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

Primary Purpose

Asthma Attack, Asthma

Status
Recruiting
Phase
Phase 2
Locations
Singapore
Study Type
Interventional
Intervention
Standard care
Eosinophil-directed care
Sponsored by
Changi General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma Attack

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Singapore General HospitalRecruiting
  • Changi General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard care

Eosinophil-directed care

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 29, 2022
Last Updated
November 15, 2022
Sponsor
Changi General Hospital
Collaborators
Singapore General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05417906
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 2, 2022 (Actual)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
September 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changi General Hospital
Collaborators
Singapore General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma Attack, Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard care
Arm Type
Active Comparator
Arm Title
Eosinophil-directed care
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
Oral prednisolone for 5 days
Intervention Type
Other
Intervention Name(s)
Eosinophil-directed care
Intervention Description
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
Primary Outcome Measure Information:
Title
Proportion of participants experiencing treatment failure
Description
Defined as death from any cause, or need for invasive/noninvasive mechanical ventilation, or need to restart/extend systemic steroid treatment
Time Frame
Through the duration of the index admission for asthma attack, typically 3-5 days
Secondary Outcome Measure Information:
Title
Length of hospital stay (number of days)
Time Frame
Through the duration of the index admission for asthma attack, typically 3-5 days
Title
Cumulative steroid dose at index admission (mg prednisolone-equivalent)
Time Frame
Through the duration of the index admission for asthma attack, typically 3-5 days
Title
Proportion of participants receiving additional systemic steroid course within 14 days
Time Frame
14 days
Title
Asthma Control Questionnaire-5
Time Frame
At baseline, 7, 14, 30 and 90 days
Title
Proportion of participants experiencing all-cause death
Time Frame
30 and 90 days
Title
Proportion of participants who develop pneumonia
Time Frame
30 and 90 days
Title
Proportion of participants who develop venous thromboembolism
Time Frame
30 and 90 days
Title
Proportion of participants who develop sepsis
Time Frame
30 and 90 days
Title
Proportion of participants who develop fractures
Time Frame
30 and 90 days
Title
Proportion of participants who develop upper gastrointestinal bleeds/peptic or gastric ulcers
Time Frame
30 and 90 days
Title
Time to next emergency department visit or admission for asthma
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 21 years old Admitted for acute exacerbation of asthma and have received ≤ 3 days of systemic corticosteroids Have a had a blood eosinophil count (as part of routine clinical care) drawn before administration of systemic corticosteroid Have not taken SCS within 7 days prior to presentation to hospital Exclusion Criteria: Concomitant pneumonia Admission to high-dependency/intensive care unit, or requirement for invasive/noninvasive mechanical ventilation Eosinophilia due to other known causes (eosinophilic granulomatosis and polyangiitis, parasitic infections, malignancy) Other concomitant respiratory conditions e.g. chronic obstructive pulmonary disease, bronchiectasis Those on anti-IL5 or anti-IL5R treatment Pregnant subjects 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 Subjects deemed by investigators to have a life expectancy of < 12 months (any cause) Prisoners
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kaori Miranda
Phone
+65 8282 5761
Email
kaori_miranda@cgh.com.sg
First Name & Middle Initial & Last Name or Official Title & Degree
Siti Norashikin binte Fuad
Phone
+65 8044 1939
Email
siti_norashikin_fuad@cgh.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Yii, MB BChir
Organizational Affiliation
Changi General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
168753
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mervyn Ong
Phone
+65 9188 4923
Email
mervyn.ong.h.p@sgh.com.sg
First Name & Middle Initial & Last Name & Degree
Mariko S Koh, MBBS
First Name & Middle Initial & Last Name & Degree
Si Yuan Chew, MBBS
First Name & Middle Initial & Last Name & Degree
Ken CH Lee, MBBS
First Name & Middle Initial & Last Name & Degree
Pei yee Tiew, MBBS
Facility Name
Changi General Hospital
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaori Miranda
Phone
+65 8282 5761
Email
kaori_miranda@cgh.com.sg
First Name & Middle Initial & Last Name & Degree
Siti Norashikin binte Fuad
Phone
+65 8044 1939
Email
siti_norashikin_fuad@cgh.com.sg
First Name & Middle Initial & Last Name & Degree
Anthony Yii, MB BChir
First Name & Middle Initial & Last Name & Degree
Nicole Sieow, MBBS
First Name & Middle Initial & Last Name & Degree
Tunn Ren Tay, MBBS
First Name & Middle Initial & Last Name & Degree
Xue Ning Choo, MBBS
First Name & Middle Initial & Last Name & Degree
Augustine Tee, MBBS

12. IPD Sharing Statement

Plan to Share IPD
No

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

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