Study identification

PURI

https://redirect.ema.europa.eu/resource/33344

EU PAS number

EUPAS30430

Study ID

33344

Official title and acronym

Biomarker Relatability in the International Severe Asthma Registry (BRISAR)

DARWIN EU® study

No

Study countries

Bulgaria
Canada
Greece
Ireland
Italy
Japan
Korea, Republic of
Kuwait
Spain
United Kingdom
United States

Study description

This study aims to characterise an international severe asthma population based on their pattern of biomarkers, potentially helping clinicians to classify and understand these patients.Primary objectives of this study are to assess the degree of overlap across commonly used asthma biomarkers of Type 2 inflammation (IgE, serum eosinophils and FeNO) among a diverse international cohort of severe asthma patients, and to characterise and compare severe asthma patients positive for different combinations of asthma biomarkers.This cross-sectional study will include baseline data of patients at the point of enrolment in the International Severe Asthma Registry (ISAR). This is an international registry combining retrospective and prospective data from the United States, Canada, Greece, Italy, Ireland, South Korea, Bulgaria, Kuwait, the United Kingdom and Spain with common data points of collection agreed on by 27 asthma experts worldwide. De-identified individual patient data will be classified categorically according to baseline biomarker status for analysis of characteristics, including demographics, lung function, asthma control, exacerbations, quality of life, presence of comorbidities and asthma medications.

Study status

Ongoing
Research institution and networks

Institutions

Networks

Respiratory Effectiveness Group (REG)
Belgium
Denmark
France
Germany
Greece
Hungary
Italy
Netherlands
Spain
Sweden
United Kingdom
First published:
08/07/2021
Network
ENCePP partner

Contact details

David Price

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Start date of data analysis

Planned:

Date of interim report, if expected

Planned:

Date of final study report

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

More details on funding

AstraZeneca, OPC Global
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable