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

AstraZeneca

Status: Completed

Conditions: Asthma; Neoplasms

Study type: Observational

Funder types: Industry

Identifiers

NCT04991805

D3250R00042

EUPAS26310 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 14,000 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The study population includes patients with severe asthma recruited into ISAR and CHRONICLE. Severe asthma patients are defined as those receiving treatment consistent with Global Initiative for Asthma (GINA) Step 5 or who are uncontrolled on GINA Step 4 treatment regimens.

Exclusion criteria

• Patients who are not willing and able to sign written informed consent

Trial design

14,000 participants in 3 patient groups

Benralizumab

Description:

Patients who have received Benralizumab.

Other biologics

Description:

Patients who have received non benralizumab biologics.

Non-biologic

Description:

Patients who have received non biologic drug.