Asthma, Asthma Attack
Conditions
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.
Interventions
OTHERStandard care
Oral prednisolone for 5 days
OTHEREosinophil-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
Sponsors
Singapore General Hospital
Changi General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 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 experiencing all-cause death | 30 and 90 days |
| Proportion of participants who develop pneumonia | 30 and 90 days |
| 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 |
| Proportion of participants who develop fractures | 30 and 90 days |
| Proportion of participants who develop upper gastrointestinal bleeds/peptic or gastric ulcers | 30 and 90 days |
| Time to next emergency department visit or admission for asthma | 1 year |
| Proportion of participants who develop venous thromboembolism | 30 and 90 days |
Countries
Singapore
Outcome results
None listed