Status: Ongoing First registered on: 24/07/2019
Last updated on: 31/01/2020
1. Study identification
EU PAS Register NumberEUPAS30430
Official titleBiomarker Relatability in the International Severe Asthma Registry
Study title acronymBRISAR
Study typeObservational study
Brief description of the studyThis 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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameOptimum Patient Care Global Limited (OPCG)
Centre locationUK
Details of (Primary) lead investigator
Title Professor
Last name Price
First name David
Is this study being carried out with the collaboration of a research network?
Yes

Optimum Patient Care (OPC)
Respiratory Effectiveness Group (REG)
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
International study

Bulgaria
Canada
Greece
Ireland
Italy
Japan
Korea, Republic of
Kuwait
Spain
United Kingdom
United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/04/201830/04/2018
Start date of data collection01/05/201901/05/2019
Start date of data analysis15/07/2019
Date of interim report, if expected01/10/2019
Date of final study report29/02/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAstraZeneca50
Charities
Government body
Research councils
EU funding scheme
OtherOPC Global50
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Price
First name David
Address line 15 Coles Lane
Address line 2 
Address line 3 
CityOakington, Cambridge 
PostcodeCB24 3BA 
CountryUnited Kingdom
Phone number (incl. country code)44-7787-905057 
Alternative phone number 
Fax number (incl. country code) 
Email address dprice@opri.sg
Public Enquiries
Title Professor 
Last name Price 
First name David 
Address line 15 Coles Lane 
Address line 2 
Address line 3 
CityOakington, Cambridge 
PostcodeCB24 3BA 
CountryUnited Kingdom 
Phone number (incl. country code)44-7787-905057 
Alternative phone number 
Fax number (incl. country code) 
Email address dprice@opri.sg 
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