Status: Planned
First registered on:
06/07/2015
Last updated on:
06/07/2015
1. Study identification
EU PAS Register NumberEUPAS10165
Official titlePredictors of treatment choice in patients with COPD
Study title acronym
Study typeObservational study
Brief description of the studyA retrospective observational cohort study that investigates predictors of initial treatment choice in COPD patients.
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 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 signed03/02/2014
Start date of data collection17/02/2014
Start date of data analysis
Date of interim report, if expected
Date of final study report01/09/2015
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesNovartis Pharmaceuticals100
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)4401223967855
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)4401223967855
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
Chronic obstructive pulmonary disease
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 subjects20154
10. Source of data
Is this study being carried out with an established data source?No
Sources of data
Routine primary care electronic patient registry
11. Scope of the study
What is the scope of the study?
Disease epidemiology
Drug utilisation study
Primary scope : Disease epidemiology
12. Main objective(s)
What is the main objective of the study?
To examine the changes in prescriptions patterns over time, in order to determine the potential driving factors behind GP prescribing for newly diagnosed COPD patients.
Are there primary outcomes?Yes
Primary outcome will identify predictors of GP prescribing behaviour when treating newly diagnosed COPD patients with their first pharmacological therapy. It will assess the odds of being prescribed:
• any initial COPD therapy vs.
• no COPD therapy
A further analysis will be conduted in regard to the odds of being prescribed:
• maintenance therapy versus
• short-acting agents/no therapy
Are there secondary outcomes?Yes
To obtain the data required for exploring the primary outcomes, exploratories will be conducted to investigate the distribution of COPD pharmacological therapy in the main potential predictors (see appendix for full list). Results will be summarised and tested using chi-square to identify whether variation occurs among the categories.
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
Baseline characterisation of patients, summary statistics as a complete dataset and by treatment groups.
Logistic regression analysis for all patients receiving first COPD therapy.
Evaluate how the potential predictors outlined above could affect the choice of initial COPD therapy in terms of:
a. Odds of being prescribed any initial COPD therapy vs. no therapy
b. Odds of receiving initial COPD maintenance therapy vs. short-acting agents/no therapy
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
