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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50719
• 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:
  Bulgaria

  Denmark

  Finland

  Greece

  Iceland

  Ireland

  Italy

  Japan

  Korea, Republic of

  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:
  Ongoing

Research institution and networks

Institutions

AstraZeneca

Optimum Patient Care (OPC)

United Kingdom

Parexel International

Sweden

ISAR Registry: Optimum Patient Care Global Limited (OPC) UK

Networks

Optimum Patient Care (OPC) Network

United Kingdom (Northern Ireland)

Respiratory Effectiveness Group (REG)

Belgium

Denmark

France

Germany

Greece

Hungary

Italy

Netherlands

Spain

Sweden

United Kingdom

PAREXEL

Study timelines

Date when funding contract was signed

Planned: 21/03/2017

Actual: 21/03/2017

Study start date

Planned: 01/01/2018

Actual: 01/01/2018

Data analysis start date

Planned: 01/04/2021

Actual: 26/02/2021

Date of interim report, if expected

Planned: 31/12/2023

Actual: 29/11/2023

Date of final study report

Planned: 31/12/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca

Study protocol

Initial protocol

D3250R00042-pass-csp-v4_Redacted

Updated protocol

D3250R00042 - Protocol v.5_Redacted

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)

Other study registration identification numbers and links

D3250R00042