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

NCT ID: NCT05417906

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-02
• Study Completion Date: 2026-09-30

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.

Conditions

Asthma Attack; Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard care

Group Type: ACTIVE_COMPARATOR

Standard care

Intervention Type: OTHER

Oral prednisolone for 5 days

Eosinophil-directed care

Group Type: EXPERIMENTAL

Eosinophil-directed care

Intervention Type: OTHER

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

Interventions

Standard care

Oral prednisolone for 5 days

Intervention Type: OTHER

Eosinophil-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

Intervention Type: OTHER

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Singapore General Hospital

OTHER

Sponsor Role: collaborator

Changi General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anthony Yii, MB BChir

Role: PRINCIPAL_INVESTIGATOR

Changi General Hospital

Locations

Singapore General Hospital

Singapore, , Singapore

Changi General Hospital

Singapore, , Singapore

Countries

Singapore

Other Identifiers

03/FY2021/P2/10-A91

Identifier Type: -

Identifier Source: org_study_id