Investigating the possible role of BLood eosinophil counts in guiding ANti-inflammatory treatment of COPD exAcerbations (BLANCA)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/26154
• EU PAS number:
  EUPAS16875
• Study ID:
  26154
• Official title and acronym:
  Investigating the possible role of BLood eosinophil counts in guiding ANti-inflammatory treatment of COPD exAcerbations (BLANCA)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  A 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.
• Study status:
  Finalised

Research institutions and networks

Institutions

Observational & Pragmatic Research Institute Pte (OPRI)

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 09/12/2016

Actual: 09/12/2016

Study start date

Planned: 27/12/2016

Actual: 27/12/2016

Data analysis start date

Planned: 06/01/2017

Actual: 06/01/2017

Date of final study report

Planned: 15/05/2018

Actual: 24/04/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable