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

NCT04474717 | Completed

• 1 other identifier: 15.06.2020
• Study Type: interventional
• Target: 476
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Obstructive Pulmonary Disease; Peripheral Artery Disease

Keywords

COPD; peripheral atherosclerosis; comorbidity

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

The natural history of COPD

OTHER

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

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

Diagnostic Test: blood monocyte assay

Exhaled breath condensate

OTHER

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

Diagnostic Test: Breath Condensate Collection

Interventions

Breath Condensate Collection DIAGNOSTIC_TEST

Breath Condensate Collection

Exhaled breath condensate

clinical examination, spirometry DIAGNOSTIC_TEST

spirometry

The natural history of COPD

blood monocyte assay DIAGNOSTIC_TEST

study of blood monocytes in the laboratory of cell technology

Study of systemic inflammation and molecular mechanisms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ryazan State Medical University: lead

Study Sites (1)

Ryazan State Medical University

Ryazan, Please Select, 390005, Russia

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Peripheral Arterial Disease

Interventions

Physical Examination; Spirometry

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 17, 2020
• Study Start: November 15, 2020
• Primary Completion: July 19, 2023
• Study Completion: July 19, 2023
• Last Updated: July 24, 2023

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)