Asthma Exacerbations, Biomarkers / Blood, Eosinophil Blood Count
Conditions
Keywords
Asthma, Mild-moderate Asthma, Blood Biomarkers, Eosinophil, Primary Care
Brief summary
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
Interventions
DIAGNOSTIC_TESTBiomarker-directed treatment for asthma management
Asthma management and treatment for participants in this group will be guided by blood eosinophil count (biomarker-directed).
OTHERUsual Care
Participants in this arm will receive usual asthma care in primary care that does not involve the use of blood eosinophils
Sponsors
National Healthcare Group Polyclinics
National Medical Research Council (NMRC), Singapore
Singapore General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study aims to evaluate the feasibility of using blood eosinophil as a biomarker-directed treatment for the management of mid-moderate asthmatic patients in primary care.
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Singaporeans or Singapore Permanent Residents 2. Patients aged ≥21 to 65 years old 3. Physician diagnosed asthma for duration of at least 4 weeks 4. On or will be initiated on Global Initiative for Asthma (GINA) 2025 step 1-3) treatment 5. No asthma exacerbations\* in the preceding 4 weeks before randomisation 6. Able and willing to attend study appointments approximately every 4-monthly over a 1-year period 7. Able to provide informed consent 8. 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
Exclusion criteria
1. History of life-threatening asthma requiring intubation or intensive care unit admission 2. Severe asthma or difficult to treat asthma 3. Current use of long-term immunosuppression, LTRA receptor antagonist (Montelukast) and Theophylline or long-term oral steroids 4. 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 5. Current use of beta-blocking agents including eye-drops 6. Use of oral, rectal, or parenteral glucocorticoid within 30 days and/or depot parenteral glucocorticoid within 12 weeks prior to recruitment 7. Known diagnosis of Chronic Obstructive Pulmonary Disease, Interstitial lung disease or bronchiectasis 8. 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 9. Current enrolment in other interventional clinical trial for asthma 10. Female subjects who are pregnant or planning pregnancy during the study period 11. Planned travel outside of the country for ≥16 consecutive weeks during the study 12. Investigator's assessment of poor capability of following study instructions or comply with study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first asthma exacerbation requiring hospitalisation | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Asthma exacerbations requiring systemic corticosteroids and urgent healthcare visits | From enrollment to 12 months | Asthma exacerbations requiring systemic corticosteroids and urgent healthcare visits (outpatient, ED, admissions) measured via counts. |
| Change in Asthma Quality of Life Questionnaire score | From enrollment to 12 months | 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 | From enrollment to 12 months | 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 | From enrollment to 12 months | 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. |
| Changes in Forced Expiratory Volume in 1 second | From enrollment to 12 months | 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. |
| Changes in Forced Vital Capacity | From enrollment to 12 months | Changes in Forced Vital Capacity (FVC) from spirometry test, measured in litres, percentages and litres per second. Lower FVC value indicates lung obstruction. |
| Changes in Forced Expiratory Volume in 1 second/Forced Vital Capacity Ratio | From enrollment to 12 months | 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. |
| Changes in Peak Expiratory Flow | From enrollment to 12 months | Changes in Peak Expiratory Flow (PEF) from spirometry test, measured in litres, percentages and litres per second. Higher PEF value indicates good asthma control. |
Countries
Singapore
Contacts
CONTACTWern Ee Tang
Outcome results
None listed