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NCT05417906CompletedPhase 2

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

Source: ClinicalTrials.gov · Last updated 28 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
110 (actual)
First submitted
29 May 2022
Start date
2 Jun 2022
Primary completion date
19 May 2024
Lead sponsor
Changi General Hospital
Diseases
Asthma
NCT number
NCT05417906

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 110
  • From 2 Jun 2022 to the primary completion date, 19 May 2024
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concomitant pneumonia
  • Other concomitant respiratory conditions e.g. chronic obstructive pulmonary disease, bronchiectasis
  • 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

Other illness

  • Eosinophilia due to other known causes (eosinophilic granulomatosis and polyangiitis, parasitic infections, malignancy)

Other

  • Admission to high-dependency/intensive care unit, or requirement for invasive/noninvasive mechanical ventilation
  • Those on anti-IL5 or anti-IL5R treatment
  • Pregnant subjects
  • Subjects deemed by investigators to have a life expectancy of \< 12 months (any cause)
  • Prisoners

Who the study is looking for

  • 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

Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Changi General Hospital
Coordinator of this site? Confirm its status
SingaporeSingaporeUnknown status
Singapore General Hospital
Coordinator of this site? Confirm its status
SingaporeSingaporeUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.