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NCT04991805Completed

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

Source: ClinicalTrials.gov · Last updated 25 Apr 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
14000 (actual)
First submitted
28 Jul 2021
Start date
26 Feb 2021
Primary completion date
5 Apr 2024
Lead sponsor
AstraZeneca
Diseases
Asthma
NCT number
NCT04991805

What you commit to

  • Study type: Observational
  • Participants enrolled: 14000
  • From 26 Feb 2021 to the primary completion date, 5 Apr 2024
  • 2 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

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

Who the study is looking for

  • 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.

Age in the registry: 18 years to 130 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
-
Coordinator of this site? Confirm its status
NorwichUnited KingdomUnknown status
-
Coordinator of this site? Confirm its status
StockholmSwedenUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.