1. Study identification
EU PAS Register NumberEUPAS29401
Official titleAdvancing the Patient Experience in COPD Registry
Study title acronymAPEX COPD
Study typeObservational study
Brief description of the studyThe initiative aims to improve primary care for COPD patients. It will bring together electronic medical records with patient reported information and observations, and present this to clinicians in a structured and clinically relevant format at the point of care. This will be achieved using modern technology, including FHIR, electronic patient surveys, and standardized data collection, and will be guided by a network of COPD physicians in primary and secondary care. Impact will be maximised through Research publications regarding treatment effectiveness and associated risk in mild to moderate COPD, reason for therapy switch/escalation and hidden undiagnosed and untreated COPD patients in primary care. A strong network of COPD primary care physicians in the US is driving the initiative and will ensure impact on clinical practice through academic organisations and research outputs.
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
Centre nameOptimum Patient Care Ltd
Centre location5 Coles Lane, Oakington, CB24 3BA, Cambridge, United Kingdom
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?
Yes
DARTNet Institute
Other centres where this study is being conducted
Not applicable (single centre)
Countries in which this study is being conducted
National study
United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed27/12/201827/12/2018
Start date of data collection01/07/2019
Start date of data analysis02/09/2019
Date of interim report, if expected
Date of final study report29/12/2023
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBoehringer Ingelheim, Inc.40
Charities
Government body
Research councils
EU funding scheme
OtherOptimum Patient Care Ltd.60
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Price
First name David
Address line 15 Coles Lane
Address line 2
Address line 3
CityCambridge
PostcodeCB24 3BA
CountryUnited Kingdom
Phone number (incl. country code)44-1223-967855
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Professor
Last name Price
First name David
Address line 15 Coles Lane
Address line 2
Address line 3
CityCambridge
PostcodeCB24 3BA
CountryUnited Kingdom
Phone number (incl. country code)44-1223-967855
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 subjects3000
10. Source of data
Is this study being carried out with an established data source?No
Sources of data
Prospective patient-based data collection
Disease/case registry
11. Scope of the study
What is the scope of the study?
Disease epidemiology
Effectiveness evaluation
Quality improvement
Primary scope : Disease epidemiology
12. Main objective(s)
What is the main objective of the study?
Describe and characterise the COPD primary care patient population natural history overall and by different subgroups, and evaluate the comparative clinical, safety and cost effectiveness of current COPD treatments by class of therapy for COPD overall and in specific patient groups/phenotypes, to understand the predictors of response to available COPD treatment options.
Are there primary outcomes?No
Are there secondary outcomes?No
13. Study design
What is the design of the study?
Longitudinal registry study
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
All enrolled patients will be followed-up annually during routine clinical
visits for a total duration of up to four years. Additional follow-up will occur at any additional COPD related clinic visits.
15. Data analysis plan
Please provide a brief summary of the analysis method
Describing the natural history of COPD in the US
Phenotyping COPD sub-groups
Examining significant predictors of clinical outcomes