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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-26

Study Completion Date

2024-04-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Asthma Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Benralizumab

Patients who have received Benralizumab.

No interventions assigned to this group

Other biologics

Patients who have received non benralizumab biologics.

No interventions assigned to this group

Non-biologic

Patients who have received non biologic drug.

No interventions assigned to this group

Eligibility Criteria

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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.