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NCT Number: NCT07486401

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

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

Recruiting

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

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

Primary outcomes

  1. Time to first asthma exacerbation requiring hospitalisation

    Time frame: Within 12 months from enrollment

    Time to first asthma exacerbation requiring hospitalisation comparing usual care vs biomarker-directed care measured in days.

  2. Number of asthma exacerbations not requiring hospitalisation

    Time frame: From enrollment to 12 months

    Number of asthma exacerbations not requiring hospitalisation comparing usual care vs biomarker-directed care measured via counts.

  3. Worsening of asthma symptoms

    Time frame: 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 outcomes

  1. Asthma exacerbations requiring systemic corticosteroids and urgent healthcare visits

    Time frame: From enrollment to 12 months

    Asthma exacerbations requiring systemic corticosteroids and urgent healthcare visits (outpatient, ED, admissions) measured via counts.

  2. Change in Asthma Quality of Life Questionnaire score

    Time frame: 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.

  3. Change in Asthma Control Test score

    Time frame: 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.

  4. Change in Global Initiative for Asthma score

    Time frame: 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.

  5. Changes in Forced Expiratory Volume in 1 second

    Time frame: 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.

  6. Changes in Forced Vital Capacity

    Time frame: 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.

  7. Changes in Forced Expiratory Volume in 1 second/Forced Vital Capacity Ratio

    Time frame: 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.

  8. Changes in Peak Expiratory Flow

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Wern Ee Tang

CONTACT

[email protected]

(65) 6355 3000

Sponsors and collaborators

Lead sponsor

National Healthcare Group Polyclinics

Other Gov

Collaborators

  • National Medical Research Council (NMRC), Singapore
  • Singapore General Hospital

Registry information

Official study title

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

Acronym: BEAM

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Mar 20, 2026
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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