Status: Planned
First registered on:
02/02/2015
Last updated on:
24/01/2019
1. Study identification
EU PAS Register NumberEUPAS8507
Official titleThe burden of rhinitis in Australia
Study title acronym
Study typeObservational study
Brief description of the studyA set of three studies that aim to evaluate the burden of rhinitis on healthcare in Australia by assessing the real life treatment of rhinitis using prescribing and over the counter information, and the effect of introducing Dymista to the Australian market
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
National study
Australia
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed30/01/2015
Start date of data collection06/02/2015
Start date of data analysis14/02/201518/03/2015
Date of interim report, if expected
Date of final study report31/05/2015
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesMEDA Australia100
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 1University of Aberdeen
Address line 2
Address line 3
CityAberdeen
PostcodeAB24 3FX
CountryUnited Kingdom
Phone number (incl. country code)01223967582
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Professor
Last name Price
First name David
Address line 1University of Aberdeen
Address line 2
Address line 3
CityAberdeen
PostcodeAB24 3FX
CountryUnited Kingdom
Phone number (incl. country code)01223967582
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
Rhinitis allergic
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 subjects50000
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources not registered with ENCePP
NostraData, Australia
Sources of data
Pharmacy dispensing records
11. Scope of the study
What is the scope of the study?
Real life treatment of rhinitis
Primary scope : Real life treatment of rhinitis
12. Main objective(s)
What is the main objective of the study?
To evaluate the burden of rhinitis on healthcare in Australia by assessing the real life treatment of rhinitis using prescribing and over the counter information, and the effect of introducing Dymista to the Australian market
Are there primary outcomes?Yes
1) To assess the number of therapies (single vs. multiple drugs) used to treat rhinitis in Australia
2) To describe the combination of therapies used to treat rhinitis in Australia
3) To investigate the influence of OTC medications on the count and combination of therapies used to treat rhinitis in Australia
Are there secondary outcomes?Yes
4) To investigate the seasonality of rhinitis treatment patterns
5) To estimate the cost of rhinitis treatment in Australia
6) To investigate the relationship between rhinitis treatment patterns and co-morbid asthma treatment
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
• Count of therapies will be reported as means and standard deviation [SD], and/or median and inter-quartile range (25th and 75th percentiles) along with minimum and maximum values. Moreover, count of therapies will be presented as single, multiple and total number of therapies.
• Within the multiple therapy patients group, the combination of different drug will be reported as absolute numbers as well as proportions and percentages.
• Prescribed and over-the-counter medications will be reported as absolute numbers as well as proportions and percentages.
• Time series analysis will be used to explore seasonality of rhinitis treatment patterns over the study period
• The cost of rhinitis treatment will be reported as mean and median purchase (in Austrian dollars) along with their inter-quartile range and minimum and maximum values of purchases.
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
