NCT02307799|Completed
A RESearch on the PrEvalence and the Diagnosis of COPD and Its Tobacco-related Etiology
RESPECT
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RESPECT
Sponsor study identifier
observational
3,133
1 country
2
Study Start
June 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2018
Actual (reported)Study Completion
January 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2019
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2012
Date type not reportedThis date has not been verified as actual or estimated.
November 26, 2014
Actual (reported)December 4, 2014
Actual (reported)January 2018
Actual (reported)January 2019
Actual (reported)Change of lung function parameter (FEV1/FVC (Forced Vital Capacity) and FEV1)
Evolution of lung function parameters
Change from Baseline FEV1/FVC and FEV1 at 1 year
Change of positive predictive value of signs and symptoms
Change from Baseline signs and symptoms at 1 year
Change of inflammatory parameters
Change from Baseline inflammatory parameters at 1 year
Comorbidities (comorbidities for COPD)
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)
Change from Baseline Health Status at 1 year
First component: The study population was randomly selected from the lists of the 15 participating centers (these patient lists are organized based on territories). Second component (cohort study): All newly identified individuals with airflow limitation before and/or after the reversibility test were included in the cohort study. Third component: One hundred patients with COPD and a smoking history of more than 10 pack-years (cases) and one hundred patients with the same smoking history without COPD (controls) will be included in the third study.
City Policlinic Number 2
Arkhangelsk, 163009, Russia
Family medicine center
Saint Petersburg, 194291, Russia
Andreeva E, Pokhaznikova M, Lebedev A, Moiseeva I, Kozlov A, Kuznetsova O, Degryse JM. The RESPECT study: RESearch on the PrEvalence and the diagnosis of COPD and its Tobacco-related etiology: a study protocol. BMC Public Health. 2015 Aug 28;15:831. doi: 10.1186/s12889-015-2161-z.
Andreeva E, Pokhaznikova M, Lebedev A, Moiseeva I, Kutznetsova O, Degryse JM. The Prevalence of Chronic Obstructive Pulmonary Disease by the Global Lung Initiative Equations in North-Western Russia. Respiration. 2016;91(1):43-55. doi: 10.1159/000442887. Epub 2016 Jan 5.
Jean-Marie Degryse, professor
Université Catholique de Louvain, Brussels, Belgium
Olga Yu Kuznetsova, professor
North-West State Medical University, St Petersburg, Russia
Elena A Andreeva, PhD
Northern State Medical University, Arkhangelsk, Russia
Marina A Pokhaznikova, PhD
North-West State Medical University, St Petersburg, Russia
3,133 participants (actual enrollment reported by the registry).
First Submitted
November 26, 2014
First Posted
December 4, 2014
Study Start
June 2012
Date type not reportedThis date has not been verified as actual or estimated.
Non-interventional Study of Spirometry Use to Diagnose COPD (Chronic Obstructive Pulmonary Disease) and to Prescribe Treatment to COPD Patients in the Outpatient Institutions
Contact the study team to confirm eligibility.
Andreeva E, Pokhaznikova M, Lebedev A, Moiseeva I, Kuznetsova O, Degryse JM. Spirometry is not enough to diagnose COPD in epidemiological studies: a follow-up study. NPJ Prim Care Respir Med. 2017 Nov 14;27(1):62. doi: 10.1038/s41533-017-0062-6.
Andreeva E, Pokhasnikova M, Lebedev A, Moiseeva I, Kozlov A, Kuznetsova O, Degryse JM. Inflammatory parameters and pulmonary biomarkers in smokers with and without chronic obstructive pulmonary disease (COPD). J Thorac Dis. 2021 Aug;13(8):4812-4829. doi: 10.21037/jtd-20-1580.
Primary Completion
January 2018
Actual (reported)Study Completion
January 2019
Actual (reported)Last Updated
January 23, 2019
Record last verified: 2019-01
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