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

NCT02307799 | Completed

• 1 other identifier: RESPECT2014
• Study Type: observational
• Target: 3,133
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

tobacco; spirometry; cohort study; case-control study; prevalence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• COPD exacerbation during last 3 months
• Patient did not sign an informed consent
• Patient refuses to participate

Sponsors & Collaborators

• Université Catholique de Louvain: lead
• Northern State Medical University: collaborator

Study Sites (2)

City Policlinic Number 2

Arkhangelsk, 163009, Russia

Location

Family medicine center

Saint Petersburg, 194291, Russia

Location

Related Publications (4)

• 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.

  PMID: 26315949 BACKGROUND

• 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.

  PMID: 26727503 RESULT

• 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.

  PMID: 29138407 RESULT

• 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.

  PMID: 34527321 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-Marie Degryse, professor

  Université Catholique de Louvain, Brussels, Belgium

  PRINCIPAL INVESTIGATOR

• Olga Yu Kuznetsova, professor

  North-West State Medical University, St Petersburg, Russia

  PRINCIPAL INVESTIGATOR

• Elena A Andreeva, PhD

  Northern State Medical University, Arkhangelsk, Russia

  PRINCIPAL INVESTIGATOR

• Marina A Pokhaznikova, PhD

  North-West State Medical University, St Petersburg, Russia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 26, 2014
• First Posted: December 4, 2014
• Study Start: June 1, 2012
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2019
• Last Updated: January 23, 2019

Record last verified: 2019-01

Locations

RU (2)