Study identification

PURI

https://redirect.ema.europa.eu/resource/106968

EU PAS number

EUPAS106967

Study ID

106968

Official title and acronym

Patient characteristics, treatment patterns, clinical outcomes, and health care resource utilization in severe asthma subgroups: A retrospective analysis of the International Severe Asthma Registry (EVEREST)

DARWIN EU® study

No

Study countries

Argentina
Australia
Bulgaria
Canada
Colombia
Denmark
Greece
India
Italy
Japan
Korea, Republic of
Kuwait
Mexico
Poland
Portugal
Saudi Arabia
Spain
Taiwan
United Arab Emirates
United Kingdom
United States

Study description

Asthma is a heterogeneous disease with a complex pathophysiology that presents with a wide range of clinical manifestations and treatment responses. Recent advances in treatment strategies for severe asthma include the development and release of targeted biologics for treatment. Eligibility for biologic treatment is based on clinical and pathobiological markers, including biomarkers such as immunoglobulin E (IgE), fractional exhaled nitric oxide (FeNO), and blood eosinophil count (BEC). Despite these advances in treatment, the clinical burden for severe asthma remains high. The primary goal of this analysis is to use data from the International Severe Asthma Registry (ISAR) registry to describe characteristics and unmet needs for patients with subtypes of severe asthma, including patients who are ineligible for current biologic treatment (biologic-ineligible), patients who are biologic-eligible, patients who are biologic-eligible with and without biologic treatment, patients on biologic therapy with uncontrolled asthma, patients with multiple positive asthma-specific biomarkers, patients with low vs high blood eosinophils count (BEC), and patients with allergic asthma. As an exploratory objective, this study will also examine the variability of asthma-specific biomarkers over time.

Study status

Finalised
Research institutions and networks

Institutions

Networks

Contact details

David Price

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
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