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

  • End date
    Dec 31, 2023
  • participants needed
  • sponsor
Updated on 22 October 2022
primary cancer


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

Condition Asthma, Neoplasms
Clinical Study IdentifierNCT04991805
Last Modified on22 October 2022


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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