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

July 20, 2023 updated by: Ryazan State Medical University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

476

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
    • Please Select
      • Ryazan, Please Select, Russian Federation, 390005
        • Ryazan State Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ryazan State Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2020

Primary Completion (Actual)

July 19, 2023

Study Completion (Actual)

July 19, 2023

Study Registration Dates

First Submitted

June 29, 2020

First Submitted That Met QC Criteria

July 13, 2020

First Posted (Actual)

July 17, 2020

Study Record Updates

Last Update Posted (Estimated)

July 24, 2023

Last Update Submitted That Met QC Criteria

July 20, 2023

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15.06.2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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