Chronic Obstructive Pulmonary Disease in Combination With Atherosclerosis (Clinical and Biochemical Study)

Clinical and Biochemical Assessment of the Course of Chronic Obstructive Pulmonary Disease in Combination With Atherosclerosis

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04474717

Enrollment

476

Registered

2020-07-17

Start date

2020-11-15

Completion date

2023-07-19

Last updated

2023-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease, Peripheral Artery Disease

Keywords

COPD, peripheral atherosclerosis, comorbidity

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.

Interventions

DIAGNOSTIC_TESTBreath Condensate Collection

Breath Condensate Collection

DIAGNOSTIC_TESTclinical examination, spirometry

spirometry

DIAGNOSTIC_TESTblood monocyte assay

study of blood monocytes in the laboratory of cell technology

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. A significant diagnosis of COPD, confirmed by spirometry criteria, typical clinical presentation. 2. A significant diagnosis of peripheral atherosclerosis 3. The high level of adherence to treatment 4. Signed informed agreement

Exclusion criteria

1. The presence of other chronic respiratory diseases in the patient, including bronchial asthma 2. Known oncological diseases of any localization 3. HIV infection and other immunodeficiency conditions 4. Inability to understand and comply with the requirements of the research protocol.

Design outcomes

Primary

Measure	Time frame	Description
mortality	12 months	the number of deaths from cardiovascular causes
lung function	12 months	progression of decreased lung function (FEV1%) according to spirometry
exacerbations	12 months	frequency of exacerbations of COPD (number of cases per year)
markers of inflammation	12 months	biochemical markers of inflammation (IL-6, pg/ml; IL-8,pg/ml;TNF,pg/ml)

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026