NCT05417906

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

Investigating the Blood Eosinophil Count as a Biomarker to Guide Systemic Corticosteroid Treatment in Hospitalized Exacerbations of Asthma: a Randomized, Controlled, Open-label, Noninferiority Trial

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Changi General Hospital · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Standard care	Oral prednisolone for 5 days
OTHER	Eosinophil-directed care	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

Timeline

• Start date: 2022-06-02
• Primary completion: 2025-09-30
• Completion: 2026-09-30
• First posted: 2022-06-14
• Last updated: 2024-08-21

Locations

2 sites across 1 country: Singapore