Ignite Creation Date:
2024-05-06 @ 3:23 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04617171
Status:
UNKNOWN
Last Update Posted:
2021-07-23
First Post:
2020-06-26
Brief Title:
Benralizumab Initiated During Severe Asthma Attack
Sponsor:
Singapore General Hospital
Organization:
Singapore General Hospital
Study Overview
Official Title:
Randomized Double Blind Placebo Controlled Trial of Benralizumab an Antiinterleukin 5 Receptor α Monoclonal Antibody Initiated During Hospitalization for Severe Asthma Attack in Reducing Severe Exacerbations Phase 2B Study
Status:
UNKNOWN
Status Verified Date:
2021-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Approximately 300 million people have asthma worldwide and 400000 people died from asthma globally in 2015 GINA Asthma Singapores 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 18 95 CI 11-29 p002 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 03 mgkg or 10mgkg 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 333 vs 389 P067 However compared with placebo Benralizumab reduced asthma exacerbation rates by 49 359 vs 182 P001 and exacerbations resulting in hospitalization by 60 162 vs 065 P02 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
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
Detailed Description:
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 03 mgkg or 10mgkg 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 333 vs 389 P067 However compared with placebo Benralizumab reduced asthma exacerbation rates by 49 359 vs 182 P001 and exacerbations resulting in hospitalization by 60 162 vs 065 P02 in the combined groups at 12 weeks secondary outcomes
The purpose of this study is to look at whether Benralizumab an anti-IL5 receptor α monoclonal antibody given subcutaneously compared to placebo given subcutaneously can increase time to first exacerbation reduce health care utilisation and improve other asthma outcomes in patients presenting with acute severe asthma exacerbation requiring hospitalisation Randomized double-blind placebo-controlled trial design was chosen to reduce selection bias by randomisation and concealment of allocation reduce analysis or interobserver ascertainment bias by blinding and reduce bias introduced by exclusion after randomisation by using Intention- to-treat ITT analysis In addition biomarker stratified approach using spot BEC or 300 cellsmicroL during an acute exacerbation will be used to evaluate its role as a predictive biomarker for response to Benralizumab
The study aims to recruit 128 patients over a 2-year period at Singapore General Hospital and Changi General Hospital
The purpose of this study is to look at whether Benralizumab an anti-IL5 receptor α monoclonal antibody given subcutaneously compared to placebo given subcutaneously can increase time to first exacerbation reduce health care utilisation and improve other asthma outcomes in patients presenting with acute severe asthma exacerbation requiring hospitalisation Randomized double-blind placebo-controlled trial design was chosen to reduce selection bias by randomisation and concealment of allocation reduce analysis or interobserver ascertainment bias by blinding and reduce bias introduced by exclusion after randomisation by using Intention- to-treat ITT analysis In addition biomarker stratified approach using spot BEC or 300 cellsmicroL during an acute exacerbation will be used to evaluate its role as a predictive biomarker for response to Benralizumab
The study aims to recruit 128 patients over a 2-year period at Singapore General Hospital and Changi General Hospital
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None