At a glance
ClinicalIndex Comparison Record- ✓Age 18-75 years at informed consent
- ✓Physician-confirmed severe asthma for ≥12 months with eosinophil count ≥300 cells/μL at screening
- ✓On high-dose ICS (>500 μg fluticasone propionate equivalent or >800 μg budesonide equivalent) plus LABA for ≥3 months prior to enrollment
- ✓Pre-bronchodilator FEV1 <80% predicted at screening by spirometry
- ✕Other clinically important pulmonary disease (active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis)
- ✕History of pulmonary/systemic disease associated with elevated eosinophils (ABPA/mycosis, Churg-Strauss, hypereosinophilic syndrome)
- ✕Currently enrolled in parallel interventional clinical study or receiving any biologic
- ✕Prior biologic use within 30 days before informed consent
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Postmarketing, Phase 4, Multicentre, Prospective, Single-arm Study to Assess the Safety of Fasenra® (Benralizumab) in Adult Patients of Severe Asthma With Eosinophilic Phenotype in India.
In Brief
A Phase 4 clinical trial evaluating Benralizumab for In Adult Patients of Severe Asthma With Eosinophilic Phenotype in India. Completed, enrolled 139 participants across 13 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
Prospective, Single-arm Study to Assess the Safety of Fasenra® (Benralizumab) in Adult Patients of Severe Asthma with Eosinophilic Phenotype in India