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

Completed

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT02307799
• Lead Sponsor: Université Catholique de Louvain

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2014-11-26
• Study First Submitted QC: 2014-12-01
• Study First Posted: 2014-12-04
• Primary Completion: 2018-01
• Status Verified: 2019-01
• Study Completion: 2019-01
• Last Update Submitted: 2019-01-19
• Last Update Posted: 2019-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3133

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of lung function parameter (FEV1/FVC (Forced Vital Capacity) and FEV1)	Change from Baseline FEV1/FVC and FEV1 at 1 year	Evolution of lung function parameters

Secondary Outcome Measures

Name	Time	Method
Change of positive predictive value of signs and symptoms	Change from Baseline signs and symptoms at 1 year	diagnostic value of signs and symptoms (positive predictive value)
Change of inflammatory parameters	Change from Baseline inflammatory parameters at 1 year	inflammatory profiles (biomarkers)
Comorbidities (comorbidities for COPD)	Change from Baseline number of comorbidities at 1 year	number of comorbidities for COPD
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	The change in health status by the Questionnaire of the EuroQol Group Association

Trial Locations

Locations (2)

Family medicine center; 🇷🇺 Saint Petersburg, Russian Federation

City Policlinic Number 2; 🇷🇺 Arkhangelsk, Russian Federation