终点
- Difference in the proportion of participants with a written diagnosis of "Severe Asthma" between the intervention and control groups at Week 24
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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;
- •Experienced one or more exacerbations within the past year;
- •Exacerbation is defined as meeting any of the following criteria:
- •Use of systemic corticosteroids (or a temporary increase in the stable dose of baseline oral corticosteroids) for at least 3 days; a single injection of a depot long-acting corticosteroid can be considered equivalent to a 3-day course of systemic corticosteroids;
- •An emergency department or urgent care site visit for asthma (defined as being evaluated and treated in the emergency department or urgent care site for < 24 hours) requiring the use of systemic corticosteroids for at least 3 days (as described above);
- •Hospitalization for asthma (defined as admission to a hospital and/or being evaluated and treated in a healthcare facility for ≥ 24 hours).
排除标准
- •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;
- •Using systemic glucocorticoids for other diseases;
- •History of respiratory tract infection within 4 weeks prior to Visit 0 (upper respiratory tract infections and lower respiratory tract infections);
- •Any significant disease or disorder (e.g., cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine/metabolic, malignant, psychiatric, or significant physical impairment, etc.) which, in the opinion of the investigator, may put the patient at risk because of participation in the study, or may influence the results of the study, or the patient's ability to comply with GDMT.
结局指标
主要结局
Difference in the proportion of participants with a written diagnosis of "Severe Asthma" between the intervention and control groups at Week 24
时间窗: 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
时间窗: Week 48
To evaluate the effect of GDMT education on asthma exacerbations
次要结局
- Difference in the proportion of participants with asthma exacerbation between the intervention and control groups at Week 48(Week48)
- Difference in the change in mean ACT score from baseline between the intervention and control groups at Week 48(Baseline, week 48)
- Change in mean ACT score from baseline in the intervention group at Week 24 and 48(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(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(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(Week 48)
- The proportion of participants achieved ACT MCID (ACT improvement ≥3 points) in the intervention group at Week 24 and 48(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(Week 48)
- Change in pre-bronchodilator FEV1 (Pre-BD FEV1) from baseline in the intervention group at Week 24 and 48(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(Week 48)
- Difference in St. George's Respiratory Questionnaire (SGRQ) scores (total and domain scores) between the intervention and control groups at Week 48(Week 48)
- Change in SGRQ scores from baseline in the intervention group at Week 24 and Week 48(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(Week 48)
- The proportion of participants achieved SGRQ MCID (decrease in total score ≥4 points) in the intervention group at Week 24 and 48(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(Week 48)
- Difference in the time to written diagnosis of "Severe Asthma" between the intervention and control groups during the 48-week study period;(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(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(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(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(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(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(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(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(Week 48)
- Difference in the time to first asthma typing record between the intervention and control groups during the 48-week study period(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(Week 48)
- Difference in the time to first eosinophilic asthma phenotype record between the intervention and control groups during the 48-week study period(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(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(Week 48)
- Difference in the cumulative number of pulmonary function test records between the intervention and control groups during the 48-week study period(Week 48)
- Difference in the proportion of participants using biologics between the intervention and control groups during the 48-week study period(Week 48)
- Difference in the duration of biologic use between the intervention and control groups(During the 48-week study period)
- Distribution of different treatment pattern in the intervention group during the 48-week study period(During the 48-week study period)
- Distribution of different treatment pattern in the control group at Week 48(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(Week 48)
- Difference in the drop-out rate between the intervention and control groups at Week 48(Week 48)
- Subgroup analyses will be conducted as appropriate; planned subgroups to explore include: Hospital classification, Participant classification.(During the 48-week study period)