Benralizumab is a humanised, afucosylated, monoclonal antibody that binds specifically to the human interlukin-5 (IL-5) receptor alpha subunit (IL-5Rα) of target cells such as eosinophils and basophils (Takatsu et al, 1994; Toba et al, 1999; Pelaia et al, 2020). Benralizumab was generally well tolerated by patients in clinical trials, with no apparent safety concerns. This study shall be conducted at 10 centers across India. The primary outcome measures will be * Percentage of AEs a, SAEs, and TEAEs * Nature, incidence, and severity of AEs including unexpected adverse drug reactions * Percentage of patients with AEs that lead to study treatment discontinuations.
Fasenra (benralizumab) has been recently approved in India with the condition to conduct a Phase 4 postmarketing study in the Indian population, as previous studies did not include patients from India. This prospective postmarketing safety study is planned to meet the regulatory mandate and assess the safety of benralizumab treatment in adult patients of severe asthma with eosinophilic phenotype over a period of 24 weeks. This interventional study will provide insights into the potential risks of eosinophil-lowering therapies when used in routine clinical care in India. The study will also evaluate the effectiveness of benralizumab in reducing asthma exacerbations. This is a prospective, single-arm, multicentre, interventional, Phase 4 study investigating the safety, tolerability, and effectiveness of Fasenra (benralizumab) in adult patients of severe asthma with eosinophilic phenotype over a period of 24 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
139
Prospective, Single-arm Study to Assess the Safety of Fasenra® (Benralizumab) in Adult Patients of Severe Asthma with Eosinophilic Phenotype in India
Research Site
Bengaluru, India
Research Site
Chennai, India
Research Site
Delhi, India
Research Site
Hyderabad, India
Research Site
Jaipur, India
Research Site
Jodhpur, India
Research Site
Lucknow, India
Research Site
Mumbai, India
Research Site
New Delhi, India
Research Site
Noida, India
...and 3 more locations
Participants With Adverse Events (AEs), Serious AEs, and Treatment-emergent AEs
The number and percentage of participants who experienced at least one adverse event (AE), serious AE, or treatment-emergent AE experienced are presented
Time frame: From study treatment to follow-up (up to 24 weeks)
Severity of AEs
Severity of adverse events (AEs) by intensity grade
Time frame: From study treatment to follow-up (up to 24 weeks)
Participants With AEs That Led to Study Treatment Discontinuations or Modifications
Participants with adverse events (AEs) that led to study treatment discontinuations or modifications
Time frame: From study treatment to follow-up (up to 24 weeks)
Time to First Asthma Exacerbation
Time to first asthma exacerbation in days in participants with asthma exacerbation
Time frame: From study treatment to follow-up (up to 24 weeks)
Exacerbation Rate: Before and After Treatment
The annual exacerbation rate for each participant was calculated by dividing the total number of exacerbations by the number of days participated in the study and multiplying by 365.
Time frame: From study treatment to follow-up (up to 24 weeks)
Annualized Exacerbation Rate: Overall
Overall annualized exacerbation rate. The annual exacerbation rate for each participant was calculated by dividing the total number of exacerbations by the number of days participated in the study and multiplying by 365.
Time frame: From study treatment to follow-up (up to 24 weeks)
Overall Investigators Assessment
Overall investigator's assessment on the outcome of the treatment: "well controlled", "partly controlled", and "uncontrolled."
Time frame: From study treatment to follow-up (up to 24 weeks)
Change in Blood Eosinophil Levels From Baseline at Weeks 4, 16, and 24
Mean change in blood eosinophil levels from baseline at Weeks 4, 16, and 24
Time frame: Baseline and Weeks 4, 16, and 24
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