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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05417906
• Other study ID #: 03/FY2021/P2/10-A91
• Status: Recruiting
• Phase: Phase 2
• Start date: June 2, 2022
• Est. completion date: September 30, 2026

Study information

• Verified date: November 2022
• Source: Changi General Hospital
• Contact: Kaori Miranda
• Phone: +65 8282 5761
• Email: kaori_miranda[@]cgh.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: September 30, 2026
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma Attack

Intervention

Other:
• Standard care
Oral prednisolone for 5 days
• 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

Locations

Country	Name	City	State
Singapore	Changi General Hospital	Singapore
Singapore	Singapore General Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Changi General Hospital	Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Through the duration of the index admission for asthma attack, typically 3-5 days
Secondary	Length of hospital stay (number of days)		Through the duration of the index admission for asthma attack, typically 3-5 days
Secondary	Cumulative steroid dose at index admission (mg prednisolone-equivalent)		Through the duration of the index admission for asthma attack, typically 3-5 days
Secondary	Proportion of participants receiving additional systemic steroid course within 14 days		14 days
Secondary	Asthma Control Questionnaire-5		At baseline, 7, 14, 30 and 90 days
Secondary	Proportion of participants experiencing all-cause death		30 and 90 days
Secondary	Proportion of participants who develop pneumonia		30 and 90 days
Secondary	Proportion of participants who develop venous thromboembolism		30 and 90 days
Secondary	Proportion of participants who develop sepsis		30 and 90 days
Secondary	Proportion of participants who develop fractures		30 and 90 days
Secondary	Proportion of participants who develop upper gastrointestinal bleeds/peptic or gastric ulcers		30 and 90 days
Secondary	Time to next emergency department visit or admission for asthma		1 year