Using real-life patient records to help identify predictors of future exacerbation risk (Asthma risk predictors)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/26292
• EU PAS number:
  EUPAS4869
• Study ID:
  26292
• Official title and acronym:
  Using real-life patient records to help identify predictors of future exacerbation risk (Asthma risk predictors)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Background: Increased understanding of exacerbation patterns and the individual and clusters of risk factors associated with them could help to define ‘frequent exacerbators’ more meaningfully (e.g. as a persistent group of patients at the high end of the control continuum, or a dynamic group population made up of patients experiencing disease phases during which their exacerbation risk is elevated due to specific triggers). Improved understanding of the relationships between patient characteristics and frequent exacerbation risk will help to inform the development of new assessment tools, treatment strategies and interventions aimed at reducing the significant morbidity (and cost) associated with asthma exacerbations.This study aims to identify patient characteristics recorded within routine primarycare datasets that are associated with increased risk of frequent asthmaexacerbations, with the ultimate goal of:1. Characterising the frequent exacerbator subgroup of asthma patients2. Identifying individual risk factors associated with increased futureexacerbation risk3. Exploring clusters of risk factors associated with increased risk of futureexacerbation risk.
• Study status:
  Finalised

Research institution and networks

Institutions

Research in Real Life

Networks

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: 08/10/2013

Actual: 02/12/2013

Study start date

Planned: 06/01/2014

Actual: 06/01/2014

Date of final study report

Planned: 30/04/2014

Actual: 31/12/2014

Sources of funding

Other

More details on funding

Respiratory Effectiveness Group (REG), Research in Real Life Ltd

Study protocol

Initial protocol

Asthma risk characterisation_REG study proposal_12Nov13

Regulatory

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