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Completed

NCT Number: NCT02307799

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

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.

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Key information

Conditions

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

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

City Policlinic Number 2, Arkhangelsk, Russia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change of lung function parameter (FEV1/FVC (Forced Vital Capacity) and FEV1)

    Time frame: Change from Baseline FEV1/FVC and FEV1 at 1 year

    Evolution of lung function parameters

Secondary outcomes

  1. Change of positive predictive value of signs and symptoms

    Time frame: Change from Baseline signs and symptoms at 1 year

    diagnostic value of signs and symptoms (positive predictive value)

  2. Change of inflammatory parameters

    Time frame: Change from Baseline inflammatory parameters at 1 year

    inflammatory profiles (biomarkers)

  3. Comorbidities (comorbidities for COPD)

    Time frame: Change from Baseline number of comorbidities at 1 year

    number of comorbidities for COPD

  4. Change of health status (The change in health status by the Questionnaire of the EuroQol Group Association)

    Time frame: Change from Baseline Health Status at 1 year

    The change in health status by the Questionnaire of the EuroQol Group Association

Sponsors and collaborators

Lead sponsor

Université Catholique de Louvain

Other

Collaborators

  • Northern State Medical University

Registry information

Official study title

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

Acronym: RESPECT

Important dates

Study start
2012
Primary completion
2018
Study completion
2019
First posted
Dec 4, 2014
Registry last updated
Jan 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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