Study identification

PURI

https://redirect.ema.europa.eu/resource/47596

EU PAS number

EUPAS23651

Study ID

47596

Official title and acronym

International Severe Asthma Registry (ISAR)

DARWIN EU® study

No

Study countries

Australia
Bulgaria
Canada
Denmark
Estonia
Finland
France
Germany
Greece
Iceland
Italy
Japan
Korea, Republic of
Netherlands
Norway
Spain
Sweden
United Kingdom
United States

Study description

The 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.

Study status

Finalised
Research institution and networks

Institutions

Networks

Respiratory Effectiveness Group (REG)
Belgium
Denmark
France
Germany
Greece
Hungary
Italy
Netherlands
Spain
Sweden
United Kingdom
First published:
04/06/2024
Network
ENCePP partner

Contact details

David Price

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

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

More details on funding

AstraZeneca, OPC Global
Study protocol
Initial protocol

OR00617_ISAR Registry Protocol_V1.2_11 April 2018

English (479.34 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable