Early detection of COPD patients in GOLD 0 population: an observational non-interventional cohort study - MARKO study

Abstract

BackgroundMain risk factor for the development of chronic obstructive pulmonary disease (COPD) is smoking, although only less than 1/3 of smokers develop clinically manifest COPD. COPD’s progressive nature with high disability and mortality makes it plausible to detect it as early as possible thus allowing for an early intervention. The only tool for an early diagnosis that could be used on the global scale is spirometry, even though symptoms and deprivation of health related quality of life (HRQoL) precede relevant spirometric changes. Existing HRQoL questionnaires are too complicated or not developed for an early detection of COPD. The aim of our study was to develop a new simple HRQoL tool that will allow (alone or in combination with other markers) early detection of patients with COPD.MethodsA multicenter prospective cohort study recruiting 500 subjects at risk for COPD (smokers/ex-smokers ≥20 pack-years, 40–65 years, both sexes, with no prior diagnosis of COPD) will be carried out in two phases: (1) cross-sectional - development and validation of a new questionnaire; and (2) prospective - follow-up of a cohort of patients at risk for COPD. Subjects were recruited by 25 GPs and assessed for COPD by dedicated pulmonologists in 7 hospital centers using a predefined protocol: HRQoL, history, physical, blood sampling, exhaled breath temperature (EBT), lung function, 6-min walk test (6MWT). Patients without COPD and those in GOLD stage 1 at initial assessment will be reassessed for disease progression by the same pulmonologist after 2 and 5 years.DiscussionThis is one of the first cohort studies attempting to establish the incidence of COPD in the pre-symptomatic stage before significant end organ damage. We intend to assess the validity, predictability and discriminative power (‘healthy’ smokers vs. pre-symptomatic phase in newly developed COPD) of newly developed HRQoL tool alone or in combination with other markers; EBT, lung function, 6MWT, genomics, transcriptomics, proteomics). We expect that the results of this study can improve our understanding of the development of COPD, identify some new underlying pathophysiological pathways, and offer to sensitive smokers/ex-smokers new preventive and early intervention measures thus improving the management of COPD.Trial registrationClinicaltrial.gov NCT01550679 retrospectively registered February 28, 2012.

Review of recent lung biomarkers of potential harm/effect for tobacco research

“…Most studies on EBT have been performed in asthmatic patients to assess changes in the degree of airway inflammation (Paredi et al, 2002, Piacentini et al, 2002, Piacentini et al, 2007. Some studies also evaluated EBT as a potential biomarker in smoking and COPD (Carpagnano et al, 2016, Hoffmeyer et al, 2009, Lázár et al, 2014, Popov et al, 2017, Vrbica et al, 2017.…”

Breathlessness and “exacerbation” questions predictive for incident COPD (MARKO study): data after two years of follow-up

“…So one of the aims of the MARKO project (Early detection of COPD patients in GOLD 0 (smokers) population–MARKO project) ( Vrbica et al, 2017 ) and this analysis was to assess the predictability of MARKO questionnaire for incident COPD during the 2-years follow-up.…”

Rationale and design of the Early Chronic Obstructive Pulmonary Disease (ECOPD) study in Guangdong, China: a prospective observational cohort study

“…At present, the cohorts for studying high-risk groups for COPD and early COPD mainly include the COPDGene study (13), SPIROMICS study (14), CanCOLD study (15), SOON study (16), FOOTPRINTS study (17), and MARKO cohort (18). However, these cohort studies have only included current smokers and have not included nonsmokers.…”