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

StatusUnknown
PhasePhase 2
Started

Record status This record was last updated August 21, 2024 (before its estimated September 30, 2025 completion). Its status may not reflect the trial's current state.

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Record History

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  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Aug 2024); last known: Active, Not Recruiting
  2. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 2 of 2 sites
    v3
  3. Notable Primary endpoint revised
    • Start date changed from estimate of Jun 2022 to Jun 2, 2022
    v2
  4. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05417906
Lead Sponsor Changi General Hospital
Collaborators: Singapore General Hospital
Conditions
(from sponsor)
Asthma Attack, Asthma
Related terms Asthma
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov