Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
A RESearch on the PrEvalence and the Diagnosis of COPD and Its Tobacco-related Etiology (RESPECT)
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.
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