- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07486401
Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM) (BEAM)
Randomised Controlled Trial Of 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
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Wern Ee Tang
- Phone Number: (65) 6355 3000
- Email: wern.ee.tang@nhghealth.com.sg
Study Locations
-
-
-
Singapore, Singapore, 308205
- Recruiting
- National Healthcare Group Polyclinics
-
Contact:
- Wern Ee Tang
- Phone Number: (65) 6355 3000
- Email: wern.ee.tang@nhghealth.com.sg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Biomarker-Directed Arm
Asthma management and treatment for participants in this group will be guided by blood eosinophil count (biomarker-directed).
|
Asthma management and treatment for participants in this group will be guided by blood eosinophil count (biomarker-directed).
|
|
Other: Control Arm (Usual Care)
Participants in the control arm will receive usual care, this does not involve the use of blood eosinophils
|
Participants in this arm will receive usual asthma care in primary care that does not involve the use of blood eosinophils
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Within 12 months from enrollment
|
|
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.
|
From enrollment to 12 months
|
|
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.
|
From enrollment to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From enrollment to 12 months
|
|
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.
|
From enrollment to 12 months
|
|
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.
|
From enrollment to 12 months
|
|
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.
|
From enrollment to 12 months
|
|
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.
|
From enrollment to 12 months
|
|
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.
|
From enrollment to 12 months
|
|
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.
|
From enrollment to 12 months
|
|
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.
|
From enrollment to 12 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-4243
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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