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

Phase 2

Active, not recruiting

• Conditions: Asthma Attack; Asthma

• Registration Number: NCT05417906
• Lead Sponsor: Changi General Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-5-29
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Age = 21 years old<br><br> 2. Admitted for acute exacerbation of asthma and have received = 3 days of systemic<br> corticosteroids<br><br> 3. Have a had a blood eosinophil count (as part of routine clinical care) drawn before<br> administration of systemic corticosteroid<br><br> 4. Have not taken SCS within 7 days prior to presentation to hospital<br><br>Exclusion Criteria:<br><br> 1. Concomitant pneumonia<br><br> 2. Admission to high-dependency/intensive care unit, or requirement for<br> invasive/noninvasive mechanical ventilation<br><br> 3. Eosinophilia due to other known causes (eosinophilic granulomatosis and<br> polyangiitis, parasitic infections, malignancy)<br><br> 4. Other concomitant respiratory conditions e.g. chronic obstructive pulmonary disease,<br> bronchiectasis<br><br> 5. Those on anti-IL5 or anti-IL5R treatment<br><br> 6. Pregnant subjects<br><br> 7. Subjects who are already on an investigational drug or has been participating in<br> another clinical study with an investigational product within the last 6 months<br><br> 8. Subjects deemed by investigators to have a life expectancy of < 12 months (any<br> cause)<br><br> 9. Prisoners

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of participants experiencing treatment failure

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay (number of days);Cumulative steroid dose at index admission (mg prednisolone-equivalent);Proportion of participants receiving additional systemic steroid course within 14 days;Asthma Control Questionnaire-5;Proportion of participants experiencing all-cause death;Proportion of participants who develop pneumonia;Proportion of participants who develop venous thromboembolism;Proportion of participants who develop sepsis;Proportion of participants who develop fractures;Proportion of participants who develop upper gastrointestinal bleeds/peptic or gastric ulcers;Time to next emergency department visit or admission for asthma