Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-65
SponsorNational Healthcare Group Polyclinics

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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).

  • Usual Care

    Other intervention

    Participants in this arm will receive usual asthma care in primary care that does not involve the use of blood eosinophils

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: Biomarker-Directed ArmActive comparator 1 intervention
Group B: Control Arm (Usual Care)Other 1 intervention

Trial outcomes

Primary outcomes

1

Time 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
2

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
3

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Healthcare Group Polyclinics

Lead sponsor

National Medical Research Council (NMRC), Singapore

Collaborator

Singapore General Hospital

Collaborator