Chronic Obstructive Pulmonary DiseaseRESPECTNCT02307799
A RESearch on the PrEvalence and the Diagnosis of COPD and Its Tobacco-related Etiology
An observational study of Chronic Obstructive Pulmonary Disease, run by Université Catholique de Louvain at 2 sites in Russia.
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… Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 3,133 participants
- Where
- 2 sitesRussia
- Study dates
- Jun 2012to Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- •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.
Show all 9Show fewer
- 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.
Who cannot join
- COPD exacerbation during last 3 months
- Patient did not sign an informed consent
- Patient refuses to participate
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
City Policlinic Number 2
Arkhangelsk, 163009
Family medicine center
Saint Petersburg, 194291
About this study
Official title: A RESearch on the PrEvalence and the Diagnosis of COPD and Its Tobacco-related Etiology (RESPECT)
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- tobacco, spirometry, cohort study, case-control study, prevalence
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of lung function parameter (FEV1/FVC (Forced Vital Capacity) and FEV1)
Evolution of lung function parameters
Measured: Change from Baseline FEV1/FVC and FEV1 at 1 year
Secondary outcomes (4)
Change of positive predictive value of signs and symptoms
diagnostic value of signs and symptoms (positive predictive value)
Measured: Change from Baseline signs and symptoms at 1 year
Change of inflammatory parameters
inflammatory profiles (biomarkers)
Measured: Change from Baseline inflammatory parameters at 1 year
Comorbidities (comorbidities for COPD)
number of comorbidities for COPD
Measured: 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)
The change in health status by the Questionnaire of the EuroQol Group Association
Measured: Change from Baseline Health Status at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startJun 2012
- Primary completionJan 2018
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Collaborators
- Northern State Medical University
- Responsible party
- Principal investigator, Jean-Marie Degryse, Université Catholique de Louvain
- Investigators
- Jean-Marie Degryse, professor, Principal investigator, Université Catholique de Louvain, Brussels, BelgiumOlga Yu Kuznetsova, professor, Principal investigator, North-West State Medical University, St Petersburg, RussiaElena A Andreeva, PhD, Principal investigator, Northern State Medical University, Arkhangelsk, RussiaMarina A Pokhaznikova, PhD, Principal investigator, North-West State Medical University, St Petersburg, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02307799
- Sponsor's protocol ID
- RESPECT2014
- Acronym
- RESPECT
- Status last verified
- Jan 2019
- First submitted
- 26 Nov 2014
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26315949Andreeva 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.
PubMed 26727503Andreeva 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.
PubMed 29138407Andreeva 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.
PubMed 34527321
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RESearch on the PrEvalence and the Diagnosis of COPD and Its Tobacco-related Etiology (RESPECT)
- ClinicalTrials.gov ID
- NCT02307799
- Acronym / sponsor ID
- RESPECT / RESPECT2014
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- tobacco, spirometry, cohort study, case-control study, prevalence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,133 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- Northern State Medical University
- Study start
- Jun 2012
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 4 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- •written consent to participate
- •100 newly detected persons with FEV1/FVC less than 0.7 or less than LLN before and after reversibility test.
- •A smoking history of more than 10 pack-years based on pack/year 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.
Key exclusion criteria (3 listed)
- COPD exacerbation during last 3 months
- Patient did not sign an informed consent
- Patient refuses to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
Change of positive predictive value of signs and symptoms
Time frame: Change from Baseline signs and symptoms at 1 year
Change of inflammatory parameters
Time frame: Change from Baseline inflammatory parameters at 1 year
Comorbidities (comorbidities for COPD)
Time frame: 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)
Time frame: Change from Baseline Health Status at 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Background: PubMed 26315949Andreeva 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.
- Results publication: PubMed 26727503Andreeva 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.
- Results publication: PubMed 29138407Andreeva 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.
- Derived from this study: PubMed 34527321Andreeva 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Marie Degryse, professor principal investigator
Université Catholique de Louvain, Brussels, Belgium
Olga Yu Kuznetsova, professor principal investigator
North-West State Medical University, St Petersburg, Russia
Elena A Andreeva, PhD principal investigator
Northern State Medical University, Arkhangelsk, Russia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Université Catholique de Louvain at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of lung function parameter (FEV1/FVC (Forced Vital Capacity) and FEV1) (time frame: Change from Baseline FEV1/FVC and FEV1 at 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02307799, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019.