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NCT04991805 Clinical Trial

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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04991805
Other study ID # D3250R00042
Secondary ID EUPAS26310
Status Completed
Phase
First received
Last updated
Start date February 26, 2021
Est. completion date April 5, 2024

Study information
Verified date May 2024
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 14000
Est. completion date April 5, 2024
Est. primary completion date April 5, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 130 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Sweden Research Site Stockholm
United Kingdom Research Site Norwich Norfolk

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

Sweden,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Neoplasm Incidence of neoplasm each year, starting from index date. Annually, up to 5 years
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