Eosinophilic asthma phenotypes and associated clinical outcomes

Study identification

• EU PAS number:
  EUPAS31500
• Study ID:
  31501
• Official title and acronym:
  Eosinophilic asthma phenotypes and associated clinical outcomes
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  We will conduct a historical database study to characterise risk in regard to eosinophilic and non-eosinophilic asthma phenotypes and associated characteristics.The study will include asthma patients, aged ≥13 years, who had controller or reliever inhaler therapy prescribed in the most recent 12 months of electronic medical records (EMR) extracted from UK general practices delivering data to Optimum Patient Care Research Database (OPCRD) and Clinical Practice Research Datalink (CPRD). Patients need to have at least one blood eosinophil recorded after first asthma diagnosis.To better understand the heterogeneity of asthma two different strategies will be applied to identify phenotypes. Patients will be classified into different grades of likelihood of eosinophilic asthma based on blood eosinophil counts and clinical features. In addition, unsupervised cluster analyses will be performed to identify different phenotypes of asthma which will be compared with the predefined phenotypes.Demographics, diagnosed comorbidities, clinical characteristics, such as asthma severity and control and health care resource utilisation (HCRU) will be described and compared for different phenotypes (both predefined and identified clusters) over the last 12 months of EMR data.Among patients who had multiple blood eosinophil counts available, those with persistently high blood eosinophil counts will be compared with patients without or with intermittently high counts using a separate design. These groups will be characterized and compared in a baseline period and clinical outcomes & HCRU will be compared in a follow-up year, using the most recent eosinophil count as the index date.
• Study status:
  Planned

Research institutions and networks

Institutions

Observational & Pragmatic Research Institute Pte (OPRI)

United Kingdom

Study timelines

Date when funding contract was signed

Planned:03/06/2019

Actual:27/06/2019

Study start date

Planned:15/10/2019

Data analysis start date

Planned:01/11/2019

Date of interim report, if expected

Planned:13/12/2019

Date of final study report

Planned:01/04/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca

Regulatory

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