Development and validation of a risk prediction tool for oral corticosteroid adverse outcomes in asthma, based on real-world exposure information

Study identification

• EU PAS number:
  EUPAS1000000336
• Study ID:
  1000000336
• Official title and acronym:
  Development and validation of a risk prediction tool for oral corticosteroid adverse outcomes in asthma, based on real-world exposure information
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This study used Optimum Patient Care Research patient records (Jan 1990 to Jun 2021) to develop models for predicting the risk that adults with active asthma at an index visit would have post-index onset of 18 adverse outcomes known to be associated with exposure to oral corticosteroids (OCS), based on independent risk factors known to be associated with these outcomes and projected longitudinal changes in OCS exposure (ie, decreased, unchanged, or increased).
• Study status:
  Planned

Research institutions and networks

Institutions

Observational & Pragmatic Research Institute Pte (OPRI)

United Kingdom

Networks

Optimum Patient Care (OPC) Network

United Kingdom (Northern Ireland)

Study timelines

Date when funding contract was signed

Planned:30/03/2020

Actual:30/03/2020

Study start date

Planned:30/03/2020

Date of final study report

Planned:31/12/2025

Sources of funding

Non-for-profit organisation (e.g. charity)

Pharmaceutical company and other private sector 

More details on funding

Research part funded by AstraZeneca and the Observational and Pragmatic Research Institute.

Regulatory

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