Study identification

EU PAS number

EUPAS38288

Study ID

48128

Official title and acronym

Defining and Characterizing Responders to Biologic Treatment (BEAM)

DARWIN EU® study

No

Study countries

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

Study description

This is a registry cohort study in which we will operationally define responders to biologic treatment by clinical endpoints and describe their characteristics overall and per biologic class (anti-IgE and anti-IL5). Initially, response to a biologic therapy will be evaluated based on improvements of single domains including exacerbation rate, cumulative OCS dose, long-term OCS dose, asthma control and lung function from pre- to post-therapy. To avoid duplication of information, response will be examined for the first biologic only. The level of responsiveness will then be assessed based on the overlap of the following four domains: exacerbation rate, long-term OCS use, asthma control and lung function. Data will be sourced from the International Severe Asthma Registry (ISAR).

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:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

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