Status: Finalised First registered on: 23/04/2018
Last updated on: 07/06/2022
1. Study identification
EU PAS Register NumberEUPAS23651
Official titleInternational Severe Asthma Registry
Study title acronymISAR
Study typeObservational study
Brief description of the studyThe international Severe Asthma Registry (ISAR) is a multi-country, multicentre, observational initiative to gather anonymous longitudinal real-life data, for patients with severe asthma from over 14 countries. The purpose of the registry is to provide a mechanism to store data to enable greater power to answer key research questions in severe asthma across the collaborating countries. The key feature of the International Severe Asthma Registry will be a standardised annualised recording of: • A key set of severe asthma related data points • Selected enhanced data points for optional additional data collection • Standardised coding for data point variables and • Standardised response options Due to its innovative approach with comprehensive data collection, the registry will have a core component where the key variables will be collected via eCRFs creating a large web-based registry platform in which more specific studies addressing particular objectives can be accommodated. The details of the sub-studies will be finalised and shared. The sub-studies will be conducted in subsamples of patients from the registry and the countries may choose whether or not to participate in new sub-studies without jeopardizing their status as ISAR participants. Significant changes in the protocol and new sub-studies will be reviewed by those entities prior to initiation. All patients enrolled in the ISAR platform will be followed-up annually during routine clinical visits for a total duration of up to four years.
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 (OPC)
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

Australia
Bulgaria
Canada
Denmark
Estonia
Finland
France
Germany
Greece
Iceland
Italy
Japan
Korea, Republic of
Netherlands
Norway
Spain
Sweden
United Kingdom
United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/05/201715/05/2017
Start date of data collection01/11/201716/04/2018
Start date of data analysis
Date of interim report, if expected
Date of final study report01/05/202214/08/2020
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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