Biomarker Relatability in the International Severe Asthma Registry (BRISAR)

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

Optimum Patient Care (OPC)

United Kingdom

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

Study timelines

Date when funding contract was signed

Planned: 01/04/2018

Actual: 30/04/2018

Study start date

Planned: 01/05/2019

Actual: 01/05/2019

Data analysis start date

Planned: 15/07/2019

Date of interim report, if expected

Planned: 01/10/2019

Date of final study report

Planned: 29/02/2020

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