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

Study type
Protocol
Date of Approval
Study reference ID
16_297
Lay Summary

Chronic obstructive pulmonary disease (COPD), is a lung disease that causes a gradual decrease in lung function and associated with abnormal inflammatory responses. It is the 3rd leading cause of death worldwide, and the 2nd most common lung disease in the United Kingdom (UK). Although COPD is usually thought of as causing increased production of neutrophils (most abundant white blood cells), raised levels of eosinophils in blood and phlegm were detected in 10-40% of COPD patients during stable disease. Eosinophilic COPD patients have a different physical composition that appears to be associated with higher responsiveness to corticosteroids (anti-inflammatory medication prescribed for COPD treatment) during worsening of COPD conditions. Hence, a real-life database study like this in larger patient population would provide more evidence on the association of blood eosinophil levels with the response to corticosteroid treatment during worsening of COPD symptoms. In addition, database studies will allow healthcare resource utilisation (HRU) between treatments to be studied.
The aim of this study is to evaluate whether high blood eosinophil counts at the time of worsening symptoms affects treatment failure in patients with COPD treated with oral corticosteroids.

Technical Summary

Patients with COPD may experience increased frequency in exacerbations with worsening disease severity. Acute exacerbations are one of the primary manifestations of COPD and account for 50–75% of the costs associated with the disease. The clinical diagnosis of an exacerbation in COPD indicates an acute worsening of lung function and symptoms that may require change in regular treatment.
Although COPD is generally thought of as neutrophilic, recently different inflammatory profiles have been identified. It is now believed that eosinophilic COPD patients represent a different phenotype that responds better to corticosteroid treatment. Antibiotics with/without oral corticosteroids are commonly used in the treatment of moderate and severe COPD exacerbations. The degree of eosinophilic inflammation is related to the degree of OCS improvement in lung function and health status.
Studies suggest that anti-inflammatory treatment in patients with higher blood eosinophils results in favourable outcomes, whereas failure to treat with anti-inflammatory prescriptions results in high treatment failure. Although OCS are relatively inexpensive to prescribe, they are associated with significant long term side effects which, in turn, are associated with significant healthcare resource costs.

Collaborators

David Price - Chief Investigator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Mandy Ow - Corresponding Applicant - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Shreyasee Karnik - Corresponding Applicant - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Carole Nicholls - Collaborator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Derek Skinner - Collaborator - Research in Real Life ltd.( RiRl )
Gopalan Gokul - Collaborator - Astra Zeneca Inc - USA
Marianna Alacqua - Collaborator - Astra Zeneca Inc - USA
Sadia Halim - Collaborator - Astra Zeneca Inc - USA
Sarang Rastogi - Collaborator - Astra Zeneca Inc - USA

Linkages

HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient