The RESPECT study: RESearch on the PrEvalence and the diagnosis of COPD and its Tobacco-related etiology: a study protocol.

BACKGROUND

Smoking remains a leading health risk factor among Europeans. Tobacco, together with other factors, will lead to an expansive epidemic of chronic diseases, including COPD, among the working population in Russia. The general aim of the RESearch on the PrEvalence and the diagnosis of COPD and its Tobacco-related etiology (RESPECT) study is to gain a better understanding of the prevalence, pathogenesis and symptoms of COPD.

METHODS/DESIGN: The RESPECT study is a prospective, population-based cohort study of subjects aged 35-70 years in two north-west regions of the Russian Federation (Saint Petersburg and Arkhangelsk). The study includes three components: a cross-sectional study (prevalence), a case-control study and a cohort study (diagnostic). An investigator who interviewed the patient completed three questionnaires. Spirometry, including a reversibility test, was offered to all participants. Individuals displaying forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) < 0.7 and/or FEV1/FVC < the lower limit of normal before and/or after bronchodilation were included in a follow-up study and were examined by a pulmonologist using a standardized comprehensive examination protocol. A future case-control study of two matched groups of patients (heavy smokers with COPD versus heavy smokers without COPD) will provide information on which factors (biomarkers, including pneumoproteins, in serum and induced sputum) are related to tobacco-induced COPD.

DISCUSSION

In total, 3133 individuals (2122 from St. Petersburg and 1012 from Arkhangelsk) aged 35-70 years agreed to participate in this study and met the inclusion criteria. In total, 2974 participants met the quality criteria for spirometry, and 2388 reversibility tests were performed. A cohort of newly defined obstructive pulmonary disease patients (247 persons) was established for follow-up investigation. The RESPECT study will provide information regarding the prevalence of COPD in the north-west region of the Russian Federation. Moreover, the comprehensive RESPECT database will enable us to explore new research questions, provide novel insight into the risk factors and different phenotypes of COPD, and contribute to an improved understanding of the reasons why some heavy smokers develop the disease whereas others do not.

CLINICAL TRIAL REGISTRATION

NCT02307799 (the release date: 12/01/2014).