Status: Finalised
First registered on:
09/09/2015
Last updated on:
23/10/2018
1. Study identification
EU PAS Register NumberEUPAS10923
Official titleEffectiveness of prescribing similar vs dissimilar devices for COPD management (phase 2)
Study title acronym
Study typeObservational study
Brief description of the studyEffectiveness of prescribing similar vs dissimilar devices for COPD management (phase 2):
− Compare the effectiveness (in terms of moderate and severe exacerbation prevention) of prescribing inhaler devices with similar inhalation techniques vs prescribing devices with dissimilar inhalation techniques in patients with COPD
− Assess therapy adherence in patients with COPD prescribed inhaler devices with similar inhalation techniques vs patients prescribed devices with dissimilar inhalation techniques
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
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed18/06/201508/04/2016
Start date of data collection28/08/201528/08/2015
Start date of data analysis14/09/2015
Date of interim report, if expected25/01/2016
Date of final study report08/02/201608/04/2016
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 1University of Aberdeen
Address line 2
Address line 3
CityAberdeen
PostcodeAB24 3FX
CountryUnited Kingdom
Phone number (incl. country code)441223967855
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)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)Yes
Chronic obstructive pulmonary disease
8. Population under study
Age
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects53817
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?
Effectiveness evaluation
Primary scope : Effectiveness evaluation
12. Main objective(s)
What is the main objective of the study?
-Compare the effectiveness (in terms of moderate and severe exacerbation prevention) of prescribing inhaler devices with similar inhalation techniques vs prescribing devices with dissimilar inhalation techniques in patients with COPD
−Assess therapy adherence in patients with COPD prescribed inhaler devices with similar inhalation techni
Are there primary outcomes?Yes
•Moderate and severe COPD exacerbation rate (sensitivity definition)
Are there secondary outcomes?Yes
•Short-acting beta2agonist (SABA) use
•Adherence to COPD therapy
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
Phase 2 of the study will investigate the effectiveness of comparable vs. non-comparable devices (as categorised in phase 1) in terms of excaerbation rate, SABA use and adherence to COPD therapy.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
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
