FAST Study: Safety and Efficacy of Benralizumab for Severe Eosinophilic Asthma in India

A clinical trial dataset from the phase IV Fasenra Safety Trial in India (FAST) assessing benralizumab over 24 weeks. The study included 138 adult Indian patients with severe eosinophilic asthma, tracking adverse events and asthma control metrics. The data was published by Deepak Talwar on figshare in April 2026 under a CC-BY-4.0 license.

Use Cases

• Analyze treatment-emergent adverse event rates based on reported incidences of pyrexia, dyspnea, and cough.
• Model time-to-first asthma exacerbation based on the reported median of 100 days.
• Assess changes in asthma control status based on the reported proportions of well-controlled and partly controlled patients.
• Evaluate the reduction in annualized asthma exacerbation rates based on the reported decrease from a median of 2.0 to 0 events per year.

Strengths

• Includes safety and efficacy outcomes for 138 patients over a 24-week period.
• Reports specific baseline metrics, including a median absolute eosinophil count of 375.0 cells/mm³.
• Provides detailed adverse event breakdowns, including the incidence of serious TEAEs (3.6%).

Limitations

• Column-level documentation is absent; field semantics must be inferred after download.
• Row count is unknown, which may limit suitability assessment.
• Data is from a single-arm, non-randomized study design, which limits comparative analysis.

Provenance

Source

Phase IV clinical trial (NCT05384938) conducted at multiple centers in India.

Collection Method

Prospective, single-arm, interventional study with patients receiving subcutaneous benralizumab.

Time Range

The study period covered 24 weeks of treatment and observation.

Freshness

Last updated 2026-04-20 10:05:34; freshness should be verified.

Geography

India