Inhaled corticosteroids, blood eosinophils and lung function (FEV1) decline over time in a primary care COPD cohort

Study type
Protocol
Date of Approval
Study reference ID
17_229
Lay Summary

Lung function tests relate to how well our lungs work and measure such things as how much air our lungs can hold and how easily we can breathe in and out. All individuals have some decline in lung function over time, particularly in later life. People with chronic obstructive pulmonary disease (COPD) lose lung function faster than the general population, particularly those who continue to smoke. Lower lung function is associated with premature death and may lead to the inability to perform simple physical tasks such as walking short distances unaided. To date people with COPD are treated with short or long-acting bronchodilator inhalers at the first instance and with inhaled corticosteroids (ICS) if symptoms persist. However, over the last few years there has been debate over whether the benefits of ICS therapy outweigh the harms in COPD patients and whether these benefits vary by subgroups of COPD patients. A subgroup of interest is those with high blood eosinophils. Using statistical models, we will describe how lung function changes in COPD patients over time and see whether there is a difference in lung function decline between patients with high and low blood eosinophils who are on and not on ICS.

Technical Summary

People with COPD are commonly treated with short or long-acting bronchodilator inhalers. If symptoms persist or patients experience exacerbations of COPD they are put onto inhaled corticosteroids (ICS). However, the risks and benefits of ICS in the treatment of COPD patients have long been debated. Randomized clinical and observational studies have shown that the use of ICS in COPD patients can increase the chances of respiratory infections as well as that they reduce rehospitalisation and exacerbations of COPD. More recently, it is thought that specific subgroups of COPD patients may benefit from ICS treatment more than others. High blood eosinophil counts in COPD patients is one subgroup of interest. This study aims to assess the effect of ICS on lung function decline, particularly FEV1, in a primary care COPD population, stratifying by blood eosinophil levels. Using a mixed effects linear model, we will investigate the decline in lung function in people with prevalent COPD over a 10 year period and compare the rates of decline in patients with high or low eosinophils, who are on and not on ICS to explore who may benefit more from ICS.

Collaborators

Jennifer Quint - Chief Investigator - Imperial College London
Hannah Whittaker - Corresponding Applicant - Imperial College London
Hana Mullerova - Collaborator - AstraZeneca Ltd - UK Headquarters
Steven Kiddle - Collaborator - AstraZeneca Ltd - UK Headquarters

Linkages

HES Admitted Patient Care;Patient Level Index of Multiple Deprivation