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/NCT06038084</url>
    </required_header>
    <id_info>
      <org_study_id>HL-BRPS-501</org_study_id>
      <nct_id>NCT06038084</nct_id>
    </id_info>
    <brief_title>Evaluate the Efficacy and Safety of Acute Bronchitis Symptoms Improvement for Bronpass Tab. Compared to Erdos Capsule</brief_title>
    <official_title>A Prospective, Multi-center, Active-control, Parallel Group, Randomized, Double-blinded, Non-inferiority Investigator Initiative Clinical Trial to Evaluate the Efficacy and Safety of Acute Bronchitis Symptoms Improvement for Bronpass Tab. Compared to Erdos Capsule on Patients With Acute Bronchitis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kwang-Ha Yoo</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Hanlim Pharm. Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Konkuk University Medical Center</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this clinical trial is to evaluate the acute bronchitis symptom relief effect&#xD;
        of Bronpass tab. compared to Erdos capsule, and compare and evaluate the safety.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of this clinical trial is to evaluate the following in patients with acute&#xD;
        bronchitis at the 7th day of administration of the investigational drug.&#xD;
  &#xD;
        primary purpose: Prove the non-inferiority of the acute bronchitis symptom relief effect of&#xD;
        Bronpass tab. compared to Erdos capsule, and compare and evaluate the safety.&#xD;
  &#xD;
        secondary purpose: Compare and evaluate the effect of improving clinical symptoms, including&#xD;
        sputum symptoms, of Bronpass tab. compared to Erdos capsule.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 15, 2022</start_date>
    <completion_date type="Actual">May 16, 2023</completion_date>
    <primary_completion_date type="Actual">December 28, 2022</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>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in BSS(Bronchitis severity score) total score</measure>
      <time_frame>Visit 3 (Day 7)</time_frame>
      <description>Change in BSS(Bronchitis severity score) total score at 7 days after administration of investigational drug compared to baseline&#xD;
  * The total BSS score ranges from 0 to 20, with higher scores indicating greater severity of symptoms.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in BSS(Bronchitis severity score) score by symptom (cough, sputum, dyspnea, chest pain when coughing, crackles/rhonchus)</measure>
      <time_frame>Visit 3 (Day 7)</time_frame>
      <description>Change in BSS(Bronchitis severity score) score by symptom (cough, sputum, dyspnea, chest pain when coughing, crackles/rhonchus) at 7 days after administration of the investigational drug compared to baseline&#xD;
  * The BSS score range for each symptom is 0 to 4 with a higher score indicating a greater severity of symptom.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall improvement as assessed by the investigator using the investigator's overall improvement evaluation sheet (5-point scale)</measure>
      <time_frame>Visit 3 (Day 7)</time_frame>
      <description>Overall improvement judged by the investigator on the treatment response at 7 days after administration of the investigational product&#xD;
  * The investigator's overall improvement evaluation sheet is a 5-point scale(ranges from 1 to 5) evaluation sheet where a higher score indicates a greater improvement of the subject's symptom.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Satisfaction evaluated by the subject using the subject's satisfaction evaluation sheet (5-point scale)</measure>
      <time_frame>Visit 3 (Day 7)</time_frame>
      <description>Satisfaction of subjects on the treatment response at 7 days after administration of investigational drug&#xD;
  * The subject's satisfaction evaluation sheet is a 5-point scale(ranges from 1 to 5) evaluation sheet where a higher score indicates a greater satisfaction.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of rescue drug doses</measure>
      <time_frame>Visit 3 (Day 7)</time_frame>
      <description>Number of rescue drug doses at 7 days after administration of investigational drug</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in inflammatory marker (CRP in mg/L) at 7 days after administration of investigational drugs compared to baseline</measure>
      <time_frame>Visit 3 (Day 7)</time_frame>
      <description>Present the descriptive statistics (Mean, standard deviation, median value, minimum value, maximum value) for the change in inflammatory marker (CRP in mg/L) at 7 days after administration of the investigational drug. And compare the difference in the amount of change between the groups on the 7th day compared to the baseline.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in inflammatory marker (TNF-α in pg/mL) at 7 days after administration of investigational drugs compared to baseline</measure>
      <time_frame>Visit 3 (Day 7)</time_frame>
      <description>Present the descriptive statistics (Mean, standard deviation, median value, minimum value, maximum value) for the change in inflammatory marker (TNF-α in pg/mL) at 7 days after administration of the investigational drug. And compare the difference in the amount of change between the groups on the 7th day compared to the baseline.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in inflammatory marker (IL-1β in pg/mL) at 7 days after administration of investigational drugs compared to baseline</measure>
      <time_frame>Visit 3 (Day 7)</time_frame>
      <description>Present the descriptive statistics (Mean, standard deviation, median value, minimum value, maximum value) for the change in inflammatory marker (IL-1β in pg/mL) at 7 days after administration of the investigational drug. And compare the difference in the amount of change between the groups on the 7th day compared to the baseline.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in inflammatory marker (IL-6 in pg/mL) at 7 days after administration of investigational drugs compared to baseline</measure>
      <time_frame>Visit 3 (Day 7)</time_frame>
      <description>Present the descriptive statistics (Mean, standard deviation, median value, minimum value, maximum value) for the change in inflammatory marker (IL-6 in pg/mL) at 7 days after administration of the investigational drug. And compare the difference in the amount of change between the groups on the 7th day compared to the baseline.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">110</enrollment>
    <condition>Acute Bronchitis</condition>
    <arm_group>
      <arm_group_label>Bronpass Tab.</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Erdos capsule</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Bronpass Tab.</intervention_name>
      <description>Twice a day</description>
      <arm_group_label>Bronpass Tab.</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo of Erdos capsule</intervention_name>
      <description>Three times a day (It is for the masking.)</description>
      <arm_group_label>Bronpass Tab.</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Erdos capsule</intervention_name>
      <description>Three times a day</description>
      <arm_group_label>Erdos capsule</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo of Bronpass Tab.</intervention_name>
      <description>Twice a day (It is for the masking.)</description>
      <arm_group_label>Erdos capsule</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Adult aged 19 to 80 at the time of screening&#xD;
  &#xD;
            2. Patients with an acute bronchitis severity score (BSS) of 5 or higher at the time of&#xD;
               screening and the first day of administration of the investigational drug&#xD;
  &#xD;
            3. Patients with symptoms of acute bronchitis within 48 hours from the time of screening&#xD;
  &#xD;
            4. Patients who voluntarily gave written consent to participate in this clinical trial&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with a known hypersensitivity reaction to the components of this&#xD;
               investigational product&#xD;
  &#xD;
            2. Patients with respiratory and systemic infections requiring systemic antibiotic&#xD;
               treatment&#xD;
  &#xD;
            3. Patients with clotting disorders or bleeding tendencies&#xD;
  &#xD;
            4. Patients with peptic ulcer at the time of screening&#xD;
  &#xD;
            5. Severe lung diseases that may affect the efficacy evaluation of this clinical trial at&#xD;
               the discretion of the investigator&#xD;
  &#xD;
            6. For screening test results, creatinine clearance &lt; 25 mL/min or AST, ALT more than 3&#xD;
               times the upper limit of normal&#xD;
  &#xD;
            7. A person who have administered systemic corticosteroids or immunosuppressants within 4&#xD;
               weeks of the first administration of the investigational drug&#xD;
  &#xD;
            8. A person who have administered antiviral drugs, systemic/inhaled glucocorticosteroids&#xD;
               within 48 hours of the first administration of investigational drugs&#xD;
  &#xD;
            9. A person who have administered mucolytics, sputum discharge agents, antitussives,&#xD;
               herbal medicines with antitussive/ expectorant effects, and antihistamines within 48&#xD;
               hours of the first administration of investigational drugs&#xD;
  &#xD;
           10. A person who need or plan to take contraindicated drugs or therapies during this&#xD;
               clinical trial period&#xD;
  &#xD;
           11. Patient with liver cirrhosis or cystathionine synthetase deficiency&#xD;
  &#xD;
           12. Patient who have clinically significant diseases and disorders in the cardiovascular&#xD;
               system, endocrine system, and central nervous system at the time of screening, or who&#xD;
               have a history of malignant tumors or mental disorders (eg. depression) (However,&#xD;
               participation is possible if there is no recurrence for more than 5 years after&#xD;
               surgery at the time of screening)&#xD;
  &#xD;
           13. A person with a history of alcoholism or drug abuse&#xD;
  &#xD;
           14. Heavy smokers (more than 15 cigarettes per day) within 4 weeks from the time of&#xD;
               screening&#xD;
  &#xD;
           15. Pregnant or lactating&#xD;
  &#xD;
           16. Among female subjects of childbearing potential, women who do not intend to use&#xD;
               appropriate contraceptive methods or plan to become pregnant during this clinical&#xD;
               trial&#xD;
  &#xD;
           17. A person who administered other investigational drugs within 4 weeks from the time of&#xD;
               screening&#xD;
  &#xD;
           18. A person who are not suitable for participation in this clinical trial under the&#xD;
               judgment of the investigator&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Konkuk University Hospital</name>
        <address>
          <city>Seoul</city>
          <zip>05030</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Konkuk University Medical Center</investigator_affiliation>
      <investigator_full_name>Kwang-Ha Yoo</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bronchitis</mesh_term>
      <mesh_term>Acute Disease</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/NCT06038084
  org study id: HL-BRPS-501
  nct id: NCT06038084
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this clinical trial is to evaluate the acute bronchitis symptom relief effect
        of Bronpass tab. compared to Erdos capsule, and compare and evaluate the safety.
  The purpose of this clinical trial is to evaluate the following in patients with acute
        bronchitis at the 7th day of administration of the investigational drug.
  
        primary purpose: Prove the non-inferiority of the acute bronchitis symptom relief effect of
        Bronpass tab. compared to Erdos capsule, and compare and evaluate the safety.
  
        secondary purpose: Compare and evaluate the effect of improving clinical symptoms, including
        sputum symptoms, of Bronpass tab. compared to Erdos capsule.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Change in BSS(Bronchitis severity score) total score
  time frame: Visit 3 (Day 7)
  description: Change in BSS(Bronchitis severity score) total score at 7 days after administration of investigational drug compared to baseline
  * The total BSS score ranges from 0 to 20, with higher scores indicating greater severity of symptoms.
  measure: Change in BSS(Bronchitis severity score) score by symptom (cough, sputum, dyspnea, chest pain when coughing, crackles/rhonchus)
  time frame: Visit 3 (Day 7)
  description: Change in BSS(Bronchitis severity score) score by symptom (cough, sputum, dyspnea, chest pain when coughing, crackles/rhonchus) at 7 days after administration of the investigational drug compared to baseline
  * The BSS score range for each symptom is 0 to 4 with a higher score indicating a greater severity of symptom.
  measure: Overall improvement as assessed by the investigator using the investigator's overall improvement evaluation sheet (5-point scale)
  time frame: Visit 3 (Day 7)
  description: Overall improvement judged by the investigator on the treatment response at 7 days after administration of the investigational product
  * The investigator's overall improvement evaluation sheet is a 5-point scale(ranges from 1 to 5) evaluation sheet where a higher score indicates a greater improvement of the subject's symptom.
  measure: Satisfaction evaluated by the subject using the subject's satisfaction evaluation sheet (5-point scale)
  time frame: Visit 3 (Day 7)
  description: Satisfaction of subjects on the treatment response at 7 days after administration of investigational drug
  * The subject's satisfaction evaluation sheet is a 5-point scale(ranges from 1 to 5) evaluation sheet where a higher score indicates a greater satisfaction.
  measure: Number of rescue drug doses
  time frame: Visit 3 (Day 7)
  description: Number of rescue drug doses at 7 days after administration of investigational drug
  measure: Changes in inflammatory marker (CRP in mg/L) at 7 days after administration of investigational drugs compared to baseline
  time frame: Visit 3 (Day 7)
  description: Present the descriptive statistics (Mean, standard deviation, median value, minimum value, maximum value) for the change in inflammatory marker (CRP in mg/L) at 7 days after administration of the investigational drug. And compare the difference in the amount of change between the groups on the 7th day compared to the baseline.
  measure: Changes in inflammatory marker (TNF-α in pg/mL) at 7 days after administration of investigational drugs compared to baseline
  time frame: Visit 3 (Day 7)
  description: Present the descriptive statistics (Mean, standard deviation, median value, minimum value, maximum value) for the change in inflammatory marker (TNF-α in pg/mL) at 7 days after administration of the investigational drug. And compare the difference in the amount of change between the groups on the 7th day compared to the baseline.
  measure: Changes in inflammatory marker (IL-1β in pg/mL) at 7 days after administration of investigational drugs compared to baseline
  time frame: Visit 3 (Day 7)
  description: Present the descriptive statistics (Mean, standard deviation, median value, minimum value, maximum value) for the change in inflammatory marker (IL-1β in pg/mL) at 7 days after administration of the investigational drug. And compare the difference in the amount of change between the groups on the 7th day compared to the baseline.
  measure: Changes in inflammatory marker (IL-6 in pg/mL) at 7 days after administration of investigational drugs compared to baseline
  time frame: Visit 3 (Day 7)
  description: Present the descriptive statistics (Mean, standard deviation, median value, minimum value, maximum value) for the change in inflammatory marker (IL-6 in pg/mL) at 7 days after administration of the investigational drug. And compare the difference in the amount of change between the groups on the 7th day compared to the baseline.
  arm group label: Bronpass Tab.
  arm group type: Experimental
  arm group label: Erdos capsule
  arm group type: Active Comparator
  intervention type: Drug
  intervention name: Bronpass Tab.
  description: Twice a day
  arm group label: Bronpass Tab.
  intervention type: Drug
  intervention name: Placebo of Erdos capsule
  description: Three times a day (It is for the masking.)
  arm group label: Bronpass Tab.
  intervention type: Drug
  intervention name: Erdos capsule
  description: Three times a day
  arm group label: Erdos capsule
  intervention type: Drug
  intervention name: Placebo of Bronpass Tab.
  description: Twice a day (It is for the masking.)
  arm group label: Erdos capsule
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: 80 Years
  healthy volunteers: No
  facility: 
  country: Korea, Republic of
  responsible party type: Sponsor-Investigator
  investigator affiliation: Konkuk University Medical Center
  investigator full name: Kwang-Ha Yoo
  investigator title: Professor
  mesh term: Bronchitis
  mesh term: Acute Disease