Randomised Controlled Trial Of Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Time to first asthma exacerbation requiring hospitalisation
研究概览
简要总结
The aim of this study is to evaluate usual care versus biomarker-directed care (using blood eosinophil counts) for the management of asthma patients in primary care setting.
The study hypothesizes that BEC is a valuable biomarker that can guide asthma treatment, and result in reduction in asthma exacerbations, better symptom control and improvement in quality of life compared to usual arm in mild to moderate asthma patients in the primary care setting.
Researchers would compare using blood eosinophil count guided to usual care to see if biomarker-directed asthma treatment and management
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Singaporeans or Singapore Permanent Residents
- •Patients aged ≥21 to 65 years old
- •Physician diagnosed asthma for duration of at least 4 weeks
- •On or will be initiated on Global Initiative for Asthma (GINA) 2025 step 1-3) treatment
- •No asthma exacerbations* in the preceding 4 weeks before randomisation
- •Able and willing to attend study appointments approximately every 4-monthly over a 1-year period
- •Able to provide informed consent
- •Stable cardiovascular status (i.e. controlled hypertension, no active symptoms of heart disease or arrhythmias) *Exacerbations are defined as worsening of asthma symptoms requiring systemic corticosteroid for 3 or more days, emergency department visit, or hospitalization
排除标准
- •History of life-threatening asthma requiring intubation or intensive care unit admission
- •Severe asthma or difficult to treat asthma
- •Current use of long-term immunosuppression, LTRA receptor antagonist (Montelukast) and Theophylline or long-term oral steroids
- •Presence of other known causes of eosinophilia besides asthma (e.g. parasitic infection), based on physician's discretion and investigation as per clinical practice and suspicion
- •Current use of beta-blocking agents including eye-drops
- •Use of oral, rectal, or parenteral glucocorticoid within 30 days and/or depot parenteral glucocorticoid within 12 weeks prior to recruitment
- •Known diagnosis of Chronic Obstructive Pulmonary Disease, Interstitial lung disease or bronchiectasis
- •Any significant disease or disorder (eg. Cardiovascular, pulmonary other than asthma, gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the investigator, may either 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 participate in the study
- •Current enrolment in other interventional clinical trial for asthma
- •Female subjects who are pregnant or planning pregnancy during the study period
- •Planned travel outside of the country for ≥16 consecutive weeks during the study
- •Investigator's assessment of poor capability of following study instructions or comply with study procedures
结局指标
主要结局
Time to first asthma exacerbation requiring hospitalisation
时间窗: Within 12 months from enrollment
Time to first asthma exacerbation requiring hospitalisation comparing usual care vs biomarker-directed care measured in days.
Number of asthma exacerbations not requiring hospitalisation
时间窗: From enrollment to 12 months
Number of asthma exacerbations not requiring hospitalisation comparing usual care vs biomarker-directed care measured via counts.
Worsening of asthma symptoms
时间窗: From enrollment to 12 months
Worsening of asthma symptoms based on Asthma Control Test Score (ACT score decrease ≥3 points from baseline) comparing usual care vs biomarker-directed care measured based on scores and percentage of scores.
次要结局
- Asthma exacerbations requiring systemic corticosteroids and urgent healthcare visits(From enrollment to 12 months)
- Change in Asthma Quality of Life Questionnaire score(From enrollment to 12 months)
- Change in Asthma Control Test score(From enrollment to 12 months)
- Change in Global Initiative for Asthma score(From enrollment to 12 months)
- Changes in Forced Expiratory Volume in 1 second(From enrollment to 12 months)
- Changes in Forced Vital Capacity(From enrollment to 12 months)
- Changes in Forced Expiratory Volume in 1 second/Forced Vital Capacity Ratio(From enrollment to 12 months)
- Changes in Peak Expiratory Flow(From enrollment to 12 months)
研究者
Wern Ee Tang
Family Physician, Senior Consultant
National Healthcare Group Polyclinics