Back to resultsChronic Obstructive Pulmonary Disease in Combination With Atherosclerosis (Clinical and Biochemical Study)
Primary Purpose
Chronic Obstructive Pulmonary Disease, Peripheral Artery Disease
Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Breath Condensate Collection
clinical examination, spirometry
blood monocyte assay
Sponsored by
About this trial
This is an interventional screening trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, peripheral atherosclerosis, comorbidity
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Ryazan State Medical University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Experimental
Other
Arm Label
The natural history of COPD
Study of systemic inflammation and molecular mechanisms
Exhaled breath condensate
Arm Description
Monitoring risk factors, chronic respiratory symptoms and respiratory function in the natural history of chronic obstructive pulmonary disease
Study of systemic inflammation and molecular mechanisms underlying the comorbid course of COPD and atherosclerosis
A study of the clinical and biochemical COPD phenotype with systemic inflammation and comorbidity
Outcomes
Primary Outcome Measures
mortality
the number of deaths from cardiovascular causes
lung function
progression of decreased lung function (FEV1%) according to spirometry
exacerbations
frequency of exacerbations of COPD (number of cases per year)
markers of inflammation
biochemical markers of inflammation (IL-6, pg/ml; IL-8,pg/ml;TNF,pg/ml)
Secondary Outcome Measures
Full Information
NCT ID
NCT04474717
First Posted
June 29, 2020
Last Updated
July 20, 2023
Sponsor
Ryazan State Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04474717
Brief Title
Chronic Obstructive Pulmonary Disease in Combination With Atherosclerosis (Clinical and Biochemical Study)
Official Title
Clinical and Biochemical Assessment of the Course of Chronic Obstructive Pulmonary Disease in Combination With Atherosclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 15, 2020 (Actual)
Primary Completion Date
July 19, 2023 (Actual)
Study Completion Date
July 19, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ryazan State Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Peripheral Artery Disease
Keywords
COPD, peripheral atherosclerosis, comorbidity
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
476 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The natural history of COPD
Arm Type
Other
Arm Description
Monitoring risk factors, chronic respiratory symptoms and respiratory function in the natural history of chronic obstructive pulmonary disease
Arm Title
Study of systemic inflammation and molecular mechanisms
Arm Type
Experimental
Arm Description
Study of systemic inflammation and molecular mechanisms underlying the comorbid course of COPD and atherosclerosis
Arm Title
Exhaled breath condensate
Arm Type
Other
Arm Description
A study of the clinical and biochemical COPD phenotype with systemic inflammation and comorbidity
Intervention Type
Diagnostic Test
Intervention Name(s)
Breath Condensate Collection
Intervention Description
Breath Condensate Collection
Intervention Type
Diagnostic Test
Intervention Name(s)
clinical examination, spirometry
Intervention Description
spirometry
Intervention Type
Diagnostic Test
Intervention Name(s)
blood monocyte assay
Intervention Description
study of blood monocytes in the laboratory of cell technology
Primary Outcome Measure Information:
Title
mortality
Description
the number of deaths from cardiovascular causes
Time Frame
12 months
Title
lung function
Description
progression of decreased lung function (FEV1%) according to spirometry
Time Frame
12 months
Title
exacerbations
Description
frequency of exacerbations of COPD (number of cases per year)
Time Frame
12 months
Title
markers of inflammation
Description
biochemical markers of inflammation (IL-6, pg/ml; IL-8,pg/ml;TNF,pg/ml)
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Facility Information:
Facility Name
Ryazan State Medical University
City
Ryazan
State/Province
Please Select
ZIP/Postal Code
390005
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Chronic Obstructive Pulmonary Disease in Combination With Atherosclerosis (Clinical and Biochemical Study)
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