PredictIng the risk for first COPD severe exacerbation (PRECISE-X)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/108395
• EU PAS number:
  EUPAS50803
• Study ID:
  108395
• Official title and acronym:
  PredictIng the risk for first COPD severe exacerbation (PRECISE-X)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This study aims to examine whether existing COPD risk prediction models are capable of predicting the first severe exacerbations, and if not, develop a risk model for predicting first-time occurrence of severe COPD exacerbation. The model will use common recorded variables as predicting indicators with the main intent to help clinicians to define the individual risk of a severe exacerbation at the time of diagnosis, similar to the cardiovascular risk scores (SCORE, Framlingham).
• Study status:
  Ongoing

Research institutions and networks

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: 19/01/2023

Actual: 19/01/2023

Study start date

Planned: 28/02/2023

Actual: 22/04/2024

Data analysis start date

Planned: 01/05/2024

Date of interim report, if expected

Planned: 31/08/2024

Date of final study report

Planned: 30/09/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca UK Limited

Regulatory

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