Status: Ongoing
First registered on:
13/08/2019
Last updated on:
07/10/2019
1. Study identification
EU PAS Register NumberEUPAS30943
Official titleLongitudinal systemic corticosteroid utilization in the UK, 1990-2018
Study title acronym
Study typeObservational study
Brief description of the studyhe study is a historical longitudinal descriptive cohort study, describing the systemic corticosteroid use in patients with a condition (28 initially selected) for which SCS are used between 1990 and 2018. For each of the selected conditions, for each calendar year the number of patients with active condition will be collected, and for these the number of prescriptions for systemic corticosteroids and the total dose taken will be collected.
With these data changes in SCS utilisation after the introduction of new SCS-sparing therapies and/or relevant guideline changes will be described.
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
Department/Research groupObservational and Pragmatic Research Institute Pte Ltd
Organisation/affiliationOPRI Pte Ltd
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?
No
Other centres where this study is being conducted
Not applicable (single centre)
Countries in which this study is being conducted
National study
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed03/06/2019
Start date of data collection02/09/201902/09/2019
Start date of data analysis03/09/201903/09/2019
Date of interim report, if expected15/12/2019
Date of final study report01/02/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAstraZeneca100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Price
First name David
Address line 15a Coles Lane
Address line 2Oakington
Address line 3
CityCambridge
Postcode
CountryUnited Kingdom
Phone number (incl. country code)441223967582
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Professor
Last name Price
First name David
Address line 15a Coles Lane
Address line 2Oakington
Address line 3
CityCambridge
Postcode
CountryUnited Kingdom
Phone number (incl. country code)441223967582
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Substance class (ATC Code)H02 (CORTICOSTEROIDS FOR SYSTEMIC USE, COMBINATIONS)
7. Medical conditions to be studied
Medical condition(s)No
8. Population under study
Age
Children (2 - 11 years)
Adolescents (12 - 17 years)
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 subjects6000000
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
Sources of data
Routine primary care electronic patient registry
11. Scope of the study
What is the scope of the study?
Drug utilisation study
Primary scope : Drug utilisation study
12. Main objective(s)
What is the main objective of the study?
To describe systemic corticosteroid use over time in up to 28 conditions, including asthma and COPD. To describe changes around the introduction of SCS-sparing therapies (e.g. biologics) and/or relevant treatment guideline changes.
Are there primary outcomes?No
Are there secondary outcomes?No
13. Study design
What is the design of the study?
Cohort study
Drug utilisation study
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
Until the end of data avilability.
15. Data analysis plan
Please provide a brief summary of the analysis method
The study is a historical longitudinal descriptive cohort study, describing the systemic corticosteroid use in patients with a condition (28 initially selected) for which SCS are used between 1990 and 2018. For each of the selected conditions, for each calendar year the number of patients with active condition will be collected, and for these the number of prescriptions for systemic corticosteroids and the total dose taken will be collected.
With these data changes in SCS utilisation after the introduction of new SCS-sparing therapies and/or relevant guideline changes will be described.
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
