Study identification

PURI

https://redirect.ema.europa.eu/resource/32956

EU PAS number

EUPAS31355

Study ID

32956

Official title and acronym

The Characterization and Comparison of Eosinophilic and Non-eosinophilic Phenotypes of Severe Asthma

DARWIN EU® study

No

Study countries

Bulgaria
Canada
Greece
Ireland
Italy
Japan
Korea, Republic of
Kuwait
Spain
United Kingdom
United States

Study description

This cross-sectional study design is the first step to better understand and assess the presence of eosinophilic and non-eosinophilic asthma phenotypes using known constructs of severe asthma epidemiology. Firstly, most likely non-eosinophilic asthma patients will be identified followed by discerning eosinophilic asthma patients with most likely versus likely degrees of confidence. The characteristics of eosinophilic and non-eosinophilic phenotypes will be compared to a benchmark (published results from a similar study population). Data for this study will be sourced from the International Severe Asthma Registry (ISAR). Parallel analyses using a primary care observational database, the Optimum Patient Care Research Database (OPCRD), will be conducted for providing a benchmark for comparison.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Respiratory Effectiveness Group (REG)
Belgium
Denmark
France
Germany
Greece
Hungary
Italy
Netherlands
Spain
Sweden
United Kingdom
First published:
04/06/2024
Network
ENCePP partner

Contact details

David Price

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Other
Pharmaceutical company and other private sector 

More details on funding

AstraZeneca, OPCG
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable