Status: Planned
First registered on:
03/01/2020
Last updated on:
03/01/2020
1. Study identification
EU PAS Register NumberEUPAS32724
Official titleBiologics in severe asthma: utilization patterns, causes for discontinuation and switches
Study title acronymBiologics in severe asthma
Study typeObservational study
Brief description of the studyTo describe the use of biologics in patients with severe asthma, with respect to persistence and switch to another biologic, and how this relates to asthma outcomes.
To describe the frequency, patterns, reasons and clinical outcomes for biologic treatment discontinuation and switching in a severe asthma cohort.
To describe the demographical and clinical characteristics of severe asthma patients that discontinue or switch their biologic therapy, stratified by country.
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
Other centres where this study is being conducted
Not applicable (single centre)
Countries in which this study is being conducted
International study
Singapore
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed20/12/2018
Start date of data collection31/10/2019
Start date of data analysis01/06/2019
Date of interim report, if expected
Date of final study report01/10/2019
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAstraZeneca50
CharitiesOPCG50
Government body
Research councils
EU funding scheme
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
PostcodeCB24 3BA
CountryUnited Kingdom
Phone number (incl. country code)44-7787-905057
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Professor
Last name Price
First name David
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)
6. Study drug(s) information
Not applicable (disease/epidemiology study)
7. Medical conditions to be studied
Medical condition(s)Yes
Asthma
8. Population under study
Age
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects5000
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
Sources of data
Prospective patient-based data collection
Disease/case registry
11. Scope of the study
What is the scope of the study?
Disease epidemiology
Drug utilisation study
Primary scope : Drug utilisation study
12. Main objective(s)
What is the main objective of the study?
To describe the use of biologics in patients with severe asthma, with respect to persistence and switch to another biologic, and how this relates to asthma outcomes
Are there primary outcomes?Yes
To describe the frequency, patterns, reasons and clinical outcomes for biologic treatment discontinuation and switching in a severe asthma cohort.
Are there secondary outcomes?Yes
To describe the demographical and clinical characteristics of severe asthma patients that discontinue or switch their biologic therapy, stratified by country.
13. Study design
What is the design of the study?
Cohort study
14. Follow-up of patients
Will patients be followed up?Not applicable/no follow-up
15. Data analysis plan
Please provide a brief summary of the analysis method
Stata version 14.2 SE and 15.1 MP/6 (College Station, TX, USA) will be used to conduct all
statistical analyses and data manipulations. All descriptive statistics will be done with data
that is not missing. For each variable with missing values, the percentage of missingness will be reported.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
Available when the study ends
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
