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Proposal 1779

Title of the Proposed Research

Evaluation of the effect of inhaled corticosteroids (ICS) on blood eosinophil count (EOS) in patients with COPD

Lead Researcher

Professor Jørgen Vestbo DMSc FRCP FERS

Affiliation

Division of Infection, Immunity and Respiratory Medicine
University of Manchester, UK

Funding Source

AGM research time is funded by National Institute for Health Research (NIHR), via an Academic Clinical Fellowship in Respiratory Medicine.

Potential Conflicts of Interest

Prof Vestbo has received personal fees not related to this study from GlaxoSmithKline, Chiesi Pharmaceuticals, Boehringer-Ingelheim, Novartis and AstraZeneca.

Data Sharing Agreement Date

27 November 2017

Lay Summary

Background:
In patients with COPD, inhaled corticosteroids (ICS) decrease the frequency of exacerbations and improve lung function and quality of life, at the expense of a number of significant side effects, such as a high risk of pneumonia, osteoporosis and diabetes.

Recent studies suggested that ICS might only be effective in COPD patients with high blood eosinophil count (EOS), who represent approximately 30-40% of all COPD patients. Confirmation of this observation would lead to a more targeted and limited use of ICS. However, results of the previously mentioned studies were weak or inconsistent and cannot -yet- be translated into clinical practice.

These studies included different proportions of patients who were using ICS at the time when EOS levels were measured. However, a previous study clearly demonstrated that sputum EOS are significantly suppressed by the administration of ICS. It is also known that blood and sputum EOS counts are correlated in COPD patients. Therefore, it is likely that ICS might also suppress the levels of blood eosinophil count. If that is the case, in all previous studies, the ability of EOS to predict response to ICS might have been partly concealed by the suppression of their levels among patients who were receiving ICS at the time of the measurement.

Aims:
- To evaluate whether the administration of ICS significantly suppresses EOS count.
- To assess whether EOS count measured while COPD patients (1) are not receiving or (2) are receiving ICS can more accurately predict responsiveness to ICS.
- Finally, to identify cut-point EOS values to guide administration of ICS.

Methods:
- In the duration of the selected trials, many participants discontinued and/or initiated ICS. We will compare the EOS counts when receiving/not receiving ICS to assess whether ICS significantly suppress EOS count.
- Next, we will test whether EOS count measured while patients are or are not receiving ICS can better predict responsiveness to ICS.
- Finally, we will then evaluate which EOS cut-point is more accurate in predicting responsiveness to ICS.

Interpretation:
Our study hypothesis is that EOS count must be measured while patients are not receiving ICS, in order to predict responsiveness to ICS. Confirmation of our hypothesis will tackle a significant clinical problem and will enable clinicians to limit and target the administration of ICS.

Communication with patients/public:
We will prepare a plain English summary of our results and we will distribute it to European Lung Foundation and British Lung Foundation for distribution to their members. We will also promote it in paper and electronic press (non-professional).

Study Data Provided

GSK-SCO104925: A randomized, double-blind placebo-controlled study of treatments with salmeterol, fluticasone propionate and their combination to evaluate novel endpoints in patients with chronic obstructive pulmonary disease
GSK-FLTB3054 (FLIT78) [ISOLDE]: A multicentre, double-blind, placebo-controlled, parallel group study of the efficacy and tolerability of long-term inhaled fluticasone propionate 500mg twice daily via a Volumatic Spacer device in patients with non-asthmatic chronic obstructive pulmonary disease, including…

Statistical Analysis Plan

Publication Citation

The publication citation will be added after the research is published.

Summary Results

Results summary or link will be posted when available.