The aim of the RESPECT study is to gain a better understanding of the prevalence, pathogenesis and symptoms of early chronic obstructive pulmonary disease (COPD). This study seeks to address the following specific objectives/research questions: 1) to estimate the prevalence of airflow limitation (AL) and COPD in adults 35-70 years of age in St.Petersburg and Arkhangelsk based on sex, age, environmental conditions, socioeconomic status and smoking status; 2) to compare the prevalence of COPD in the study population based on the Global Strategy for Diagnosis, Management and Prevention of COPD (GOLD) and lower limit of normal (LLN) criteria; 3) to identify the diagnostic value of various signs, symptoms and background characteristics for the diagnosis of COPD; 4) to determine whether differences in background characteristics and inflammatory biomarkers are evident between smokers with and without COPD; and 5) to describe co-morbidity, functionality and global health status in a cohort of newly diagnosed COPD patients.
Two northwestern of Russian Federation (RF) cities (St.Petersburg and Arkhangelsk) were selected for the RESPECT study. Fifteen primary care centers were invited to participate in this study. Fifteen investigators (10 from St.Petersburg and 5 from Arkhangelsk) were recruited (predominantly doctors and two highly educated nurses). All investigators received study information, including a detailed study protocol and recent guidelines on COPD, and participated in a three-week course on spirometry and the clinical diagnosis and management of obstructive lung diseases. The sample size was calculated based on two goals: 1) to determine a reliable estimate of the prevalence of COPD and 2) to estimate the diagnostic value of symptoms with an acceptable confidence interval. The sample size for the RESPECT study was estimated using 2828 subjects (based on an 8% prevalence of COPD in RF). Assuming an anticipated refusal rate of 20%, 3500 participants from St.Petersburg and 1500 from Arkhangelsk were invited to participate in this study. The analyses will include cross-sectional and prospective approaches. Prospective analyses will be performed on the entire cohort.
Study Type
OBSERVATIONAL
Enrollment
3,133
City Policlinic Number 2
Arkhangelsk, Russia
Family medicine center
Saint Petersburg, Russia
Change of lung function parameter (FEV1/FVC (Forced Vital Capacity) and FEV1)
Evolution of lung function parameters
Time frame: Change from Baseline FEV1/FVC and FEV1 at 1 year
Change of positive predictive value of signs and symptoms
diagnostic value of signs and symptoms (positive predictive value)
Time frame: Change from Baseline signs and symptoms at 1 year
Change of inflammatory parameters
inflammatory profiles (biomarkers)
Time frame: Change from Baseline inflammatory parameters at 1 year
Comorbidities (comorbidities for COPD)
number of comorbidities for COPD
Time frame: Change from Baseline number of comorbidities at 1 year
Change of health status (The change in health status by the Questionnaire of the EuroQol Group Association)
The change in health status by the Questionnaire of the EuroQol Group Association
Time frame: Change from Baseline Health Status at 1 year
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