Burden of disease in patients with COPD and high blood eosinophil counts (High eosinophils and COPD)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/17544
• EU PAS number:
  EUPAS17543
• Study ID:
  17544
• Official title and acronym:
  Burden of disease in patients with COPD and high blood eosinophil counts (High eosinophils and COPD)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Patients 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 ICS2. To study whether patients admitted to hospital for COPD exacerbation are more likely to be re-admitted if their pre-admission BEC is high3. 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 habitsB. to compare HRU and costs with those for the total population of patients with COPD who have BECs available4.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.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Observational & Pragmatic Research Institute Pte (OPRI)

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 01/08/2016

Actual: 01/08/2016

Study start date

Planned: 15/09/2016

Actual: 17/11/2016

Data analysis start date

Planned: 03/10/2016

Actual: 31/01/2017

Date of interim report, if expected

Planned: 16/12/2016

Date of final study report

Planned: 17/04/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca

Study protocol

Initial protocol

161207_R03315_Non-intervention study protocol_Burden of eosinophilic COPD V3.1

Regulatory

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