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

NCT07486401 | Recruiting

• 1 other identifier: 2024-4243
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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

Conditions

Asthma Exacerbations; Biomarkers / Blood; Eosinophil Blood Count

Keywords

Asthma; Mild-moderate Asthma; Blood Biomarkers; Eosinophil; Primary Care

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (8)

• Asthma exacerbations requiring systemic corticosteroids and urgent healthcare visits

  From enrollment to 12 months

• Change in Asthma Quality of Life Questionnaire score

  From enrollment to 12 months

• Change in Asthma Control Test score

  From enrollment to 12 months

• Change in Global Initiative for Asthma score

  From enrollment to 12 months

• Changes in Forced Expiratory Volume in 1 second

  From enrollment to 12 months

Study Arms (2)

Biomarker-Directed Arm

ACTIVE COMPARATOR

Asthma management and treatment for participants in this group will be guided by blood eosinophil count (biomarker-directed).

Diagnostic Test: Biomarker-directed treatment for asthma management

Control Arm (Usual Care)

OTHER

Participants in the control arm will receive usual care, this does not involve the use of blood eosinophils

Other: Usual Care

Interventions

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).

Biomarker-Directed Arm

Usual Care OTHER

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

Control Arm (Usual Care)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• No asthma exacerbations\* in the preceding 4 weeks before randomisation
• Able and willing to attend study appointments approximately every 4-monthly over a 1-year period
• Able to provide informed consent
• 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

You may not qualify if:

• 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
• Current use of beta-blocking agents including eye-drops
• Use of oral, rectal, or parenteral glucocorticoid within 30 days and/or depot parenteral glucocorticoid within 12 weeks prior to recruitment
• Known diagnosis of Chronic Obstructive Pulmonary Disease, Interstitial lung disease or bronchiectasis
• 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
• Current enrolment in other interventional clinical trial for asthma
• Female subjects who are pregnant or planning pregnancy during the study period
• Planned travel outside of the country for ≥16 consecutive weeks during the study
• Investigator's assessment of poor capability of following study instructions or comply with study procedures

Sponsors & Collaborators

• National Healthcare Group Polyclinics: lead
• National Medical Research Council (NMRC), Singapore: collaborator
• Singapore General Hospital: collaborator

Study Sites (1)

National Healthcare Group Polyclinics

Singapore, 308205, Singapore

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Wern Ee Tang

CONTACT

(65) 6355 3000; wern.ee.tang@nhghealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Family Physician, Senior Consultant

Model Details: 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.

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: March 20, 2026
• Study Start: December 3, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)