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NCT Number: NCT05417906

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Asthma Attack Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Changi General Hospital, Singapore

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard care

Other

Oral prednisolone for 5 days

Eosinophil-directed care

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

Primary outcomes

  1. Proportion of participants experiencing treatment failure

    Time frame: Through the duration of the index admission for asthma attack, typically 3-5 days

    Defined as death from any cause, or need for invasive/noninvasive mechanical ventilation, or need to restart/extend systemic steroid treatment

Secondary outcomes

  1. Length of hospital stay (number of days)

    Time frame: Through the duration of the index admission for asthma attack, typically 3-5 days

  2. 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

  3. Proportion of participants receiving additional systemic steroid course within 14 days

    Time frame: 14 days

  4. Asthma Control Questionnaire-5

    Time frame: At baseline, 7, 14, 30 and 90 days

  5. Proportion of participants experiencing all-cause death

    Time frame: 30 and 90 days

  6. Proportion of participants who develop pneumonia

    Time frame: 30 and 90 days

  7. Proportion of participants who develop venous thromboembolism

    Time frame: 30 and 90 days

  8. Proportion of participants who develop sepsis

    Time frame: 30 and 90 days

  9. Proportion of participants who develop fractures

    Time frame: 30 and 90 days

  10. Proportion of participants who develop upper gastrointestinal bleeds/peptic or gastric ulcers

    Time frame: 30 and 90 days

  11. Time to next emergency department visit or admission for asthma

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Changi General Hospital

Other

Collaborators

  • Singapore General Hospital

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jun 14, 2022
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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