Status: Finalised First registered on: 26/11/2020
Last updated on: 12/07/2022
1. Study identification
EU PAS Register NumberEUPAS38288
Official titleDefining and Characterizing Responders to Biologic Treatment
Study title acronymBEAM
Study typeObservational study
Brief description of the studyThis 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).
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameOptimum Patient Care Global Limited (OPCG)
Centre locationUK
Details of (Primary) lead investigator
Title Professor
Last name Price
First name David
Is this study being carried out with the collaboration of a research network?
Yes

Respiratory Effectiveness Group (REG)
Optimum Patient Care (OPC)
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
International study

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
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/03/202001/03/2020
Start date of data collection01/12/201501/12/2015
Start date of data analysis01/08/202001/08/2020
Date of interim report, if expected01/11/202001/11/2020
Date of final study report31/05/202217/06/2022
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAstraZeneca50
Charities
Government body
Research councils
EU funding scheme
OtherOPC Global50
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Price
First name David
Address line 15 Coles Lane
Address line 2 
Address line 3 
CityOakington, Cambridge 
Postcode 
CountryUnited Kingdom
Phone number (incl. country code)44-7787-905057 
Alternative phone number 
Fax number (incl. country code) 
Email address dprice@opri.sg
Public Enquiries
Title Professor 
Last name Price 
First name David 
Address line 15 Coles Lane 
Address line 2 
Address line 3 
CityOakington, Cambridge 
Postcode 
CountryUnited Kingdom 
Phone number (incl. country code)44-7787-905057 
Alternative phone number 
Fax number (incl. country code) 
Email address dprice@opri.sg 
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