International Severe Asthma Registry (ISAR)

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:
  Argentina

  Australia

  Belgium

  Brazil

  Bulgaria

  Canada

  Colombia

  Denmark

  Ecuador

  Estonia

  France

  Greece

  India

  Ireland

  Italy

  Japan

  Korea, Republic of

  Kuwait

  Mexico

  Norway

  Poland

  Portugal

  Saudi Arabia

  Singapore

  Spain

  Taiwan

  United Arab Emirates

  United Kingdom

  United States
• Study description:
  The international Severe Asthma Registry (ISAR) is a multi-country, multicenter, observational initiative to gather de-identified longitudinal real-life data, for patients with severe asthma from over 29 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 seven years.
• Study status:
  Finalised

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: 01/05/2017

Actual: 15/05/2017

Study start date

Planned: 01/11/2017

Actual: 16/04/2018

Date of final study report

Actual: 14/08/2020

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

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable