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

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease; Peripheral Artery Disease
• Interventions: Diagnostic Test: Breath Condensate Collection; Diagnostic Test: clinical examination, spirometry; Diagnostic Test: blood monocyte assay

• Registration Number: NCT04474717
• Lead Sponsor: Ryazan State Medical University

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.

Study Timeline

• Study First Submitted: 2020-06-29
• Study First Submitted QC: 2020-07-13
• Study First Posted: 2020-07-17
• Study Start: 2020-11-15
• Status Verified: 2021-06
• Primary Completion: 2023-07-19
• Study Completion: 2023-07-19
• Last Update Submitted: 2023-07-20
• Last Update Posted: 2023-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 476

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exhaled breath condensate	Breath Condensate Collection	A study of the clinical and biochemical COPD phenotype with systemic inflammation and comorbidity
The natural history of COPD	clinical examination, spirometry	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	blood monocyte assay	Study of systemic inflammation and molecular mechanisms underlying the comorbid course of COPD and atherosclerosis

Primary Outcome Measures

Name	Time	Method
mortality	12 months	the number of deaths from cardiovascular causes
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)
lung function	12 months	progression of decreased lung function (FEV1%) according to spirometry

Trial Locations

Locations (1)

Ryazan State Medical University; 🇷🇺 Ryazan, Please Select, Russian Federation