Using the Blood Eosinophil Count to Guide Systemic Corticosteroid Treatment in Asthma Exacerbations

NCT05417906 | Active Not Recruiting Phase 2

• 1 other identifier: 03/FY2021/P2/10-A91
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

Brief Summary

Asthma attacks which are moderate-to-severe are typically treated with corticosteroids, but the optimal treatment duration is unknown and treatment responses can be variable. Inadequate treatment may compromise recovery, but increased exposure to corticosteroids is, in turn, associated with drug-related adverse effects. There is a need for a biomarker to guide duration of corticosteroid treatment in asthma attacks. One such candidate biomarker is the blood eosinophil count, which may predict steroid-responsiveness. We hypothesize that the blood eosinophil count can potentially be used as a biomarker to guide the duration of corticosteroids in moderate-to-severe asthma attacks. This study will recruit individuals hospitalized for asthma attack. Participants will be randomized to standard care or blood-eosinophil guided systemic corticosteroid therapy. Subjects in the standard arm will receive oral corticosteroids for a total of 5 days. Subjects in the blood-eosinophil guided arm will receive oral corticosteroids for a total of 5 days if admission eosinophil count is ≥ 0.300 x 10\^3/µL, and receive 3 days of oral corticosteroids if the admission blood eosinophil is \< 0.300 x 10\^3/µL. The rate of treatment failure will be compared between these two groups.

Conditions

Asthma Attack; Asthma

Outcome Measures

Primary Outcomes (1)

• Proportion of participants experiencing treatment failure

  Defined as death from any cause, or need for invasive/noninvasive mechanical ventilation, or need to restart/extend systemic steroid treatment

  Through the duration of the index admission for asthma attack, typically 3-5 days

Secondary Outcomes (11)

• Length of hospital stay (number of days)

  Through the duration of the index admission for asthma attack, typically 3-5 days

• Cumulative steroid dose at index admission (mg prednisolone-equivalent)

  Through the duration of the index admission for asthma attack, typically 3-5 days

• Proportion of participants receiving additional systemic steroid course within 14 days

  14 days

• Asthma Control Questionnaire-5

  At baseline, 7, 14, 30 and 90 days

• Proportion of participants experiencing all-cause death

  30 and 90 days

Study Arms (2)

Standard care

ACTIVE COMPARATOR

Other: Standard care

Eosinophil-directed care

EXPERIMENTAL

Other: Eosinophil-directed care

Interventions

Standard care OTHER

Oral prednisolone for 5 days

Standard care

Eosinophil-directed care OTHER

Oral prednisolone for 5 days if eosinophil count is ≥ 0.300 x 10\^3/µL, or 3 days if eosinophil is \< 0.300 x 10\^3/µL

Eosinophil-directed care

Eligibility Criteria

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

You may qualify if:

• Age ≥ 21 years old
• Admitted for acute exacerbation of asthma and have received ≤ 3 days of systemic corticosteroids
• Have a had a blood eosinophil count (as part of routine clinical care) drawn before administration of systemic corticosteroid
• Have not taken SCS within 7 days prior to presentation to hospital

You may not qualify if:

• Concomitant pneumonia
• Admission to high-dependency/intensive care unit, or requirement for invasive/noninvasive mechanical ventilation
• Eosinophilia due to other known causes (eosinophilic granulomatosis and polyangiitis, parasitic infections, malignancy)
• Other concomitant respiratory conditions e.g. chronic obstructive pulmonary disease, bronchiectasis
• Those on anti-IL5 or anti-IL5R treatment
• Pregnant subjects
• Subjects who are already on an investigational drug or has been participating in another clinical study with an investigational product within the last 6 months
• Subjects deemed by investigators to have a life expectancy of \< 12 months (any cause)
• Prisoners

Sponsors & Collaborators

• Changi General Hospital: lead
• Singapore General Hospital: collaborator

Study Sites (2)

Singapore General Hospital

Singapore, 168753, Singapore

Location

Changi General Hospital

Singapore, 529889, Singapore

Location

Related Publications (1)

• Yii A, Tay TR, Lee KCH, Chew SY, Sieow NY, Choo XN, Toh MR, Loh SCH, Tiew PY, Koh JMK, Tee AKH, Koh MS. Blood eosinophil-guided systemic corticosteroid duration in adults hospitalised for asthma exacerbation: a randomised, controlled, open-label, non-inferiority trial. Thorax. 2025 Dec 3:thorax-2025-223961. doi: 10.1136/thorax-2025-223961. Online ahead of print.

  PMID: 41339088 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Anthony Yii, MB BChir

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2022
• First Posted: June 14, 2022
• Study Start: June 2, 2022
• Primary Completion: September 30, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)