A RESearch on the PrEvalence and the Diagnosis of COPD and Its Tobacco-related Etiology

Chronic Obstructive Pulmonary Disease Clinical Trial

— RESPECT  

Official title:

A RESearch on the PrEvalence and the Diagnosis of COPD and Its Tobacco-related Etiology (RESPECT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02307799
• Other study ID #: RESPECT2014
• Status: Completed
• Start date: June 2012
• Est. completion date: January 2019

Study information

• Verified date: January 2019
• Source: Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3133
• Est. completion date: January 2019
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

Inclusion Criteria:

•written consent to participate

Inclusion criteria for the cohort component:

•100 newly detected persons with FEV1/FVC less than 0.7 or less than LLN before and after reversibility test.

Inclusion criteria for the case-control component:

Both for cases and controls:

•A smoking history of more than 10 pack-years based on pack/year criteria

Test cases will include 100 participants that meet the following criteria:

• Smokers aged 35-70 years with a smoking history of >10 pack-years.

• Completely irreversible airway obstruction based on the following criteria: FEV1/FVC < 0.70 according to GOLD criteria or FEV1/FVC < LLN.

Test controls will include 100 participants based on the following criteria:

•Smokers aged 35-70 years with a smoking history of >10 pack/years and without COPD according to GOLD or LLN criteria, without asthma (absence of symptoms), with a negative history of allergies, and free from use of bronchodilators.

Exclusion Criteria:

• COPD exacerbation during last 3 months

• Patient did not sign an informed consent

• Patient refuses to participate

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Russian Federation	City Policlinic Number 2	Arkhangelsk
Russian Federation	Family medicine center	Saint Petersburg

Sponsors (2)

Lead Sponsor	Collaborator
Université Catholique de Louvain	Northern State Medical University

Country where clinical trial is conducted

Russian Federation, 

References & Publications (3)

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. — View Citation

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. E — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Change of positive predictive value of signs and symptoms	diagnostic value of signs and symptoms (positive predictive value)	Change from Baseline signs and symptoms at 1 year
Secondary	Change of inflammatory parameters	inflammatory profiles (biomarkers)	Change from Baseline inflammatory parameters at 1 year
Secondary	Comorbidities (comorbidities for COPD)	number of comorbidities for COPD	Change from Baseline number of comorbidities at 1 year
Secondary	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	Change from Baseline Health Status at 1 year