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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05417906
Other study ID # 03/FY2021/P2/10-A91
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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