1. Study identification
EU PAS Register NumberEUPAS5171
Official titleCharacteristics of asthma patients at risk of failed Diskus use in primary care: a retrospective cohort study
Study title acronym
Study typeObservational study
Brief description of the studyRetrospective, cross-sectional, observational, database analysis using the
international dataset: implementing Helping Asthma in Real Patients (iHARP) for describing characteristics of patients at risk of making critical errors in usage of DPI Diskus for there asthma.
Was this study requested by a regulator?Don't know
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
International study
Australia
France
Italy
Netherlands
Norway
Spain
Sweden
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/11/201301/11/2013
Start date of data collection03/01/201103/01/2011
Start date of data analysis07/10/2013
Date of interim report, if expected
Date of final study report07/01/201415/03/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesTEVA100
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 1East View 5 Coles Lane
Address line 2
Address line 3
CityCambridge
PostcodeCB24 3BA
CountryUnited Kingdom
Phone number (incl. country code)01223967582
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Miss
Last name Carter
First name Victoria
Address line 1East View 5 Coles Lane
Address line 2
Address line 3
CityCambridge
Postcode
CountryUnited Kingdom
Phone number (incl. country code)441223967855
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)No
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 subjects500
10. Source of data
Is this study being carried out with an established data source?No
Sources of data
Spontaneous reporting
11. Scope of the study
What is the scope of the study?
Disease epidemiology
Risk assessment
Primary scope : Disease epidemiology
12. Main objective(s)
What is the main objective of the study?
Describe characteristics of patients at risk of failed diskus use
Are there primary outcomes?Yes
Characteristics
Are there secondary outcomes?Yes
Risk assessment
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
We evaluated patient subjective and objective usage of inhaler, patient demographic characteristics, smoking state and comorbidity and asthma outcome were obtain from the iHARP database.
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
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