<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/NCT04456491</url>
  </required_header>
  <id_info>
    <org_study_id>ASCONO</org_study_id>
    <nct_id>NCT04456491</nct_id>
  </id_info>
  <brief_title>The Clinical Value of the Nitric Oxide System Components in Asthma and COPD</brief_title>
  <acronym>ASCONO</acronym>
  <official_title>The Clinical Value of the Nitric Oxide System Components in Asthma and Chronic Obstructive Pulmonary Disease</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>
      It is planned to conduct a study of nitric oxide metabolites (nitrates and nitrites),&#xD;
      L-arginine, arginase-1, and asymmetric dimethylarginine in patients with bronchial asthma and&#xD;
      chronic obstructive pulmonary disease, followed by observation to assess the prognosis of the&#xD;
      disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic obstructive pulmonary disease and bronchial asthma have a leading position among&#xD;
      respiratory diseases. A significant contribution to the clinical picture and long-term&#xD;
      prognosis is made by exacerbations of COPD, which makes it relevant to search for methods for&#xD;
      their prediction and prevention. According to the global initiative on bronchial asthma&#xD;
      (GINA), bronchial asthma is characterized by high heterogeneity and the existence of many&#xD;
      phenotypes and endotypes, which makes it relevant to use personalized medicine methods in&#xD;
      patient management and, in particularly, the search for new biomarkers of asthma. Currently,&#xD;
      in clinical practice, some biomarkers of obstructive lung diseases are widely used. Among&#xD;
      them there are the level of eosinophils in the blood and sputum, the level of immunoglobulin&#xD;
      E and the exhaled fraction of nitric oxide (FeNO). Obstructive lung diseases are&#xD;
      characterized by persistent inflammation in the airways, which is accompanied by the&#xD;
      manifestation of elements of systemic inflammation and endothelial dysfunction, which is&#xD;
      associated with an altered release of vasoactive mediators, one of them is nitric oxide (NO).&#xD;
      NO is a powerful vasodilator that is synthesized from L-arginine using the enzyme NO synthase&#xD;
      (NOS). The NO molecule has small lifetime from 3 to 30 s, that's why the search for&#xD;
      biomarkers with a more stable lifetime is relevant. Some of them it's nitric oxide&#xD;
      metabolites, such as nitrates (NO3-), nitrites (NO2-), S-nitrosothiols, 3-nitrotyrosine.&#xD;
      Nitrates and nitrites, which are metabolites of nitric oxide, may be of interest as one of&#xD;
      the promising biochemical markers reflecting NO metabolism in the human body. Earlier in our&#xD;
      study, the relationship between the plasma level of nitric oxide metabolites and the severity&#xD;
      of bronchial asthma was shown, which may be a prerequisite for further study of the&#xD;
      components of the nitric oxide system as potential biomarkers of bronchial obstructive&#xD;
      diseases.&#xD;
&#xD;
      A promising direction in the search for biomarkers related to the nitric oxide system is the&#xD;
      study of L-arginine, which acts as a substrate in the reaction of NO formation. The&#xD;
      bioavailability of L-arginine for NO synthases determines the activity of formation of nitric&#xD;
      oxide in the respiratory tract, as evidenced by the effect of inhaled L-arginine on the level&#xD;
      of exhaled fraction of nitric oxide. Earlier, in a US study, 26 patients with bronchial&#xD;
      asthma showed a significant decrease in plasma L-arginine levels compared with healthy&#xD;
      volunteers, and laboratory animal models showed that a decrease in L-arginine levels leads to&#xD;
      airway hyperreactivity. Currently, a number of pilot clinical interventional studies have&#xD;
      been carried out in which the administration of L-arginine improved the manifestations of&#xD;
      bronchial asthma in some patients, but did not change the frequency of exacerbations in the&#xD;
      total sample of patients. This indicates the possible existence of an endotype of bronchial&#xD;
      asthma associated with impaired functioning of the nitric oxide system, and makes it&#xD;
      promising to study the level of L-arginine in the blood as a potential biomarker of&#xD;
      obstructive lung diseases.&#xD;
&#xD;
      In addition to studying nitric oxide metabolites, substances that affect the formation of NO&#xD;
      should be considered as potential biomarkers of the disease. One such substance is arginase,&#xD;
      under the influence of which L-arginine is converted into L-ornithine and urea. In humans,&#xD;
      two isoenzymes of arginase, arginase 1 and arginase 2, have been identified, which differ in&#xD;
      cellular location and tissue distribution. Both arginase enzymes are expressed in the airways&#xD;
      and can be found in endothelial and epithelial cells, fibroblasts, macrophages, and smooth&#xD;
      muscle cells of the respiratory tract. Further metabolism of L-ornithine leads to the&#xD;
      formation of polyamines and L-proline, which are involved in cell proliferation and&#xD;
      differentiation, as well as in the production of collagen. Scientists have shown that&#xD;
      increased arginase activity in the airways contributes to airway obstruction and&#xD;
      hyperreactivity by decreasing the availability substrate for NOS. As a result, the production&#xD;
      of NO decreases and superoxides form, which react with NO to form peroxynitrite, thereby&#xD;
      increasing airway contractility and inflammation. In addition, increased airway arginase&#xD;
      activity leads to an increase in L-ornithine production, which potentially contributes to&#xD;
      airway remodeling due to stimulation of cell proliferation and collagen formation.&#xD;
&#xD;
      The metabolism of L-arginine depends not only on arginase, but also on the methyltransferase&#xD;
      enzyme, which methylates L-arginine residues, which undergo proteolysis with the formation of&#xD;
      asymmetric and symmetric dimethylarginine (ADMA and SDMA). These amino acids inhibit NOS&#xD;
      activity, since ADMA is a competitive inhibitor of the enzyme, while SDMA is a competitor to&#xD;
      L-arginine transport. Serum ADMA and SDMA, as well as L-arginine concentrations increase with&#xD;
      COPD and increase further with the development of exacerbation. It is important to note that&#xD;
      the concentration of ADMA in blood serum is probably an independent risk factor for long-term&#xD;
      mortality from all causes in obstructive lung diseases and is associated with increased&#xD;
      airway resistance. In recent years, several studies have been conducted examining the&#xD;
      association of ADMA with obstructive lung diseases. Earlier the association of ADMA with the&#xD;
      development of obstructive lung diseases, airway resistance and indicators of the function of&#xD;
      external respiration in patients with obstructive lung diseases was shown.&#xD;
&#xD;
      Thus, there are prerequisites for studying the components of the nitric oxide system, such as&#xD;
      metabolites of nitric oxide, L-arginine, arginase, and asymmetric dimethylarginine, as a&#xD;
      biomarker of obstructive lung diseases. Based on this, it is planned to study of nitric oxide&#xD;
      metabolites (nitrates and nitrites), L-arginine, arginase-1, and asymmetric dimethylarginine&#xD;
      in patients with bronchial asthma and chronic obstructive pulmonary disease, followed by&#xD;
      observation to assess the prognosis of the disease.&#xD;
&#xD;
      The study is aimed at studying the clinical value of the nitric oxide synthesis modulators&#xD;
      (L-arginine, arginase-1 and asymmetric dimethylarginine) in patients with bronchial asthma&#xD;
      and chronic obstructive pulmonary disease, as well as assessing their effect on the prognosis&#xD;
      and the course of diseases .&#xD;
&#xD;
      The study objectives is&#xD;
&#xD;
        1. To assess the levels of modulators of the synthesis of nitric oxide (L-arginine,&#xD;
           arginase-1 and asymmetric dimethylarginine) in the blood of patients with asthma and&#xD;
           chronic obstructive pulmonary disease and their relationship with the clinical course of&#xD;
           the disease.&#xD;
&#xD;
        2. To evaluate the clinical value of the ratio of the levels of modulators of the synthesis&#xD;
           of nitric oxide (L-arginine, arginase-1 and asymmetric dimethylarginine) and the level&#xD;
           of metabolites of nitric oxide (nitrates and nitrites) in patients with bronchial asthma&#xD;
           and chronic obstructive pulmonary disease.&#xD;
&#xD;
        3. To assess the possibility of using the determination of the levels of modulators of&#xD;
           nitric oxide synthesis to predict the course of obstructive lung diseases and prevent&#xD;
           the development of exacerbations of bronchial asthma and chronic obstructive pulmonary&#xD;
           disease.&#xD;
&#xD;
        4. To assess the possibility of developing personalized treatment regimens for obstructive&#xD;
           lung diseases, based on the assesment of the levels of modulators of the synthesis of&#xD;
           nitric oxide (L-arginine, arginase-1 and asymmetric dimethylarginine) in the blood of&#xD;
           patients with asthma and chronic obstructive pulmonary disease.&#xD;
&#xD;
      It is planned to conduct a prospective case-control study in the three study groups. To all&#xD;
      patients will be performed: general clinical examination; Test of Adherence to Inhalers;&#xD;
      clinical and biochemical analysis of the blood; spirometry; assesment of the level of nitric&#xD;
      oxide metabolites in serum using the photocolorimetric method in Griss reaction; assesment of&#xD;
      the level of L-arginine, arginase-1 and asymmetric dimethylarginine in serum by enzyme&#xD;
      immunoassay using the laboratory kit Immundiagnostik (Germany). At the second phase of the&#xD;
      study, lasting 2 years, the prognostic capabilities of assesment the levels of modulators of&#xD;
      nitric oxide synthesis will be evaluated using a combined endpoint, included increase in&#xD;
      level of basis therapy, exacerbation, hospitalisation and mors associated with Asthma and&#xD;
      COPD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2021</start_date>
  <completion_date type="Anticipated">June 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Combined outcome - clinical worsening</measure>
    <time_frame>2 years</time_frame>
    <description>Combined outcome including increase in level of basis therapy, exacerbation, hospitalisation and mors associated with Asthma and COPD</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>NO-metabolites</measure>
    <time_frame>At initial visit</time_frame>
    <description>Serum level of total nitric oxide metabolites (nitrites and nitrates summary)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>L-arginine</measure>
    <time_frame>At initial visit</time_frame>
    <description>Serum level of L-arginine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arginase-1</measure>
    <time_frame>At initial visit</time_frame>
    <description>Serum level of arginase-1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ADMA</measure>
    <time_frame>At initial visit</time_frame>
    <description>Serum level of asymmetric dimethylarginine</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Asthma</condition>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>Asthma</arm_group_label>
    <description>Patients with Asthma</description>
  </arm_group>
  <arm_group>
    <arm_group_label>COPD</arm_group_label>
    <description>Patients with COPD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Healthy volunteers</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      venous blood sample&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Asthma and COPD patients from Ryazan region which admitted in clinics of the Ryazan State&#xD;
        Medical University&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  men and women aged between 18 and 70 years&#xD;
&#xD;
          -  a diagnosis of asthma or chronic obstructive pulmonary disease according to actual&#xD;
             GINA and GOLD guidelines&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  decompensated pathology of the cardiovascular system;&#xD;
&#xD;
          -  history of liver dysfunction accompanied by an increase in ALT, AST or total bilirubin&#xD;
             more than 3 times higher than the upper limit of normal;&#xD;
&#xD;
          -  history of severe renal impairment, accompanied by a decrease in glomerular filtration&#xD;
             rate below 60 ml/min (according to CKD-EPI);&#xD;
&#xD;
          -  abuse on psychoactive substances and / or alcohol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anton Shakhanov, MD, Cand.Sci. (Med.)</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ryazan State Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anton Shakhanov, MD, Cand.Sci. (Med.)</last_name>
    <phone>+7 910 635-95-75</phone>
    <email>shakhanovav@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Therapy</name>
      <address>
        <city>Ryazan'</city>
        <state>Ryazanskaya Obl.</state>
        <zip>390026</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anton Shakhanov, MD, PhD</last_name>
      <phone>+79106359575</phone>
    </contact>
    <contact_backup>
      <last_name>Zharkyniai Kanatbekova, MD</last_name>
    </contact_backup>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 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 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>nitric oxide, arginine, arginase</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</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/NCT04456491
org study id: ASCONO
nct id: NCT04456491
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It is planned to conduct a study of nitric oxide metabolites (nitrates and nitrites),
      L-arginine, arginase-1, and asymmetric dimethylarginine in patients with bronchial asthma and
      chronic obstructive pulmonary disease, followed by observation to assess the prognosis of the
      disease.
Chronic obstructive pulmonary disease and bronchial asthma have a leading position among
      respiratory diseases. A significant contribution to the clinical picture and long-term
      prognosis is made by exacerbations of COPD, which makes it relevant to search for methods for
      their prediction and prevention. According to the global initiative on bronchial asthma
      (GINA), bronchial asthma is characterized by high heterogeneity and the existence of many
      phenotypes and endotypes, which makes it relevant to use personalized medicine methods in
      patient management and, in particularly, the search for new biomarkers of asthma. Currently,
      in clinical practice, some biomarkers of obstructive lung diseases are widely used. Among
      them there are the level of eosinophils in the blood and sputum, the level of immunoglobulin
      E and the exhaled fraction of nitric oxide (FeNO). Obstructive lung diseases are
      characterized by persistent inflammation in the airways, which is accompanied by the
      manifestation of elements of systemic inflammation and endothelial dysfunction, which is
      associated with an altered release of vasoactive mediators, one of them is nitric oxide (NO).
      NO is a powerful vasodilator that is synthesized from L-arginine using the enzyme NO synthase
      (NOS). The NO molecule has small lifetime from 3 to 30 s, that's why the search for
      biomarkers with a more stable lifetime is relevant. Some of them it's nitric oxide
      metabolites, such as nitrates (NO3-), nitrites (NO2-), S-nitrosothiols, 3-nitrotyrosine.
      Nitrates and nitrites, which are metabolites of nitric oxide, may be of interest as one of
      the promising biochemical markers reflecting NO metabolism in the human body. Earlier in our
      study, the relationship between the plasma level of nitric oxide metabolites and the severity
      of bronchial asthma was shown, which may be a prerequisite for further study of the
      components of the nitric oxide system as potential biomarkers of bronchial obstructive
      diseases.

      A promising direction in the search for biomarkers related to the nitric oxide system is the
      study of L-arginine, which acts as a substrate in the reaction of NO formation. The
      bioavailability of L-arginine for NO synthases determines the activity of formation of nitric
      oxide in the respiratory tract, as evidenced by the effect of inhaled L-arginine on the level
      of exhaled fraction of nitric oxide. Earlier, in a US study, 26 patients with bronchial
      asthma showed a significant decrease in plasma L-arginine levels compared with healthy
      volunteers, and laboratory animal models showed that a decrease in L-arginine levels leads to
      airway hyperreactivity. Currently, a number of pilot clinical interventional studies have
      been carried out in which the administration of L-arginine improved the manifestations of
      bronchial asthma in some patients, but did not change the frequency of exacerbations in the
      total sample of patients. This indicates the possible existence of an endotype of bronchial
      asthma associated with impaired functioning of the nitric oxide system, and makes it
      promising to study the level of L-arginine in the blood as a potential biomarker of
      obstructive lung diseases.

      In addition to studying nitric oxide metabolites, substances that affect the formation of NO
      should be considered as potential biomarkers of the disease. One such substance is arginase,
      under the influence of which L-arginine is converted into L-ornithine and urea. In humans,
      two isoenzymes of arginase, arginase 1 and arginase 2, have been identified, which differ in
      cellular location and tissue distribution. Both arginase enzymes are expressed in the airways
      and can be found in endothelial and epithelial cells, fibroblasts, macrophages, and smooth
      muscle cells of the respiratory tract. Further metabolism of L-ornithine leads to the
      formation of polyamines and L-proline, which are involved in cell proliferation and
      differentiation, as well as in the production of collagen. Scientists have shown that
      increased arginase activity in the airways contributes to airway obstruction and
      hyperreactivity by decreasing the availability substrate for NOS. As a result, the production
      of NO decreases and superoxides form, which react with NO to form peroxynitrite, thereby
      increasing airway contractility and inflammation. In addition, increased airway arginase
      activity leads to an increase in L-ornithine production, which potentially contributes to
      airway remodeling due to stimulation of cell proliferation and collagen formation.

      The metabolism of L-arginine depends not only on arginase, but also on the methyltransferase
      enzyme, which methylates L-arginine residues, which undergo proteolysis with the formation of
      asymmetric and symmetric dimethylarginine (ADMA and SDMA). These amino acids inhibit NOS
      activity, since ADMA is a competitive inhibitor of the enzyme, while SDMA is a competitor to
      L-arginine transport. Serum ADMA and SDMA, as well as L-arginine concentrations increase with
      COPD and increase further with the development of exacerbation. It is important to note that
      the concentration of ADMA in blood serum is probably an independent risk factor for long-term
      mortality from all causes in obstructive lung diseases and is associated with increased
      airway resistance. In recent years, several studies have been conducted examining the
      association of ADMA with obstructive lung diseases. Earlier the association of ADMA with the
      development of obstructive lung diseases, airway resistance and indicators of the function of
      external respiration in patients with obstructive lung diseases was shown.

      Thus, there are prerequisites for studying the components of the nitric oxide system, such as
      metabolites of nitric oxide, L-arginine, arginase, and asymmetric dimethylarginine, as a
      biomarker of obstructive lung diseases. Based on this, it is planned to study of nitric oxide
      metabolites (nitrates and nitrites), L-arginine, arginase-1, and asymmetric dimethylarginine
      in patients with bronchial asthma and chronic obstructive pulmonary disease, followed by
      observation to assess the prognosis of the disease.

      The study is aimed at studying the clinical value of the nitric oxide synthesis modulators
      (L-arginine, arginase-1 and asymmetric dimethylarginine) in patients with bronchial asthma
      and chronic obstructive pulmonary disease, as well as assessing their effect on the prognosis
      and the course of diseases .

      The study objectives is

        1. To assess the levels of modulators of the synthesis of nitric oxide (L-arginine,
           arginase-1 and asymmetric dimethylarginine) in the blood of patients with asthma and
           chronic obstructive pulmonary disease and their relationship with the clinical course of
           the disease.

        2. To evaluate the clinical value of the ratio of the levels of modulators of the synthesis
           of nitric oxide (L-arginine, arginase-1 and asymmetric dimethylarginine) and the level
           of metabolites of nitric oxide (nitrates and nitrites) in patients with bronchial asthma
           and chronic obstructive pulmonary disease.

        3. To assess the possibility of using the determination of the levels of modulators of
           nitric oxide synthesis to predict the course of obstructive lung diseases and prevent
           the development of exacerbations of bronchial asthma and chronic obstructive pulmonary
           disease.

        4. To assess the possibility of developing personalized treatment regimens for obstructive
           lung diseases, based on the assesment of the levels of modulators of the synthesis of
           nitric oxide (L-arginine, arginase-1 and asymmetric dimethylarginine) in the blood of
           patients with asthma and chronic obstructive pulmonary disease.

      It is planned to conduct a prospective case-control study in the three study groups. To all
      patients will be performed: general clinical examination; Test of Adherence to Inhalers;
      clinical and biochemical analysis of the blood; spirometry; assesment of the level of nitric
      oxide metabolites in serum using the photocolorimetric method in Griss reaction; assesment of
      the level of L-arginine, arginase-1 and asymmetric dimethylarginine in serum by enzyme
      immunoassay using the laboratory kit Immundiagnostik (Germany). At the second phase of the
      study, lasting 2 years, the prognostic capabilities of assesment the levels of modulators of
      nitric oxide synthesis will be evaluated using a combined endpoint, included increase in
      level of basis therapy, exacerbation, hospitalisation and mors associated with Asthma and
      COPD.
observational model: Case-Control
time perspective: Prospective
measure: Combined outcome - clinical worsening
time frame: 2 years
description: Combined outcome including increase in level of basis therapy, exacerbation, hospitalisation and mors associated with Asthma and COPD
measure: NO-metabolites
time frame: At initial visit
description: Serum level of total nitric oxide metabolites (nitrites and nitrates summary)
measure: L-arginine
time frame: At initial visit
description: Serum level of L-arginine
measure: Arginase-1
time frame: At initial visit
description: Serum level of arginase-1
measure: ADMA
time frame: At initial visit
description: Serum level of asymmetric dimethylarginine
arm group label: Asthma
description: Patients with Asthma
arm group label: COPD
description: Patients with COPD
arm group label: Control group
description: Healthy volunteers
venous blood sample
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Anton Shakhanov, MD, Cand.Sci. (Med.)
role: Principal Investigator
affiliation: Ryazan State Medical University
last name: Anton Shakhanov, MD, Cand.Sci. (Med.)
phone: +7 910 635-95-75
email: shakhanovav@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Russian Federation
responsible party type: Sponsor
mesh term: Asthma
sharing ipd: No