Study identification

PURI

https://redirect.ema.europa.eu/resource/43405

EU PAS number

EUPAS40583

Study ID

43405

Official title and acronym

Onset of asthma in severe asthma patients (PATH)

DARWIN EU® study

No

Study countries

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

Study description

This study aim is to describe and compare the demographic and clinical features of early-onset vs late-onset asthma phenotypes in an international cohort of adult patients with severe asthma. The primary objectives are: ● To describe the distribution of age of asthma onset in the international severe asthma registry cohort ● To define and validate the most appropriate age cut-off to delineate age-of-onset groups ● To describe and compare the demographic and clinical characteristics of the early-onset vs late-onset asthma phenotypes in adult patients with severe asthma The secondary objective is to evaluate possible geographical differences in early-onset and late-onset asthma phenotypes in severe asthma population. Data will be sourced from the International Severe Asthma Registry (ISAR). Anonymized person-level data from 9 countries will be used for this analysis. ISAR has governance provided by the ISAR scientific steering committee, The Anonymous Data Ethics Protocols and Transparency (ADEPT) committee, an independent body of experts and regulators commissioned by the Respiratory Effectiveness Group (REG).

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, OPC Global
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable