Status: Ongoing First registered on: 31/01/2017
Last updated on: 31/01/2017
1. Study identification
EU PAS Register NumberEUPAS17543
Official titleBurden of disease in patients with COPD and high blood eosinophil counts
Study title acronymHigh eosinophils and COPD
Study typeObservational study
Brief description of the studyPatients with COPD with high blood eosinophil counts (BEC) have an increased risk of exacerbations. This study aims to evaluate the role of high BEC measured during stable disease in the burden and costs of COPD in a broad real-life population of patients in the United Kingdom. An observational historical follow-up study will be performed using medical records data for patients (aged ≥40 years) with COPD, from the Optimum Patient Care Research Database (OPCRD) and the Clinical Practice Research Datalink (CPRD) The study has the following objectives: 1.To study the association between high BEC at the time of stable COPD (i.e., no recent exacerbation and stable treatment during the study period) and the prospective exacerbation rate in different subgroups of patients with COPD defined by treatment regimen and smoking habits and to study whether this association is also found in patients with good adherence to ICS 2. To study whether patients admitted to hospital for COPD exacerbation are more likely to be re-admitted if their pre-admission BEC is high 3. A. To estimate mean all-cause and COPD-related health care resource use (HRU) and associated costs in 4 subgroups of patients who are at risk of exacerbations (i.e. a history of ≥2 exacerbations or ≥1 exacerbation leading to hospitalisation in the past 12 months) while receiving treatment with triple therapy, where the 4 subgroups are defined by the presence or absence of high BEC and current smoking habits B. to compare HRU and costs with those for the total population of patients with COPD who have BECs available 4.To study whether the presence of high BEC is associated with greater all-cause and COPD-related costs in the subsequent year and to study which other easily accessible characteristics drive future costs in patients with COPD.
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 to which the investigator belongsOPRI Pte Ltd
Department/Research groupObservational and Pragmatic Research Institute Pte Ltd
Organisation/affiliationOPRI Pte Ltd
Website/Homepagewww.opri.sg
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 signed01/08/201601/08/2016
Start date of data collection15/09/201617/11/2016
Start date of data analysis03/10/201631/01/2017
Date of interim report, if expected16/12/2016
Date of final study report17/04/2017
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)441223967582 
Alternative phone number 
Fax number (incl. country code) 
Email address marjan@opri.sg
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)441223967582 
Alternative phone number 
Fax number (incl. country code) 
Email address marjan@opri.sg 
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