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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
Asthma management and treatment for participants in this group will be guided by blood eosinophil count (biomarker-directed).
Participants in this arm will receive usual asthma care in primary care that does not involve the use of blood eosinophils
National Healthcare Group Polyclinics
Singapore, Singapore
RECRUITINGTime to first asthma exacerbation requiring hospitalisation
Time to first asthma exacerbation requiring hospitalisation comparing usual care vs biomarker-directed care measured in days.
Time frame: Within 12 months from enrollment
Number of asthma exacerbations not requiring hospitalisation
Number of asthma exacerbations not requiring hospitalisation comparing usual care vs biomarker-directed care measured via counts.
Time frame: From enrollment to 12 months
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.
Time frame: From enrollment to 12 months
Asthma exacerbations requiring systemic corticosteroids and urgent healthcare visits
Asthma exacerbations requiring systemic corticosteroids and urgent healthcare visits (outpatient, ED, admissions) measured via counts.
Time frame: From enrollment to 12 months
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.
Time frame: From enrollment to 12 months
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.
Time frame: From enrollment to 12 months
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.
Time frame: From enrollment to 12 months
Changes in Forced Expiratory Volume in 1 second
Changes in Forced Expiratory Volume in 1 second (FEV1) from spirometry test, measured in litres, percentages and litres per second. Lower FEV1 value indicates lung obstruction.
Time frame: From enrollment to 12 months
Changes in Forced Vital Capacity
Changes in Forced Vital Capacity (FVC) from spirometry test, measured in litres, percentages and litres per second. Lower FVC value indicates lung obstruction.
Time frame: From enrollment to 12 months
Changes in Forced Expiratory Volume in 1 second/Forced Vital Capacity Ratio
Changes in Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) ratio from spirometry test, measured in litres, percentages and litres per second. FEV1/FVC below 0.70 typically indicates airway obstruction.
Time frame: From enrollment to 12 months
Changes in Peak Expiratory Flow
Changes in Peak Expiratory Flow (PEF) from spirometry test, measured in litres, percentages and litres per second. Higher PEF value indicates good asthma control.
Time frame: From enrollment to 12 months
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