Chronic Obstructive Pulmonary Disease (COPD) Biomarker Identification Study: Serum Lipidomics

The overall clinical study used a parallel-group, case-controlled study design in order to identify a biomarker or panel of biomarkers for the differentiation of subjects with mild to moderate COPD (GOLD stage I and II), asymptomatic current smokers, former smokers and never-smokers and to compare physiological measurements and quality of life (QoL) across the study groups. The study was conducted between July 2011 and December 2012, at a single clinical site in London, UK, after approval from a UK National Health Service (NHS) ethics committee (The Black County Ethics Committee) and in strict compliance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines. The study has been registered on ClinicalTrials.gov with identifier NCT01780298. Male and female subjects aged between 41 and 70 years were enrolled with a completed total subject number of 60 per group. During the course of the study, sputum, blood, and nasal samples were collected and a number of physiological and clinical measurements were recorded from a total of 240 subjects. Each subject in each of the 3 control groups, namely the healthy smokers, never-smokers and ex-smokers, were matched to subjects in the COPD group by age (+/-5 years), ethnicity, gender, and all smoking subjects had a smoking history of at least 10 pack-years. The study subject were required to attend the study visits after having eaten a light breakfast. Analyses of lipid species were performed in serum samples from a subset of study subjects including 40 never-smokers, 40 former smokers, 40 smokers, and 40 COPD patients by Zora Biosciences Oy (Espoo, Finland). The data from this analysis are reported here.