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

Ryazan State Medical University

Status: Completed

Conditions: Peripheral Artery Disease; Chronic Obstructive Pulmonary Disease

Treatments: Diagnostic Test: Breath Condensate Collection; Diagnostic Test: clinical examination, spirometry; Diagnostic Test: blood monocyte assay

Study type: Interventional

Funder types: Other

Identifiers

NCT04474717

15.06.2020

Details and patient eligibility

About

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

Full 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.

Enrollment: 476 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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476 participants in 3 patient groups

The natural history of COPD

Other group

Description:

Monitoring risk factors, chronic respiratory symptoms and respiratory function in the natural history of chronic obstructive pulmonary disease

Treatment:

Diagnostic Test: clinical examination, spirometry

Study of systemic inflammation and molecular mechanisms

Experimental group

Description:

Study of systemic inflammation and molecular mechanisms underlying the comorbid course of COPD and atherosclerosis

Treatment:

Diagnostic Test: blood monocyte assay

Exhaled breath condensate

Other group

Description:

A study of the clinical and biochemical COPD phenotype with systemic inflammation and comorbidity

Treatment:

Diagnostic Test: Breath Condensate Collection