Study identification

EU PAS number

EUPAS38128

Study ID

45615

Official title and acronym

Effectiveness across severe asthma biologic classes (Anti-IL-5 vs Anti IgE) in patients eligible for both (FIRE)

DARWIN EU® study

No

Study countries

Argentina
Bulgaria
Canada
Colombia
Denmark
Greece
India
Ireland
Italy
Japan
Korea, Democratic People's Republic of
Kuwait
Mexico
Saudi Arabia
Spain
Taiwan
United Arab Emirates
United Kingdom
United States

Study description

This is a prospective cohort study in which we will use a propensity score weighting approach to examine the effectiveness of initiating Anti-IgE versus Anti-IL5 among patients who are eligible for both modalities. In Phase 1, the demographic and clinical characteristics among all participants who are eligible for both modalities will be studied. These include patients who have an elevated blood eosinophil count, total serum IgE level, 2 or more pre-therapy exacerbation and allergic mediated asthma. In Phase 2, the two study arms will be balanced using propensity score weighting. After this, using weighted longitudinal regression analysis, the two groups will be compared to describe the health outcomes between the groups. These include the rate of exacerbations, OCS use and healthcare resource utilization. Data will be sourced from the International Severe Asthma Registry (ISAR).

Study status

Finalised
Research institutions and networks

Institutions

Networks

Contact details

Price David

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:
Actual:
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