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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04474717
• Other study ID #: 15.06.2020
• Status: Completed
• Phase: N/A
• Start date: November 15, 2020
• Est. completion date: July 19, 2023

Study information

• Verified date: June 2021
• Source: Ryazan State Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 476
• Est. completion date: July 19, 2023
• Est. primary completion date: July 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis
• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Peripheral Arterial Disease
• Peripheral Artery Disease
• Pulmonary Disease, Chronic Obstructive

Intervention

Diagnostic Test:
• Breath Condensate Collection
Breath Condensate Collection
• clinical examination, spirometry
spirometry
• blood monocyte assay
study of blood monocytes in the laboratory of cell technology

Locations

Country	Name	City	State
Russian Federation	Ryazan State Medical University	Ryazan	Please Select

Sponsors (1)

Lead Sponsor	Collaborator
Ryazan State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

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