Development, validation, utility and economic assessment of a flexible, individualized risk prediction e-tool for exacerbation in patients with severe asthma (Severe asthma risk prediction)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/46089
• EU PAS number:
  EUPAS46088
• Study ID:
  46089
• Official title and acronym:
  Development, validation, utility and economic assessment of a flexible, individualized risk prediction e-tool for exacerbation in patients with severe asthma (Severe asthma risk prediction)
• DARWIN EU® study:
  No
• Study countries:
  Singapore
• Study description:
  Individualized prediction of rate of severe exacerbation in patients with severe asthma may improve efficiency of specialist asthma care and the value proposition of advanced treatment options such as therapeutic biologics in asthma. This study aims to develop and validate an individualized risk prediction tool, and implement it via e-health applications (i.e., interactive web and smart phone apps), to inform personalized risk and rate of severe asthma exacerbation at a flexible timepoint. We will further perform decision curve analysis to identify the test-treatment strategies that optimize the clinical utility of this prediction tool, considering prediction accuracy and clinician’s risk preference, and identify the cost-effective risk-adaptive intervention strategies that tailor follow-up frequency, specialist care and advanced biologic treatment to an individual asthma patient. To address these study aims, we will retrieve data from three large international clinical trials to develop the model, and use data from the International Severe Asthma Registry and Singapore asthma cohort to externally validate the model and assess its clinical utility. We are optimistic about the long-term demand for the outputs of this research, its potential for sustainability and growth, and its ability to improve patient care and outcomes, and advance Precision Medicine and Digital Health research in respiratory research.
• Study status:
  Planned

Research institutions and networks

Institutions

National University of Singapore

Study timelines

Date when funding contract was signed

Actual: 05/01/2022

Study start date

Planned: 31/03/2022

Data analysis start date

Planned: 15/04/2022

Date of final study report

Planned: 31/03/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Singapore Ministry of Education Tier 1 Grant, Optimum Patient Care Global (OPCG)

Regulatory

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