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| Name | Class |
|---|---|
| National Medical Research Council (NMRC), Singapore | OTHER_GOV |
| Singapore General Hospital | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biomarker-Directed Arm | Active Comparator | Asthma management and treatment for participants in this group will be guided by blood eosinophil count (biomarker-directed). |
|
| Control Arm (Usual Care) | Other | Participants in the control arm will receive usual care, this does not involve the use of blood eosinophils |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biomarker-directed treatment for asthma management | Diagnostic Test | Asthma management and treatment for participants in this group will be guided by blood eosinophil count (biomarker-directed). |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first asthma exacerbation requiring hospitalisation | Time to first asthma exacerbation requiring hospitalisation comparing usual care vs biomarker-directed care measured in days. | 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. | 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. | From enrollment to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma exacerbations requiring systemic corticosteroids and urgent healthcare visits | Asthma exacerbations requiring systemic corticosteroids and urgent healthcare visits (outpatient, ED, admissions) measured via counts. | From enrollment to 12 months |
| Change in Asthma Quality of Life Questionnaire score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wern Ee Tang | Contact | (65) 6355 3000 | wern.ee.tang@nhghealth.com.sg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Healthcare Group Polyclinics | Recruiting | Singapore | 308205 | Singapore |
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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.
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| Usual Care | Other | Participants in this arm will receive usual asthma care in primary care that does not involve the use of blood eosinophils |
|
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. |
| 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. | 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. | 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. | 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. | 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. | 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. | From enrollment to 12 months |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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