<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04474717</url>
  </required_header>
  <id_info>
    <org_study_id>15.06.2020</org_study_id>
    <nct_id>NCT04474717</nct_id>
  </id_info>
  <brief_title>Chronic Obstructive Pulmonary Disease in Combination With Atherosclerosis (Clinical and Biochemical Study)</brief_title>
  <official_title>Clinical and Biochemical Assessment of the Course of Chronic Obstructive Pulmonary Disease in Combination With Atherosclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ryazan State Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ryazan State Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      one-centered, open, non-randomized, controlled clinical trial will focus on a comprehensive&#xD;
      study of the clinical, functional and molecular biochemical characteristics of the natural&#xD;
      course of COPD in combination with peripheral atherosclerosis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Risk factors, chronic respiratory symptoms and respiratory function in the natural history of&#xD;
      COPD will be monitored. In a group of patients with a comorbid course of COPD and&#xD;
      atherosclerosis, systemic inflammation and its molecular mechanisms will be investigated.&#xD;
      Also in this group, the role of non-coding miRNAs will be analyzed. The study also includes&#xD;
      an analysis of the clinical and biochemical COPD phenotype with systemic inflammation and&#xD;
      comorbidity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 15, 2020</start_date>
  <completion_date type="Actual">July 19, 2023</completion_date>
  <primary_completion_date type="Actual">July 19, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>mortality</measure>
    <time_frame>12 months</time_frame>
    <description>the number of deaths from cardiovascular causes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>lung function</measure>
    <time_frame>12 months</time_frame>
    <description>progression of decreased lung function (FEV1%) according to spirometry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>exacerbations</measure>
    <time_frame>12 months</time_frame>
    <description>frequency of exacerbations of COPD (number of cases per year)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>markers of inflammation</measure>
    <time_frame>12 months</time_frame>
    <description>biochemical markers of inflammation (IL-6, pg/ml; IL-8,pg/ml;TNF,pg/ml)</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">476</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <condition>Peripheral Artery Disease</condition>
  <arm_group>
    <arm_group_label>The natural history of COPD</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Monitoring risk factors, chronic respiratory symptoms and respiratory function in the natural history of chronic obstructive pulmonary disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study of systemic inflammation and molecular mechanisms</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study of systemic inflammation and molecular mechanisms underlying the comorbid course of COPD and atherosclerosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exhaled breath condensate</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>A study of the clinical and biochemical COPD phenotype with systemic inflammation and comorbidity</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Breath Condensate Collection</intervention_name>
    <description>Breath Condensate Collection</description>
    <arm_group_label>Exhaled breath condensate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>clinical examination, spirometry</intervention_name>
    <description>spirometry</description>
    <arm_group_label>The natural history of COPD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>blood monocyte assay</intervention_name>
    <description>study of blood monocytes in the laboratory of cell technology</description>
    <arm_group_label>Study of systemic inflammation and molecular mechanisms</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. A significant diagnosis of COPD, confirmed by spirometry criteria, typical clinical&#xD;
             presentation.&#xD;
&#xD;
          2. A significant diagnosis of peripheral atherosclerosis&#xD;
&#xD;
          3. The high level of adherence to treatment&#xD;
&#xD;
          4. Signed informed agreement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The presence of other chronic respiratory diseases in the patient, including bronchial&#xD;
             asthma&#xD;
&#xD;
          2. Known oncological diseases of any localization&#xD;
&#xD;
          3. HIV infection and other immunodeficiency conditions&#xD;
&#xD;
          4. Inability to understand and comply with the requirements of the research protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ryazan State Medical University</name>
      <address>
        <city>Ryazan</city>
        <state>Please Select</state>
        <zip>390005</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>July 20, 2023</last_update_submitted>
  <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COPD</keyword>
  <keyword>peripheral atherosclerosis</keyword>
  <keyword>comorbidity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    <mesh_term>Atherosclerosis</mesh_term>
    <mesh_term>Peripheral Arterial Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04474717
org study id: 15.06.2020
nct id: NCT04474717
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: mortality
time frame: 12 months
description: the number of deaths from cardiovascular causes
measure: lung function
time frame: 12 months
description: progression of decreased lung function (FEV1%) according to spirometry
measure: exacerbations
time frame: 12 months
description: frequency of exacerbations of COPD (number of cases per year)
measure: markers of inflammation
time frame: 12 months
description: biochemical markers of inflammation (IL-6, pg/ml; IL-8,pg/ml;TNF,pg/ml)
arm group label: The natural history of COPD
arm group type: Other
description: Monitoring risk factors, chronic respiratory symptoms and respiratory function in the natural history of chronic obstructive pulmonary disease
arm group label: Study of systemic inflammation and molecular mechanisms
arm group type: Experimental
description: Study of systemic inflammation and molecular mechanisms underlying the comorbid course of COPD and atherosclerosis
arm group label: Exhaled breath condensate
arm group type: Other
description: A study of the clinical and biochemical COPD phenotype with systemic inflammation and comorbidity
intervention type: Diagnostic Test
intervention name: Breath Condensate Collection
description: Breath Condensate Collection
arm group label: Exhaled breath condensate
intervention type: Diagnostic Test
intervention name: clinical examination, spirometry
description: spirometry
arm group label: The natural history of COPD
intervention type: Diagnostic Test
intervention name: blood monocyte assay
description: study of blood monocytes in the laboratory of cell technology
arm group label: Study of systemic inflammation and molecular mechanisms
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Russian Federation
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Atherosclerosis
mesh term: Peripheral Arterial Disease
sharing ipd: No