Clinical and Biochemical Assessment of the Course of Chronic Obstructive Pulmonary Disease in Combination With Atherosclerosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 476
- Locations
- 1
- Primary Endpoint
- mortality
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Arms & Interventions
The natural history of COPD
Monitoring risk factors, chronic respiratory symptoms and respiratory function in the natural history of chronic obstructive pulmonary disease
Intervention: clinical examination, spirometry (Diagnostic Test)
Study of systemic inflammation and molecular mechanisms
Study of systemic inflammation and molecular mechanisms underlying the comorbid course of COPD and atherosclerosis
Intervention: blood monocyte assay (Diagnostic Test)
Exhaled breath condensate
A study of the clinical and biochemical COPD phenotype with systemic inflammation and comorbidity
Intervention: Breath Condensate Collection (Diagnostic Test)
Outcomes
Primary Outcomes
mortality
Time Frame: 12 months
the number of deaths from cardiovascular causes
exacerbations
Time Frame: 12 months
frequency of exacerbations of COPD (number of cases per year)
markers of inflammation
Time Frame: 12 months
biochemical markers of inflammation (IL-6, pg/ml; IL-8,pg/ml;TNF,pg/ml)
lung function
Time Frame: 12 months
progression of decreased lung function (FEV1%) according to spirometry
Secondary Outcomes
No secondary outcomes reported