Status: Finalised First registered on: 18/11/2020
Last updated on: 04/02/2022
1. Study identification
EU PAS Register NumberEUPAS38128
Official titleEffectiveness across severe asthma biologic classes (Anti-IL-5 vs Anti IgE) in patients eligible for both
Study title acronymFIRE
Study typeObservational study
Brief description of the studyThis 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).
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 (OPCG)
Centre locationUK
Details of (Primary) lead investigator
Title Professor
Last name David
First name Price
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
Greece
India
Ireland
Italy
Japan
Korea, Democratic People's Republic of
Kuwait
Mexico
Saudi Arabia
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 signed15/01/201915/03/2019
Start date of data collection01/11/201911/11/2019
Start date of data analysis01/08/202001/09/2020
Date of interim report, if expected
Date of final study report31/12/202119/01/2022
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 David
First name Price
Address line 15 Coles Lane
Address line 2 
Address line 3 
CityOakington, Cambridge 
PostcodeCB24 3BA 
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 David 
First name Price 
Address line 15 Coles Lane 
Address line 2 
Address line 3 
CityOakington, Cambridge 
PostcodeCB24 3BA 
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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