xml: <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/NCT05975788</url>
    </required_header>
    <id_info>
      <org_study_id>YL20230221</org_study_id>
      <nct_id>NCT05975788</nct_id>
    </id_info>
    <brief_title>Effect of Staphylococcus and Neisseria Tablets on Patients With Chronic Obstructive Pulmonary Disease</brief_title>
    <official_title>Effect of Staphylococcus and Neisseria Tablets on Clinical Outcome Among Patients With Chronic Obstructive Pulmonary Disease: A Multi-center, Prospective Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking University Third Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking University Third Hospital</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>
        This is a multi-center, prospective study. This study aims to investigate the incidence of&#xD;
        acute exacerbation within 12 months, as well as the safety of Staphylococcus and Neisseria&#xD;
        Tablets on patients with chronic obstructive pulmonary disease (COPD). In addition, this&#xD;
        study investigates the improvement of hospitalization, improvement of pulmonary function,&#xD;
        improvement of symptoms, and the use of anti-Infective drugs among COPD patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A total of 750 eligible COPD patients were enrolled, and were randomly divided into&#xD;
        experimental group and control group with a ratio of 2:1. Experimental group will receive&#xD;
        Staphylococcus and Neisseria Tablets (0.3mg/tablet) and standard care. Drug administration is&#xD;
        4 tablets each time and 3 times a day, and treatment period ranges from 3 to 6 months.&#xD;
        Control group will receive standard care without interventions.&#xD;
  &#xD;
        All participants have to sign informed consent. After baseline (V0/V1), participants will be&#xD;
        followed up for 12 months with four follow-up visits at 4 weeks ± 14d (V2), 13 weeks ± 14d&#xD;
        (V3), 26 weeks ± 14d (V4), and 52 weeks ± 14d (V5). Among them, V2 can be phone interview.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">July 2025</completion_date>
    <primary_completion_date type="Anticipated">February 2025</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>AECOPD (Acute exacerbation COPD)</measure>
      <time_frame>12 months</time_frame>
      <description>Incidence of AECOPD within 12 months. Diagnosis of AECOPD is based on the Chinese Expert Consensus on Diagnosis and Management of AECOPD (2023 version).&#xD;
  Mild：No respiratory failure. Respiratory rate 20-30 times/min; no use of ventilator or change in mental state; fraction of inspiration O2 (FiO2) improves after supplemental oxygen; no increase in partial pressure of CO2 in artery (PaCO2).&#xD;
  Moderate：Acute respiratory failure but not life threatening. Respiratory rate &gt; 30 times/min; use of ventilator or change in mental state; FiO2&gt;35% after supplemental oxygen, improved hypoxemia; hypercapnia, PaCO2 increases from baseline or increases to 50-60mmHg.&#xD;
  Severe：Acute respiratory failure and life threatening. Respiratory rate &gt; 30 times/min; use of ventilator; acute changes in mental state; FiO2&gt;45% after supplemental oxygen, no improvement in hypoxemia; PaCO2 increases by &gt; 60mmHg from baseline or acidosis.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Moderate or severe AECOPD</measure>
      <time_frame>12 months</time_frame>
      <description>Incidence of moderate or severe AECOPD within 12 months. Diagnosis of AECOPD is based on the Chinese Expert Consensus on Diagnosis and Management of AECOPD (2023 version).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in frequency of AECOPD</measure>
      <time_frame>12 months</time_frame>
      <description>Change in frequency of AECOPD within 12 months. Diagnosis of AECOPD is based on the Chinese Expert Consensus on Diagnosis and Management of AECOPD (2023 version).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hospitalization due to severe AECOPD</measure>
      <time_frame>12 months</time_frame>
      <description>Hospitalization due to severe AECOPD within 12 months. Diagnosis of AECOPD is based on the Chinese Expert Consensus on Diagnosis and Management of AECOPD (2023 version). Hospitalization include ICU admission.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>mMRC（modified Medical Research Council）</measure>
      <time_frame>1 month, 3 months, 6 months, and 12 months</time_frame>
      <description>Changes in mMRC during the observation period. mMRC score a 5-point (0-4) scale, and higher grades indicate higher severity of dyspnea.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CAT（COPD Assessment Test）</measure>
      <time_frame>1 month, 3 months, 6 months, and 12 months</time_frame>
      <description>Changes in CAT during the observation period. CAT score ranges from 0 to 40 points, and higher scores indicate higher symptom burden of COPD on patients.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>TDI（Transition Dyspnea Index）</measure>
      <time_frame>1 month, 3 months, 6 months, and 12 months</time_frame>
      <description>Changes in TDI during the observation period. TDI score ranges from -9 to 9 points, and higher scores indicate more significant improvements from baseline.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CET（Cough Evaluation Test）</measure>
      <time_frame>1 month, 3 months, 6 months, and 12 months</time_frame>
      <description>Changes in CET during the observation period. CET score ranges from 5 to 25 points, and higher scores indicate higher cough severity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cough severity VAS（Visual Analog Scale）</measure>
      <time_frame>1 month, 3 months, 6 months, and 12 months</time_frame>
      <description>Changes in VAS during the observation period. VAS a 100-mm linear scale ranging from &quot;no cough&quot; (0 mm) to &quot;worst cough&quot; (100 mm), and higher scores indicate higher cough severity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in the use of inhaled drugs</measure>
      <time_frame>1 month, 3 months, 6 months, and 12 months</time_frame>
      <description>According to the medication administration record, any changes in the use of inhaled drugs during the observation period, including dosage, frequency, duration, etc.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pulmonary function</measure>
      <time_frame>6 months, and 12 months</time_frame>
      <description>Changes in pulmonary function during the observation period. Pulmonary function is evaluated by the ratio of forced expiratory volume in the first second (FEV1) to forced vital capacity (FVC) (FEV1/FVC)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in the use of anti-infective drugs</measure>
      <time_frame>12 months</time_frame>
      <description>According to the medication administration record, any changes in the use of ianti-infective drugs within 12 months, including dosage, frequency, duration, etc.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse events</measure>
      <time_frame>12 months</time_frame>
      <description>Occurrence of any Staphylococcus and Neisseria related adverse events during the study period.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">750</enrollment>
    <condition>Chronic Obstructive Pulmonary Disease</condition>
    <arm_group>
      <arm_group_label>Staphylococcus and Neisseria group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Experimental group will receive Staphylococcus and Neisseria Tablets (0.3mg/tablet) and standard care. Administration Staphylococcus and Neisseria is 4 tablets each time and 3 times a day, and treatment period ranges from 3 to 6 months.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard care group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Standard care based on clinical experience without interventions.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Staphylococcus and Neisseria Tablets</intervention_name>
      <description>Staphylococcus and Neisseria tablets is used as an adjuvant treatment drug for respiratory disease in acute attack period, such as chronic tracheitis, bronchitis and various types of colds. It has been proved to effectively shorten the course of disease. In this study, Staphylococcus and Neisseria tablets will be administered with 4 tablets each time and 3 times a day, and treatment period ranges from 3 to 6 months according to clinicians.</description>
      <arm_group_label>Staphylococcus and Neisseria group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18-80 years, males and females.&#xD;
  &#xD;
            -  Clinical diagnosis of COPD, defined as FEV1/FVC&lt;70% after inhaling bronchodilators.&#xD;
  &#xD;
            -  At least 1 moderate to severe acute exacerbation of COPD in the past year.&#xD;
  &#xD;
            -  Patient or their legal agent sign informed consent with a date after understanding the&#xD;
               purpose and procedures of the research, and be willing to participate in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with active pulmonary tuberculosis, asthma, or uncontrolled advanced&#xD;
               malignant tumors; or after partial, lobar, or total pneumonectomy.&#xD;
  &#xD;
            -  Patients with acute cardio cerebral vascular disease such as acute myocardial&#xD;
               infarction, acute stroke and acute heart failure.&#xD;
  &#xD;
            -  Patients with liver failure or renal failure and need blood purification treatment.&#xD;
  &#xD;
            -  Patients with rheumatic diseases and autoimmune diseases.&#xD;
  &#xD;
            -  Have participated or currently in interventional clinical trials within 30 days.&#xD;
  &#xD;
            -  Patients with previous (within 3 months before signing the informed consent) or&#xD;
               current use of immunomodulatory drugs (including thymosin, thymosin, interferon,&#xD;
               transfer factor, BCG vaccine polysaccharide, and any kind of bacterial extract such as&#xD;
               Biostim, pneumonia vaccine, and influenza vaccine).&#xD;
  &#xD;
            -  Currently pregnant or breast-feeding women, or those who have fertility but cannot&#xD;
               take contraceptive measures during the study period.&#xD;
  &#xD;
            -  Other conditions that are not suitable for the trials according to investigator's&#xD;
               judgement.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yongchang Sun, M.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Peking University Third Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yongchang Sun, M.D.</last_name>
      <phone>86-15611963697</phone>
      <email>suny@bjmu.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Peking University Third Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100191</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Peking University Third Hospital</investigator_affiliation>
      <investigator_full_name>Sun Yongchang</investigator_full_name>
      <investigator_title>Director of Respiratory Department</investigator_title>
    </responsible_party>
    <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>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05975788
  org study id: YL20230221
  nct id: NCT05975788
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a multi-center, prospective study. This study aims to investigate the incidence of
        acute exacerbation within 12 months, as well as the safety of Staphylococcus and Neisseria
        Tablets on patients with chronic obstructive pulmonary disease (COPD). In addition, this
        study investigates the improvement of hospitalization, improvement of pulmonary function,
        improvement of symptoms, and the use of anti-Infective drugs among COPD patients.
  A total of 750 eligible COPD patients were enrolled, and were randomly divided into
        experimental group and control group with a ratio of 2:1. Experimental group will receive
        Staphylococcus and Neisseria Tablets (0.3mg/tablet) and standard care. Drug administration is
        4 tablets each time and 3 times a day, and treatment period ranges from 3 to 6 months.
        Control group will receive standard care without interventions.
  
        All participants have to sign informed consent. After baseline (V0/V1), participants will be
        followed up for 12 months with four follow-up visits at 4 weeks ± 14d (V2), 13 weeks ± 14d
        (V3), 26 weeks ± 14d (V4), and 52 weeks ± 14d (V5). Among them, V2 can be phone interview.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: AECOPD (Acute exacerbation COPD)
  time frame: 12 months
  description: Incidence of AECOPD within 12 months. Diagnosis of AECOPD is based on the Chinese Expert Consensus on Diagnosis and Management of AECOPD (2023 version).
  Mild：No respiratory failure. Respiratory rate 20-30 times/min; no use of ventilator or change in mental state; fraction of inspiration O2 (FiO2) improves after supplemental oxygen; no increase in partial pressure of CO2 in artery (PaCO2).
  Moderate：Acute respiratory failure but not life threatening. Respiratory rate > 30 times/min; use of ventilator or change in mental state; FiO2>35% after supplemental oxygen, improved hypoxemia; hypercapnia, PaCO2 increases from baseline or increases to 50-60mmHg.
  Severe：Acute respiratory failure and life threatening. Respiratory rate > 30 times/min; use of ventilator; acute changes in mental state; FiO2>45% after supplemental oxygen, no improvement in hypoxemia; PaCO2 increases by > 60mmHg from baseline or acidosis.
  measure: Moderate or severe AECOPD
  time frame: 12 months
  description: Incidence of moderate or severe AECOPD within 12 months. Diagnosis of AECOPD is based on the Chinese Expert Consensus on Diagnosis and Management of AECOPD (2023 version).
  measure: Change in frequency of AECOPD
  time frame: 12 months
  description: Change in frequency of AECOPD within 12 months. Diagnosis of AECOPD is based on the Chinese Expert Consensus on Diagnosis and Management of AECOPD (2023 version).
  measure: Hospitalization due to severe AECOPD
  time frame: 12 months
  description: Hospitalization due to severe AECOPD within 12 months. Diagnosis of AECOPD is based on the Chinese Expert Consensus on Diagnosis and Management of AECOPD (2023 version). Hospitalization include ICU admission.
  measure: mMRC（modified Medical Research Council）
  time frame: 1 month, 3 months, 6 months, and 12 months
  description: Changes in mMRC during the observation period. mMRC score a 5-point (0-4) scale, and higher grades indicate higher severity of dyspnea.
  measure: CAT（COPD Assessment Test）
  time frame: 1 month, 3 months, 6 months, and 12 months
  description: Changes in CAT during the observation period. CAT score ranges from 0 to 40 points, and higher scores indicate higher symptom burden of COPD on patients.
  measure: TDI（Transition Dyspnea Index）
  time frame: 1 month, 3 months, 6 months, and 12 months
  description: Changes in TDI during the observation period. TDI score ranges from -9 to 9 points, and higher scores indicate more significant improvements from baseline.
  measure: CET（Cough Evaluation Test）
  time frame: 1 month, 3 months, 6 months, and 12 months
  description: Changes in CET during the observation period. CET score ranges from 5 to 25 points, and higher scores indicate higher cough severity.
  measure: Cough severity VAS（Visual Analog Scale）
  time frame: 1 month, 3 months, 6 months, and 12 months
  description: Changes in VAS during the observation period. VAS a 100-mm linear scale ranging from "no cough" (0 mm) to "worst cough" (100 mm), and higher scores indicate higher cough severity.
  measure: Changes in the use of inhaled drugs
  time frame: 1 month, 3 months, 6 months, and 12 months
  description: According to the medication administration record, any changes in the use of inhaled drugs during the observation period, including dosage, frequency, duration, etc.
  measure: Pulmonary function
  time frame: 6 months, and 12 months
  description: Changes in pulmonary function during the observation period. Pulmonary function is evaluated by the ratio of forced expiratory volume in the first second (FEV1) to forced vital capacity (FVC) (FEV1/FVC)
  measure: Changes in the use of anti-infective drugs
  time frame: 12 months
  description: According to the medication administration record, any changes in the use of ianti-infective drugs within 12 months, including dosage, frequency, duration, etc.
  measure: Adverse events
  time frame: 12 months
  description: Occurrence of any Staphylococcus and Neisseria related adverse events during the study period.
  arm group label: Staphylococcus and Neisseria group
  arm group type: Experimental
  description: Experimental group will receive Staphylococcus and Neisseria Tablets (0.3mg/tablet) and standard care. Administration Staphylococcus and Neisseria is 4 tablets each time and 3 times a day, and treatment period ranges from 3 to 6 months.
  arm group label: Standard care group
  arm group type: No Intervention
  description: Standard care based on clinical experience without interventions.
  intervention type: Drug
  intervention name: Staphylococcus and Neisseria Tablets
  description: Staphylococcus and Neisseria tablets is used as an adjuvant treatment drug for respiratory disease in acute attack period, such as chronic tracheitis, bronchitis and various types of colds. It has been proved to effectively shorten the course of disease. In this study, Staphylococcus and Neisseria tablets will be administered with 4 tablets each time and 3 times a day, and treatment period ranges from 3 to 6 months according to clinicians.
  arm group label: Staphylococcus and Neisseria group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Yongchang Sun, M.D.
  role: Principal Investigator
  affiliation: Peking University Third Hospital
  last name: Yongchang Sun, M.D.
  phone: 86-15611963697
  email: suny@bjmu.edu.cn
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Peking University Third Hospital
  investigator full name: Sun Yongchang
  investigator title: Director of Respiratory Department
  mesh term: Lung Diseases
  mesh term: Lung Diseases, Obstructive
  mesh term: Pulmonary Disease, Chronic Obstructive