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

Phase 2

Active, not recruiting

• Conditions: Asthma; Asthma Attack
• Interventions: Other: Standard care; Other: Eosinophil-directed care

• Registration Number: NCT05417906
• Lead Sponsor: Changi General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-29
• Study Start: 2022-06-02
• Study First Submitted QC: 2022-06-09
• Study First Posted: 2022-06-14
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-21
• Primary Completion: 2025-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

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

Exclusion Criteria

1. Concomitant pneumonia
2. Admission to high-dependency/intensive care unit, or requirement for invasive/noninvasive mechanical ventilation
3. Eosinophilia due to other known causes (eosinophilic granulomatosis and polyangiitis, parasitic infections, malignancy)
4. Other concomitant respiratory conditions e.g. chronic obstructive pulmonary disease, bronchiectasis
5. Those on anti-IL5 or anti-IL5R treatment
6. Pregnant subjects
7. 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
8. Subjects deemed by investigators to have a life expectancy of < 12 months (any cause)
9. Prisoners

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard care	Standard care	-
Eosinophil-directed care	Eosinophil-directed care	-

Primary Outcome Measures

Name	Time	Method
Proportion of participants experiencing treatment failure	Through the duration of the index admission for asthma attack, typically 3-5 days	Defined as death from any cause, or need for invasive/noninvasive mechanical ventilation, or need to restart/extend systemic steroid treatment

Secondary Outcome Measures

Name	Time	Method
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 who develop venous thromboembolism	30 and 90 days
Proportion of participants who develop upper gastrointestinal bleeds/peptic or gastric ulcers	30 and 90 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 who develop pneumonia	30 and 90 days
Proportion of participants experiencing all-cause death	30 and 90 days
Proportion of participants who develop fractures	30 and 90 days
Time to next emergency department visit or admission for asthma	1 year
Length of hospital stay (number of days)	Through the duration of the index admission for asthma attack, typically 3-5 days
Proportion of participants who develop sepsis	30 and 90 days

Trial Locations

Locations (2)

Singapore General Hospital; 🇸🇬 Singapore, Singapore

Changi General Hospital; 🇸🇬 Singapore, Singapore