A prediction model for future exacerbation risk in children

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/31045
• EU PAS number:
  EUPAS17985
• Study ID:
  31045
• Official title and acronym:
  A prediction model for future exacerbation risk in children
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Asthma attacks in children are common and result in considerable morbidity and occasionally mortality. Additionally, childhood asthma attacks may adversely affect their education, their parents economic productivity and always incur costs to the healthcare system. Remarkably little is understood about factors which predict childhood asthma attacks and much of what is known is derived from relatively small clinical trials in countries other than the UK and the results may not be generalisable. The present analysis will use routinely acquired data collected in primary care in the UK to identify factors associated with asthma attacks in children. Predictive variables will include demographics (the child’s age and sex), asthma characteristics (severity, control and past attacks) and physiological measurements (obesity, lung function and blood eosinophil count). Blood and airway eosinophilia are both risk factors for asthma attacks in adults and whilst the latter would be preferable, this is not routinely collected whereas blood eosinophil count is often measured and is used in this analysis.
• Study status:
  Finalised

Research institution and networks

Institutions

Respiratory Effectiveness Group

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: 03/02/2017

Actual: 03/02/2014

Study start date

Planned: 24/02/2017

Actual: 24/02/2014

Date of final study report

Planned: 28/04/2017

Actual: 23/09/2014

Sources of funding

Other

More details on funding

Respiratory Effectiveness Group

Study protocol

Initial protocol

REG Study Protocol_Future Risk of Asthma Exacerbations_FINAL

Regulatory

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