Chronic Obstructive Pulmonary DiseaseNCT04474717
Chronic Obstructive Pulmonary Disease in Combination With Atherosclerosis (Clinical and Biochemical Study)
A study testing Breath Condensate Collection, clinical examination, spirometry and blood monocyte assay in people with Chronic Obstructive Pulmonary Disease and Peripheral Artery Disease, run by Ryazan State Medical University at 1 site in Russia.
Trial summary
one-centered, open, non-randomized, controlled clinical trial will focus on a comprehensive study of the clinical, functional and molecular biochemical characteristics of the natural course of COPD in combination with peripheral atherosclerosis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Peripheral Artery Disease
- What is being tested?
- Breath Condensate Collection, clinical examination, spirometry and blood monocyte assay
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 476 participants
- Where
- 1 siteRussia
- Study dates
- 15 Nov 2020to 19 Jul 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A significant diagnosis of COPD, confirmed by spirometry criteria, typical clinical presentation.
- A significant diagnosis of peripheral atherosclerosis
- The high level of adherence to treatment
- Signed informed agreement
Who cannot join
- The presence of other chronic respiratory diseases in the patient, including bronchial asthma
- Known oncological diseases of any localization
- HIV infection and other immunodeficiency conditions
- Inability to understand and comply with the requirements of the research protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Biochemical Assessment of the Course of Chronic Obstructive Pulmonary Disease in Combination With Atherosclerosis
one-centered, open, non-randomized, controlled clinical trial will focus on a comprehensive study of the clinical, functional and molecular biochemical characteristics of the natural course of COPD in combination with peripheral atherosclerosis
Read the detailed description
Risk factors, chronic respiratory symptoms and respiratory function in the natural history of COPD will be monitored. In a group of patients with a comorbid course of COPD and atherosclerosis, systemic inflammation and its molecular mechanisms will be investigated. Also in this group, the role of non-coding miRNAs will be analyzed. The study also includes an analysis of the clinical and biochemical COPD phenotype with systemic inflammation and comorbidity.
- Being tested
- Breath Condensate Collection, clinical examination, spirometry, blood monocyte assay
- Keywords
- COPD, peripheral atherosclerosis, comorbidity
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath Condensate CollectionDiagnostic test
Breath Condensate Collection
clinical examination, spirometryDiagnostic test
spirometry
blood monocyte assayDiagnostic test
study of blood monocytes in the laboratory of cell technology
| Study group | Role | What they receive |
|---|---|---|
| The natural history of COPD | Other | Monitoring risk factors, chronic respiratory symptoms and respiratory function in the natural history of chronic obstructive pulmonary disease Receives: Diagnostic Test: clinical examination, spirometry |
| Study of systemic inflammation and molecular mechanisms | Experimental | Study of systemic inflammation and molecular mechanisms underlying the comorbid course of COPD and atherosclerosis Receives: Diagnostic Test: blood monocyte assay |
| Exhaled breath condensate | Other | A study of the clinical and biochemical COPD phenotype with systemic inflammation and comorbidity Receives: Diagnostic Test: Breath Condensate Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
the number of deaths from cardiovascular causes
Measured: 12 months
lung function
progression of decreased lung function (FEV1%) according to spirometry
Measured: 12 months
exacerbations
frequency of exacerbations of COPD (number of cases per year)
Measured: 12 months
markers of inflammation
biochemical markers of inflammation (IL-6, pg/ml; IL-8,pg/ml;TNF,pg/ml)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start15 Nov 2020
- Primary completion19 Jul 2023
- Study completion19 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 476 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ryazan State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04474717
- Sponsor's protocol ID
- 15.06.2020
- Status last verified
- Jun 2021
- First submitted
- 29 Jun 2020
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Biochemical Assessment of the Course of Chronic Obstructive Pulmonary Disease in Combination With Atherosclerosis
- ClinicalTrials.gov ID
- NCT04474717
- Acronym / sponsor ID
- 15.06.2020
- Keywords
- COPD, peripheral atherosclerosis, comorbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 476 participants (actual)
- Lead sponsor
- Ryazan State Medical UniversityUniversity, hospital or other
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 19 Jul 2023 (actual)
- Study completion
- 19 Jul 2023 (actual)
- First posted
- 17 Jul 2020 (actual)
- 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.
one-centered, open, non-randomized, controlled clinical trial will focus on a comprehensive study of the clinical, functional and molecular biochemical characteristics of the natural course of COPD in combination with peripheral atherosclerosis
Detailed description
Risk factors, chronic respiratory symptoms and respiratory function in the natural history of COPD will be monitored. In a group of patients with a comorbid course of COPD and atherosclerosis, systemic inflammation and its molecular mechanisms will be investigated. Also in this group, the role of non-coding miRNAs will be analyzed. The study also includes an analysis of the clinical and biochemical COPD phenotype with systemic inflammation and comorbidity.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The natural history of COPD | Other | Diagnostic Test: clinical examination, spirometryMonitoring risk factors, chronic respiratory symptoms and respiratory function in the natural history of chronic obstructive pulmonary disease |
| Study of systemic inflammation and molecular mechanisms | Experimental | Diagnostic Test: blood monocyte assayStudy of systemic inflammation and molecular mechanisms underlying the comorbid course of COPD and atherosclerosis |
| Exhaled breath condensate | Other | Diagnostic Test: Breath Condensate CollectionA study of the clinical and biochemical COPD phenotype with systemic inflammation and comorbidity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A significant diagnosis of COPD, confirmed by spirometry criteria, typical clinical presentation.
- A significant diagnosis of peripheral atherosclerosis
- The high level of adherence to treatment
- Signed informed agreement
Key exclusion criteria (4 listed)
- The presence of other chronic respiratory diseases in the patient, including bronchial asthma
- Known oncological diseases of any localization
- HIV infection and other immunodeficiency conditions
- Inability to understand and comply with the requirements of the research protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breath Condensate CollectionBreath Condensate Collection | Diagnostic test | Exhaled breath condensate |
| clinical examination, spirometryspirometry | Diagnostic test | The natural history of COPD |
| blood monocyte assaystudy of blood monocytes in the laboratory of cell technology | Diagnostic test | Study of systemic inflammation and molecular mechanisms |
Primary outcome
mortality
Time frame: 12 months
the number of deaths from cardiovascular causes
lung function
Time frame: 12 months
progression of decreased lung function (FEV1%) according to spirometry
exacerbations
Time frame: 12 months
frequency of exacerbations of COPD (number of cases per year)
markers of inflammation
Time frame: 12 months
biochemical markers of inflammation (IL-6, pg/ml; IL-8,pg/ml;TNF,pg/ml)
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 24 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breath Condensate Collection, clinical examination, spirometry and blood monocyte assay in people with Chronic Obstructive Pulmonary Disease and Peripheral Artery Disease, run by Ryazan State Medical University at 1 site 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 4 inclusion and 4 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 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
mortality (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2023.