Status: Finalised
First registered on:
20/12/2016
Last updated on:
17/10/2018
1. Study identification
EU PAS Register NumberEUPAS16875
Official titleInvestigating the possible role of BLood eosinophil counts in guiding ANti-inflammatory treatment of COPD exAcerbations (BLANCA)
Study title acronym
Study typeObservational study
Brief description of the studyA matched historical database study among patients with COPD in the UK will be conducted. The index date is defined as the date of any exacerbation with a blood eosinophil count measurement available on the same day and with a one-year baseline and at least 6 weeks post index date. A dataset of unique patients from the Optimum Patient Care Research Database (OPCRD) will be used for analyses. Moreover, the Clinical Practice Research Datalink (CPRD) will be used to increase the number of available patients fitting the inclusion and exclusion criteria. The dataset from both the sources will be combined and duplicate records will be removed. A combined dataset of unique patients will be used for all the analyses. The study population will consist of patients with a COPD diagnostic Read code, with blood eosinophil counts recorded on an exacerbation date with no OCS and antibiotic use during the 2 weeks before the event and registered at general practices providing data to OPCRD (or CPRD) across the United Kingdom.
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 signed09/12/201609/12/2016
Start date of data collection27/12/201627/12/2016
Start date of data analysis06/01/201706/01/2017
Date of interim report, if expected
Date of final study report15/05/201824/04/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAstraZeneca100
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 15a Coles Lane
Address line 2Oakington
Address line 3
CityCambridge
PostcodeCB24 3BA
CountryUnited Kingdom
Phone number (incl. country code)440-1223967582
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Professor
Last name Price
First name David
Address line 15a Coles Lane
Address line 2Oakington
Address line 3
CityCambridge
PostcodeCB24 3BA
CountryUnited Kingdom
Phone number (incl. country code)440-1223967582
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)No
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 subjects2500
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
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?
To study whether COPD patients with high blood eosinophil counts at the time of exacerbation prescribed oral corticosteroids with/without antibiotics experience decreased treatment failure as compared to those not prescribed oral corticosteroids.
Are there primary outcomes?Yes
The primary outcome is treatment failure (to be studied for 6 weeks outcome period), defined as additional prescription of antibiotic or oral corticosteroids course or respiratory-related accident and emergency (A&E) attendance or respiratory-related hospital attendance / admission.
Are there secondary outcomes?Yes
The secondary outcome is healthcare resource utilisation in the outcome period of 6 weeks and additionally at a 1 year outcome period for both high blood eosinophil and non-high blood eosinophil patients treated with and without oral corticosteroids.
13. Study design
What is the design of the study?
Cross-sectional study
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
6 weeks
15. Data analysis plan
Please provide a brief summary of the analysis method
Exact matching for categorical variables and matching within a maximum calliper for continuous variables will be used to match patients using nearest neighbour variable mixed matching with a match maximum of 3:1 on the variables predictive of outcomes, without replacement. Multiple observations can exist for the same patient, but each observation will only be used once during the matching process.
The odds of experiencing treatment failure as defined above in patients prescribed oral corticosteroids with/without antibiotics will be compared to those not prescribed oral corticosteroids. A conditional logistic regression analysis in the matched cohorts will be performed to study whether the association between therapy option and outcomes is modified by the blood eosinophil level, adjusted for variables causing residual confounding. In addition, conditional cox proportional hazard regression will be used to assess how therapy option is associated with time to hospital admission.
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
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
