Study identification

EU PAS number

EUPAS26310

Study ID

50719

Official title and acronym

Descriptive Study of the Incidence of Malignancy in Patients with Severe Asthma Overall and Among Those Receiving Benralizumab and Other Therapies, a Post Authorization Safety Study

DARWIN EU® study

No

Study countries

Argentina
Bulgaria
Canada
Colombia
Denmark
Finland
Germany
Greece
Iceland
India
Ireland
Italy
Japan
Korea, Republic of
Kuwait
Mexico
Saudi Arabia
Singapore
Spain
Sweden
Taiwan
United Kingdom
United States

Study description

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.

Study status

Finalised
Research institutions and networks

Institutions

AstraZeneca
First published:
01/02/2024
Institution
Parexel International
United States
First published:
10/12/2024
InstitutionNon-Pharmaceutical companyENCePP partner
ISAR Registry: Optimum Patient Care Global Limited (OPC) UK

Networks

Respiratory Effectiveness Group (REG)
Belgium
Denmark
France
Germany
Greece
Hungary
Italy
Netherlands
Spain
Sweden
United Kingdom
First published:
04/06/2024
Network
ENCePP partner
PAREXEL

Contact details

Eileen Dareng

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

AstraZeneca
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)