About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Biomarker-directed treatment for asthma management
Diagnostic testAsthma management and treatment for participants in this group will be guided by blood eosinophil count (biomarker-directed).
Usual Care
Other interventionParticipants in this arm will receive usual asthma care in primary care that does not involve the use of blood eosinophils
Treatment groups
Trial outcomes
Primary outcomes
Time to first asthma exacerbation requiring hospitalisation
Time to first asthma exacerbation requiring hospitalisation comparing usual care vs biomarker-directed care measured in days.
Number of asthma exacerbations not requiring hospitalisation
Number of asthma exacerbations not requiring hospitalisation comparing usual care vs biomarker-directed care measured via counts.
Worsening of asthma symptoms
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.
Secondary outcomes
Asthma exacerbations requiring systemic corticosteroids and urgent healthcare visits
Asthma exacerbations requiring systemic corticosteroids and urgent healthcare visits (outpatient, ED, admissions) measured via counts.
Change in Asthma Quality of Life Questionnaire score
Change in asthma quality of life questionnaire (AQLQ) score from baseline measure via score points ranging from 1-7, with higher scores indicating better quality of life.
Change in Asthma Control Test score
Change in Asthma Control Test (ACT) scores from baseline measure via score points ranging from 5-25, with higher scores indicating better asthma control.
Change in Global Initiative for Asthma score
Change in Global Initiative for Asthma (GINA) scores from baseline measure via score points ranging from 0-4, with lower scores indicating better asthma control.
Sponsors and contacts
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National Healthcare Group Polyclinics
Lead sponsor
National Medical Research Council (NMRC), Singapore
Collaborator
Singapore General Hospital
Collaborator