Study identification

PURI

https://redirect.ema.europa.eu/resource/27888

EU PAS number

EUPAS25489

Study ID

27888

Official title and acronym

Demographic and Clinical Characteristics of Severe Asthma Patients Worldwide

DARWIN EU® study

No

Study countries

Australia
Italy
Korea, Republic of
United Kingdom
United States

Study description

This study aims to inform the asthma scientific community of the demographic and clinical characteristics of severe asthma patients seen at severe asthma centres across the globe. This will help drive the next key research questions to be asked at the country, region, and international level.This is a cross-sectional study to describe the severe asthma population, utilising data from the International Severe Asthma Registry (ISAR) to descriptively illustrate differences and similarities of demographic and clinical attributes of severe asthma patients globally. The study will include adult severe asthma patients receiving treatment according to the Global Initiative of Asthma (GINA) Step 5 or uncontrolled on GINA Step 4. Descriptive statistics will be summarized for demographic factors and clinical characteristics, including medical history, healthcare resource utilisation, blood test measurements, fractional exhaled nitric oxide (FeNO) test, comorbidities and medication use categories.

Study status

Finalised
Research institution and networks

Institutions

Networks

Respiratory Effectiveness Group (REG)
Belgium
Denmark
France
Germany
Greece
Hungary
Italy
Netherlands
Spain
Sweden
United Kingdom
First published:
08/07/2021
Network
ENCePP partner

Contact details

David Price

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Date of interim report, if expected

Planned:

Date of final study report

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

More details on funding

AstraZeneca, OPC Global
Study protocol
Initial protocol
English (350.75 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable