Benralizumab Initiated During Severe Asthma Attack
Status:
Recruiting
Trial end date:
2023-08-01
Target enrollment:
Participant gender:
Summary
Approximately 300 million people have asthma worldwide and 400,000 people died from asthma
globally in 2015 (GINA Asthma). Singapore's asthma mortality and hospitalisation rates are
several times higher than OECD countries. Spot Blood eosinophil count (BEC) during an acute
exacerbation of asthma was a predictor of more severe respiratory failure and was associated
with future acute health care utilization (HR 1.8, 95% CI 1.1-2.9, p=0.02) in a previous
study conducted across 4 ICUs in Singapore. Benralizumab, an anti-IL5 receptor α monoclonal
antibody causes rapid depletion of blood eosinophils and reduces asthma exacerbations when
given over 12-month duration in patient with Severe Eosinophilic Asthma. However, the
efficacy of Benralizumab when given during an acute exacerbation of asthma in reducing future
exacerbations or severity of asthma exacerbation is relatively unexplored. A Phase 2A
randomized double-blind placebo-controlled trial involving the use of one dose of the
intravenous formulation of Benralizumab (0.3 mg/kg or 1.0mg/kg) in patients presenting with
acute asthma exacerbation did not demonstrate difference in the proportion of subjects with
>/=1 asthma exacerbation at 12 weeks when compared to placebo (33.3% vs. 38.9%; P=0.67).
However, compared with placebo, Benralizumab reduced asthma exacerbation rates by 49% (3.59
vs 1.82; P=0.01) and exacerbations resulting in hospitalization by 60% (1.62 vs 0.65; P=.02)
in the combined groups at 12 weeks (secondary outcomes).
Benralizumab, an anti-IL5 receptor α monoclonal antibody causes rapid depletion of blood
eosinophils and reduces asthma exacerbations when given over 12-month duration in patient
with Severe Eosinophilic Asthma.
This study aims to look at whether subcutaneous administration of Benralizumab when initiated
during an acute severe asthma exacerbation and then continued over 48 weeks period can
increase time to first exacerbation compared to placebo as well as other key secondary
outcome such as hospital readmission and health care utilization.
We hypothesise that administration of Benralizumab when initiated during an acute severe
asthma exacerbation and then continued over 48 weeks period can increase time to first
exacerbation compared to placebo as well as other key secondary outcome such as hospital
readmission and health care utilization.