Clinical trial NCT05417906: Using the Blood Eosinophil Count to Guide Systemic Corticosteroid Treatment in Asthma Exacerbations
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Asthma Attack
Asthma
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
Collaborators: name: Singapore General Hospital
First posted: 2022-06-14
Enrollment: 110
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of participants experiencing treatment failure
timeFrame: Through the duration of the index admission for asthma attack, typically 3-5 days
Secondary outcomes:
measure: Length of hospital stay (number of days)
timeFrame: Through the duration of the index admission for asthma attack, typically 3-5 days
measure: Cumulative steroid dose at index admission (mg prednisolone-equivalent)
timeFrame: Through the duration of the index admission for asthma attack, typically 3-5 days
measure: Proportion of participants receiving additional systemic steroid course within 14 days
timeFrame: 14 days
measure: Asthma Control Questionnaire-5
timeFrame: At baseline, 7, 14, 30 and 90 days
measure: Proportion of participants experiencing all-cause death
timeFrame: 30 and 90 days
measure: Proportion of participants who develop pneumonia
timeFrame: 30 and 90 days
measure: Proportion of participants who develop venous thromboembolism
timeFrame: 30 and 90 days
measure: Proportion of participants who develop sepsis
timeFrame: 30 and 90 days
measure: Proportion of participants who develop fractures
timeFrame: 30 and 90 days
measure: Proportion of participants who develop upper gastrointestinal bleeds/peptic or gastric ulcers
timeFrame: 30 and 90 days
measure: Time to next emergency department visit or admission for asthma
timeFrame: 1 year
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
affiliation: Changi General Hospital
name: Anthony Yii, MB BChir
role: PRINCIPAL_INVESTIGATOR
References: