Status: Finalised
First registered on:
27/02/2015
Last updated on:
26/08/2015
1. Study identification
EU PAS Register NumberEUPAS8740
Official titleState of the Union: Current asthma morbidity in the UK
Study title acronym
Study typeObservational study
Brief description of the studyAsthma is a chronic condition with significant health and economic consequences, which may be attributable to poor control. This study characterises patients with asthma from 153 UK primary care practices and evaluates their disease severity, control and treatment.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
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 to which the investigator belongsRIRL
Department/Research group
Organisation/affiliationResearch in Real Life Ltd.
Details of (Primary) lead investigator
Title Dr
Last name Jain
First name Arjun
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
National study
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/04/201401/04/2014
Start date of data collection15/04/201415/04/2014
Start date of data analysis
Date of interim report, if expected
Date of final study report12/08/201531/07/2015
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesTeva50
Charities
Government body
Research councils
EU funding scheme
OtherREG50
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Price
First name David
Address line 116 Raffles Quay
Address line 2#33-03
Address line 3Hong Leong Building
CitySingapore
Postcode048581
CountrySingapore
Phone number (incl. country code)44-1223-967829
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Professor
Last name Price
First name David
Address line 116 Raffles Quay
Address line 2#33-03
Address line 3Hong Leong Building
CitySingapore
Postcode048581
CountrySingapore
Phone number (incl. country code)44-1223-967829
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
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 subjects30000
Additional information
Patients included in the analysis will have clinician-diagnosed asthma (i.e. a diagnostic Read code for asthma compatible with UK Quality and Outcomes Framework) and will be receiving current asthma therapy (≥1 asthma prescription in the last 2 years).
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources not registered with ENCePP
Optimum Patient Care Research Database, United Kingdom
Sources of data
Routine primary care electronic patient registry
11. Scope of the study
What is the scope of the study?
Disease epidemiology
Primary scope : Disease epidemiology
12. Main objective(s)
What is the main objective of the study?
This study will characterise patients with asthma from UK primary care practices and evaluates their disease severity, control and treatment.
Are there primary outcomes?No
Are there secondary outcomes?No
13. Study design
What is the design of the study?
Cross-sectional 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
Pooled practice and patient data will be used to characterise patients in terms of control status (classified by the Global INitiative for Asthma [GINA] and Royal College of Physician three questions); risk status (according to severe exacerbation frequency, defined as the number of asthma related hospitalisations and courses of acute oral steroids in previous 12 months); treatment step (as classified by GINA); and smoking status (current, ex-smoker or non-smoker). Summary statistics will be produced for all variables: for those measured on the interval/ratio scale, n and % of non-missing data, mean (standard deviation) or median (inter-quartile range); for categorical variables, n (%) of non-missing data and n (%) per category.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
Not submitted
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
