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

Study Overview
=================
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.

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

Conditions
-----------------
Chronic Obstructive Pulmonary Disease, Peripheral Artery Disease

Intervention / Treatment
-----------------
* Diagnostic Test: Breath Condensate Collection
* Diagnostic Test: clinical examination, spirometry
* Diagnostic Test: blood monocyte assay


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: The natural history of COPD<br>Monitoring risk factors, chronic respiratory symptoms and respiratory function in the natural history of chronic obstructive pulmonary disease | Diagnostic Test: clinical examination, spirometry<br>* spirometry<br>|
| Experimental: Study of systemic inflammation and molecular mechanisms<br>Study of systemic inflammation and molecular mechanisms underlying the comorbid course of COPD and atherosclerosis | Diagnostic Test: blood monocyte assay<br>* study of blood monocytes in the laboratory of cell technology<br>|
| Other: Exhaled breath condensate<br>A study of the clinical and biochemical COPD phenotype with systemic inflammation and comorbidity | Diagnostic Test: Breath Condensate Collection<br>* Breath Condensate Collection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, peripheral atherosclerosis, comorbidity