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
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Norwich | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.