Status: Finalised
First registered on:
22/10/2014
Last updated on:
18/02/2019
1. Study identification
EU PAS Register NumberEUPAS7727
Official titleRandomised Controlled Trial (RCT) vs Real Life initiative
Study title acronymRCT vs Real Life
Study typeOther: systematic evaluation study
Brief description of the studyTo determine the proportion of patients with COPD in the community who would meet inclusion/exclusion criteria of recently registered RCTs of long-acting bronchodilator therapy and to compare characteristics of COPD patients in OPCRD with those from individual RCTs
Was this study requested by a regulator?No
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 signed17/07/2014
Start date of data collection13/08/201406/10/2014
Start date of data analysis10/11/201408/12/2014
Date of interim report, if expected
Date of final study report15/12/201411/03/2015
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBoehringer Ingelheim100
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 (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects36893
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources not registered with ENCePP
OPCRD, United Kingdom
Sources of data
Routine primary care electronic patient registry
11. Scope of the study
What is the scope of the study?
review /evaluation other studies
Primary scope : review /evaluation other studies
12. Main objective(s)
What is the main objective of the study?
To determine the proportion of patients with COPD in the Optimum Patients Care Research database (OPCRD) who would meet the inclusion and exclusion criteria to participate in recent RCTs of inhaled long-acting bronchodilator therapy.
Are there primary outcomes?No
Are there secondary outcomes?No
13. Study design
What is the design of the study?
systematic evaluation 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
Description of percentages of total OPCRD population of patients with COPD who would be eligbile for RCTs.
Compare characteristics of eligible OPCRD population with reported characteristics of patients participating to RCT
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
Halpin, D.M., Kerkhof, M., Soriano, J.B., Mikkelsen, H. and Price, D.B., 2016. Eligibility of real-life patients with COPD for inclusion in trials of inhaled long-acting bronchodilator therapy. Respiratory research, 17(1), p.120.https://respiratory-research.biomedcentral.com/articles/10.1186/s12931-016-0433-5
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
