<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/NCT02248909</url>
  </required_header>
  <id_info>
    <org_study_id>NIS-RRU-XXX-2014/2</org_study_id>
    <nct_id>NCT02248909</nct_id>
  </id_info>
  <brief_title>Non-interventional Study of Spirometry Use to Diagnose COPD (Chronic Obstructive Pulmonary Disease) and to Prescribe Treatment to COPD Patients in the Outpatient Institutions</brief_title>
  <acronym>SUPPORT</acronym>
  <official_title>Non-interventional Multicenter Study of Spirometry Use to Diagnose COPD and to Prescribe Treatment to COPD Patients in the Outpatient Institutions of the healthcaRe System of the Russian FederaTion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is an observational multicenter descriptive study. The study will be conducted in&#xD;
      primary outpatient medical institutions in different cities of the RF. Primary care doctors&#xD;
      who are primary contact for greater part of the population in RF including COPD patients will&#xD;
      be invited as investigators. This observational descriptive study will be conducted within&#xD;
      the routine practice of outpatient institutions. Since spirometry is not an integral part of&#xD;
      the current all-round clinical practice, only those sites where spirometry test is routinely&#xD;
      used in examination of patients with COPD risk factors and when monitoring condition of COPD&#xD;
      patients will take part in the study. Thus the decision about spirometry in every study&#xD;
      subject will be determined only by the existing treatment approaches.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is an observational multicenter descriptive study. No hypothesis is checked in the&#xD;
      study.&#xD;
&#xD;
      3000 patients with COPD risk factors are planned to be enrolled into the study (current&#xD;
      smokers and former smokers with smoking history of ≥10 pack/years at the age of &gt;40 years who&#xD;
      have respiratory complaints) and 1450 patients previously diagnosed with COPD who contacted&#xD;
      the physicians of outpatient institutions during the study (for 3 months) and are currently&#xD;
      in remission.&#xD;
&#xD;
      100 patients with COPD risk factors and approximately 50 patients early diagnosed with COPD&#xD;
      currently being stable are planned to be enrolled in each site.&#xD;
&#xD;
      Physicians and pulmonologists of the outpatient institutions of the Russian Federation will&#xD;
      take part in the study in about 30 sites in 18 cities (a total of 31% of RF population live&#xD;
      in the cities).&#xD;
&#xD;
      The observational descriptive study will be conducted within the routine practice of&#xD;
      outpatient institutions. Examining and treatment of patients will be performed according to&#xD;
      the rules of the routine practice.&#xD;
&#xD;
      Patients will be enrolled into the study as they visit the outpatient institutions for the&#xD;
      medical care. The study does not imply any special invitation of COPD patients to the sites&#xD;
      for them to be enrolled into the study. Therefore the conditions are made for the study&#xD;
      population to reflect the typical visitors of the primary care medical institutions in&#xD;
      different RF (Russian Federation) regions. Patients are enrolled into the study regardless&#xD;
      the reason for appointment with a doctor. A reason for the appointment can be respiratory&#xD;
      complaints as well as any other diseases or certificates and conclusions. To be enrolled into&#xD;
      the study the subjects must sign the written Informed Consent Form (ICF) to participate in&#xD;
      the study and to use personal data confidentially.&#xD;
&#xD;
      To investigate the role of spirometry in diagnostics and management of the COPD patients, two&#xD;
      groups of patients are supposed to be included into the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The number of COPD cases first-time identified by the spirometry in relation to the total number of patients who visited the outpatient institutions of the RF during the study</measure>
    <time_frame>Up to 5 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of prescriptions for patients with COPD that correspond to the severity of the condition of the patients according to GOLD classification and GOLD recommendations for the treatment choice</measure>
    <time_frame>Up to 5 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Distribution (%) of patients with COPD who contacted the primary care doctors during the study based on bronchial obstruction severity (GOLD 1-4) and classes according to GOLD classification (2014)</measure>
    <time_frame>Up to 5 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The percentage (%) of patients who contact the medical institutions of RF daily can be referred to the group with risk of COPD development</measure>
    <time_frame>Up to 5 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score on SGRQ at 1st Visit in COPD patients receiving monotherapy with inhaled long-acting and super long-acting bronchodilators and in patients who are treated with combined drugs containing inhaled corticosteroids and long-acting β2 agonists</measure>
    <time_frame>Up to 5 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score on САТ at 1st Visit in COPD patients receiving monotherapy with inhaled long-acting and super long-acting bronchodilators and in patients who are treated with combined drugs containing inhaled corticosteroids and long-acting β2 agonists</measure>
    <time_frame>Up to 5 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean number of puffs of SABA for 24h in COPD patients receiving monotherapy with inhaled long-acting and super long-acting bronchodilators and in patients treated with combined drugs (inhaled corticosteroids and long-acting β2 agonists)</measure>
    <time_frame>Upto 5 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The percentage of COPD patients in the routine practice of these medical institutions</measure>
    <time_frame>Up to 5 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related economic losses calculated on the basis of the collected data (number of hospitalizations due to COPD exacerbations, calls of emergency service due to COPD, seeking outpatient care due to COPD) for the previous year</measure>
    <time_frame>Up to 5 months</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">4232</enrollment>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>Patients with COPD risk factors</arm_group_label>
    <description>Group of subjects with COPD risk factors. This group will include patients aged ≥40 years, with smoking history of ≥10 pack years and long-active (not less than 3 consequent months) respiratory complaints</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients previously diagnosed with COPD</arm_group_label>
    <description>Group of patients who according to the medical records have already been diagnosed with COPD</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with COPD risk factors and patients with previously diagnosed COPD who have been&#xD;
        observed in outpatient medical institutions of the RF are planned to be enrolled into the&#xD;
        study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Patients with COPD risk factors must meet all the following inclusion criteria:&#xD;
&#xD;
          1. Age ≥ 40 years.&#xD;
&#xD;
          2. Smoker or former smoker with smoking history of ≥ 10 pack years (patient is considered&#xD;
             to be a former smoker in case of smoking cessation for ≥6 months) (the patient smokes&#xD;
             or smoked before but then gave up smoking. The obligatory condition: smoking history&#xD;
             is ≥10 pack years. It means that the patient smoked a pack per day for 10 years or&#xD;
             half a pack for 20 years or 2 packs a day for 5 years).&#xD;
&#xD;
          3. Any complaints judged by the investigator to be possibly related to the respiratory&#xD;
             diseases (chronic cough, dyspnea, cough with sputum, feeling of stiffness in the&#xD;
             chest) or the evidence of the chronic respiratory diseases (chronic bronchitis in&#xD;
             remission, pneumosclerosis) in the medical chart.&#xD;
&#xD;
          4. The patient is expected to have the spirometry test performed in accordance with the&#xD;
             current medical practice before inviting him to the study.&#xD;
&#xD;
          5. Patients considered by the investigator to be able to complete themselves&#xD;
             questionnaires used in the current study.&#xD;
&#xD;
          6. Signed Patient's Information Sheet and Informed Consent Form.&#xD;
&#xD;
        Patients with previously diagnosed COPD must meet all the following inclusion criteria:&#xD;
&#xD;
          1. Male and female of any age who were diagnosed with COPD before the study starts.&#xD;
&#xD;
          2. Patients whose COPD was not the direct reason for visiting the doctor or COPD patients&#xD;
             who have COPD symptoms or signs requiring diagnostic or therapy.&#xD;
&#xD;
          3. Patients judged by the investigator as being capable to complete themselves the&#xD;
             questionnaires used in the current study&#xD;
&#xD;
          4. Patient was scheduled to have the spirometry test performed in accordance with the&#xD;
             existing medical practice before inviting him/her into the study&#xD;
&#xD;
          5. Signed Patient's Information Sheet and Informed Consent Form.&#xD;
&#xD;
        Exclusion criteria for patients with COPD risk factors:&#xD;
&#xD;
          1. Previously diagnosed chronic obstructive pulmonary disease.&#xD;
&#xD;
          2. Patients diagnosed with asthma, pulmonary tuberculosis, congenital lung abnormality,&#xD;
             cystic fibrosis, lung cancer or cancer of the upper respiratory tract, patients who&#xD;
             had a lung resection in the past due to pulmonary tuberculosis and other lung surgery,&#xD;
             patients with stenosis of the upper respiratory tract, post-tracheotomy patients with&#xD;
             the developed fibrotic stenosis of the trachea or post-intubation trachea stenosis,&#xD;
             patients with ribs fractures of &lt;3 weeks, pneumo- and hydrothorax of any etiology.&#xD;
&#xD;
          3. Patients who have contraindications for performing spirometry tests, patients with&#xD;
             acute coronary syndrome or unstable circulatory dynamics. Patients who need emergency&#xD;
             medical care at the moment of the visit.&#xD;
&#xD;
          4. Participation in any interventional clinical trial within 3 months prior the&#xD;
             enrollment into the study and at the moment.&#xD;
&#xD;
        Patients with previously diagnosed COPD must meet all the following inclusion criteria:&#xD;
&#xD;
          1. Patients diagnosed with asthma, pulmonary tuberculosis, congenital lung abnormality,&#xD;
             cystic fibrosis, lung cancer or cancer of the upper respiratory tract, patients who&#xD;
             had a lung resection in the past due to pulmonary tuberculosis and other lung surgery,&#xD;
             patients with stenosis of the upper respiratory tract, post-tracheotomy patients with&#xD;
             fibrotic stenosis of the trachea or post-intubation trachea stenosis, patients with&#xD;
             rib fractures of &lt;3 weeks, pneumo- and hydrothorax of any etiology.&#xD;
&#xD;
          2. Active exacerbation of chronic obstructive pulmonary disease at the moment of&#xD;
             enrollment into the study.&#xD;
&#xD;
          3. Patients who have contraindications for performing spirometry tests, patients with&#xD;
             acute coronary syndrome or unstable hemodynamics. Patients who need emergency medical&#xD;
             care at the time of the visit.&#xD;
&#xD;
          4. Participation in any interventional clinical trial within 3 months prior the&#xD;
             enrollment into the study and at the moment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexander Bedenkov</last_name>
    <role>Study Director</role>
    <affiliation>AstraZeneca</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Vladimir Archipov, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>I.M. Sechenov First Moscow State Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Barnaul</city>
        <state>Nis-rru-xxx-2014/2</state>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Blagoveschensk</city>
        <state>Nis-rru-xxx-2014/2</state>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chelyabinsk</city>
        <state>Nis-rru-xxx-2014/2</state>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Cherepovets</city>
        <state>Nis-rru-xxx-2014/2</state>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Izhevsk</city>
        <state>Nis-rru-xxx-2014/2</state>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kazan</city>
        <state>Nis-rru-xxx-2014/2</state>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kemerovo</city>
        <state>Nis-rru-xxx-2014/2</state>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Krasnoyarsk</city>
        <state>Nis-rru-xxx-2014/2</state>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Moscow</city>
        <state>Nis-rru-xxx-2014/2</state>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Naberezhnye Chelny</city>
        <state>Nis-rru-xxx-2014/2</state>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Novosibirsk</city>
        <state>Nis-rru-xxx-2014/2</state>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Omsk</city>
        <state>Nis-rru-xxx-2014/2</state>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Petrozavodsk</city>
        <state>Nis-rru-xxx-2014/2</state>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ryazan</city>
        <state>Nis-rru-xxx-2014/2</state>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Smolensk</city>
        <state>Nis-rru-xxx-2014/2</state>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>St.Petersburg</city>
        <state>Nis-rru-xxx-2014/2</state>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tomsk</city>
        <state>Nis-rru-xxx-2014/2</state>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ulan-Ude</city>
        <state>Nis-rru-xxx-2014/2</state>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Vladivostok</city>
        <state>Nis-rru-xxx-2014/2</state>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Yakutsk</city>
        <state>Nis-rru-xxx-2014/2</state>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Yfa</city>
        <state>Nis-rru-xxx-2014/2</state>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Stavropol</city>
        <state>Nis-rru-xxx-2014/3</state>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <link>
    <url>http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&amp;studyid=3275&amp;filename=SUPPORT_REPORTSynopsis_2015-12-07.pdf</url>
    <description>CSR Synopsis</description>
  </link>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>September 19, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>March 31, 2016</last_update_submitted>
  <last_update_submitted_qc>March 31, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 1, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COPD, Primary Care, Spirometry, Risk factors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <!-- 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/NCT02248909
org study id: NIS-RRU-XXX-2014/2
nct id: NCT02248909
lead sponsor: 
has dmc: No
This study is an observational multicenter descriptive study. The study will be conducted in
      primary outpatient medical institutions in different cities of the RF. Primary care doctors
      who are primary contact for greater part of the population in RF including COPD patients will
      be invited as investigators. This observational descriptive study will be conducted within
      the routine practice of outpatient institutions. Since spirometry is not an integral part of
      the current all-round clinical practice, only those sites where spirometry test is routinely
      used in examination of patients with COPD risk factors and when monitoring condition of COPD
      patients will take part in the study. Thus the decision about spirometry in every study
      subject will be determined only by the existing treatment approaches.
The study is an observational multicenter descriptive study. No hypothesis is checked in the
      study.

      3000 patients with COPD risk factors are planned to be enrolled into the study (current
      smokers and former smokers with smoking history of ≥10 pack/years at the age of >40 years who
      have respiratory complaints) and 1450 patients previously diagnosed with COPD who contacted
      the physicians of outpatient institutions during the study (for 3 months) and are currently
      in remission.

      100 patients with COPD risk factors and approximately 50 patients early diagnosed with COPD
      currently being stable are planned to be enrolled in each site.

      Physicians and pulmonologists of the outpatient institutions of the Russian Federation will
      take part in the study in about 30 sites in 18 cities (a total of 31% of RF population live
      in the cities).

      The observational descriptive study will be conducted within the routine practice of
      outpatient institutions. Examining and treatment of patients will be performed according to
      the rules of the routine practice.

      Patients will be enrolled into the study as they visit the outpatient institutions for the
      medical care. The study does not imply any special invitation of COPD patients to the sites
      for them to be enrolled into the study. Therefore the conditions are made for the study
      population to reflect the typical visitors of the primary care medical institutions in
      different RF (Russian Federation) regions. Patients are enrolled into the study regardless
      the reason for appointment with a doctor. A reason for the appointment can be respiratory
      complaints as well as any other diseases or certificates and conclusions. To be enrolled into
      the study the subjects must sign the written Informed Consent Form (ICF) to participate in
      the study and to use personal data confidentially.

      To investigate the role of spirometry in diagnostics and management of the COPD patients, two
      groups of patients are supposed to be included into the study.
observational model: Cohort
time perspective: Prospective
measure: The number of COPD cases first-time identified by the spirometry in relation to the total number of patients who visited the outpatient institutions of the RF during the study
time frame: Up to 5 months
measure: Percentage of prescriptions for patients with COPD that correspond to the severity of the condition of the patients according to GOLD classification and GOLD recommendations for the treatment choice
time frame: Up to 5 months
measure: Distribution (%) of patients with COPD who contacted the primary care doctors during the study based on bronchial obstruction severity (GOLD 1-4) and classes according to GOLD classification (2014)
time frame: Up to 5 months
measure: The percentage (%) of patients who contact the medical institutions of RF daily can be referred to the group with risk of COPD development
time frame: Up to 5 months
measure: Score on SGRQ at 1st Visit in COPD patients receiving monotherapy with inhaled long-acting and super long-acting bronchodilators and in patients who are treated with combined drugs containing inhaled corticosteroids and long-acting β2 agonists
time frame: Up to 5 months
measure: Score on САТ at 1st Visit in COPD patients receiving monotherapy with inhaled long-acting and super long-acting bronchodilators and in patients who are treated with combined drugs containing inhaled corticosteroids and long-acting β2 agonists
time frame: Up to 5 months
measure: Mean number of puffs of SABA for 24h in COPD patients receiving monotherapy with inhaled long-acting and super long-acting bronchodilators and in patients treated with combined drugs (inhaled corticosteroids and long-acting β2 agonists)
time frame: Upto 5 months
measure: The percentage of COPD patients in the routine practice of these medical institutions
time frame: Up to 5 months
measure: Health-related economic losses calculated on the basis of the collected data (number of hospitalizations due to COPD exacerbations, calls of emergency service due to COPD, seeking outpatient care due to COPD) for the previous year
time frame: Up to 5 months
arm group label: Patients with COPD risk factors
description: Group of subjects with COPD risk factors. This group will include patients aged ≥40 years, with smoking history of ≥10 pack years and long-active (not less than 3 consequent months) respiratory complaints
arm group label: Patients previously diagnosed with COPD
description: Group of patients who according to the medical records have already been diagnosed with COPD
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Alexander Bedenkov
role: Study Director
affiliation: AstraZeneca
last name: Vladimir Archipov, Prof.
role: Principal Investigator
affiliation: I.M. Sechenov First Moscow State Medical University
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country: Russian Federation
url: http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3275&filename=SUPPORT_REPORTSynopsis_2015-12-07.pdf
description: CSR Synopsis
responsible party type: Sponsor
mesh term: Pulmonary Disease, Chronic Obstructive