Asthma AttackPhase 2NCT05417906
Using the Blood Eosinophil Count to Guide Systemic Corticosteroid Treatment in Asthma Exacerbations
A Phase 2 study testing Eosinophil-directed care in people with Asthma Attack and Asthma, run by Changi General Hospital at 2 sites in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Asthma Attack, Asthma
- What is being tested?
- Eosinophil-directed care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesSingapore
- Study dates
- 2 Jun 2022to 30 Sep 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
Singapore General Hospital
Singapore, 168753
Changi General Hospital
Singapore, 529889
About this study
Official title: 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
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
- Being tested
- Standard care, Eosinophil-directed care
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard careOther
Oral prednisolone for 5 days
Eosinophil-directed careOther
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
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Active comparator | Not described Receives: Other: Standard care |
| Eosinophil-directed care | Experimental | Not described Receives: Other: Eosinophil-directed care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through the duration of the index admission for asthma attack, typically 3-5 days
Secondary outcomes (11)
Length of hospital stay (number of days)
Measured: Through the duration of the index admission for asthma attack, typically 3-5 days
Cumulative steroid dose at index admission (mg prednisolone-equivalent)
Measured: 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
Measured: 14 days
Asthma Control Questionnaire-5
Measured: At baseline, 7, 14, 30 and 90 days
Proportion of participants experiencing all-cause death
Measured: 30 and 90 days
Proportion of participants who develop pneumonia
Measured: 30 and 90 days
Proportion of participants who develop venous thromboembolism
Measured: 30 and 90 days
Proportion of participants who develop sepsis
Measured: 30 and 90 days
Proportion of participants who develop fractures
Measured: 30 and 90 days
Proportion of participants who develop upper gastrointestinal bleeds/peptic or gastric ulcers
Measured: 30 and 90 days
Time to next emergency department visit or admission for asthma
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start2 Jun 2022
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asthma AttackStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore General Hospital
- Responsible party
- Sponsor
- Investigators
- Anthony Yii, MB BChir, Principal investigator, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417906
- Sponsor's protocol ID
- 03/FY2021/P2/10-A91
- Status last verified
- Aug 2024
- First submitted
- 29 May 2022
- Last updated
- 21 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. 2026 Feb 16;81(3):238-245. doi: 10.1136/thorax-2025-223961.
PubMed 41339088