NCT04991805

Descriptive Study of the Incidence of Malignancy in Severe Asthma Patients Receiving Benralizumab and Other Biologic Therapy, a Post Authorization Safety Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 14,000 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

This is a real-world, observational, prospective cohort study in patients with severe asthma recruited into the International Severe Asthma Registry (ISAR) and the US severe asthma registry (CHRONICLE) and followed-up for occurrence of new malignancies. The primary objective is to measure the incidence of malignancy in the overall severe asthma population as well as its relevant subgroups, including patients receiving benralizumab, patients receiving non-benralizumab biologics, and patients not receiving biologics. The secondary objective is to describe the clinical characteristics of new malignancy cases that develop in severe asthma patients and relevant subgroups.

Conditions

• Asthma
• Neoplasms

Timeline

• Start date: 2021-02-26
• Primary completion: 2024-04-05
• Completion: 2024-04-05
• First posted: 2021-08-05
• Last updated: 2025-04-25

Locations

2 sites across 2 countries: Sweden, United Kingdom