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Efficacy and safety of GHX02 in the treatment of acute bronchitis and acute exacerbation of chronic bronchitis: A phase Ⅱ, randomized, double-blind, placebo-controlled, multicenter trial

Status Approved

  • First Submitted Date

    2019/03/05

  • Registered Date

    2019/03/25

  • Last Updated Date

    2021/08/20

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0003665
    Unique Protocol ID DJRM-2017-01
    Public/Brief Title Efficacy and safety of GHX02 in the treatment of acute bronchitis and acute exacerbation of chronic bronchitis
    Scientific Title Efficacy and safety of GHX02 in the treatment of acute bronchitis and acute exacerbation of chronic bronchitis: A phase Ⅱ, randomized, double-blind, placebo-controlled, multicenter trial
    Acronym GHX02
    MFDS Regulated Study Yes
    IND/IDE Protocol Yes
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number DJDSKH-17-DR-22
    Approval Date 2019-02-01
    Institutional Review Board Name Daejeon University Dunsan Korean Medicine Hospital Institutional Review Board
    Institutional Review Board Address 75, Daedeok-daero 176beon-gil, Seo-gu, Daejeon
    Institutional Review Board Telephone 042-470-9488
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name YangChun Park
    Title Ph.D
    Telephone +82-42-470-9126
    Affiliation Dunsan Korean Medicine Hospital of Daejeon University
    Address 75, Daedeok-daero 176beon-gil, Seo-gu, Daejeon
    Contact Person for Public Queries
    Name YeeRan Lyu
    Title KMD
    Telephone +82-42-470-9663
    Affiliation Dunsan Korean Medicine Hospital of Daejeon University
    Address 75, Daedeok-daero 176beon-gil, Seo-gu, Daejeon
    Contact Person for Updating Information
    Name YeeRan Lyu
    Title KMD
    Telephone +82-42-470-9663
    Affiliation Dunsan Korean Medicine Hospital of Daejeon University
    Address 75, Daedeok-daero 176beon-gil, Seo-gu, Daejeon
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Multi-center Number of center : 3
    Overall Recruitment Status Completed
    Date of First Enrollment 2019-03-16 Actual
    Target Number of Participant 117
    Primary Completion Date 2019-12-05 , Actual
    Study Completion Date 2019-12-05 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Daejeon Korean Medicine Hospital of Daejeon University
    Recruitment Status Recruiting
    Date of First Enrollment 2019-03-16 ,
    Recruitment Status by Participating Study Site 2
    Name of Study Kyung Hee University Oriental Medical Center
    Recruitment Status Recruiting
    Date of First Enrollment 2019-06-26 ,
    Recruitment Status by Participating Study Site 3
    Name of Study Pusan National University Korean Medicine Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2019-06-05 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Korea Institute of Oriental Medicine
    Organization Type Others
    Project ID K17510
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Daejeon Korean Medicine Hospital of Daejeon University
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    The objective is to compare the GHX02 and placebo in terms of efficacy and safety, and to determine the appropriate dosage. We planned a phase 2, multicentre, dose-finding, double-blind, randomized placebo-controlled trial of two different doses of GHX02 compared with placebo. A total of 117 patients, aged 19-75 years, with a Bronchitis Severity Score (BSS)≥5 due to acute bronchitis or acute exacerbation of chronic bronchitis starting within 2 weeks of study enrolment will be recruited from three university-affiliated hospitals across Korea. Participants will be stratified into three patterns(wind-heat, wind-cold, others) by pattern identification and randomly assigned to either a high-dose GHX02 group(1,920mg/day), standard-dose GHX02 group(960mg/day), or placebo group according to a 1:1:1 allocation ratio. Patients will take medications three times daily for 7 days, with 2 visiting days.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Phase2
    Intervention Model Parallel  
    Blinding/Masking Double
    Blinded Subject Subject, Investigator, Outcome Accessor
    Allocation RCT
    Intervention Type Drug  
    Intervention Description
    Participants will be randomly assigned to either a high-dose GHX02 group(1,920mg/day), a standard-dose GHX02 group(960mg/day), or a placebo group(control) according to a 1:1:1 allocation ratio using stratification block randomization with pattern identification. Patients will take medications three times daily for 7 days, with 3 visiting days(screening, day0, day7)
    Number of Arms 3
    Arm 1

    Arm Label

    standard-dose GHX02

    Target Number of Participant

    39

    Arm Type

    Experimental

    Arm Description

    2 tablets of the clinical medicine and 2 tablets of the placebo, administered three times daily for 7 days
    Arm 2

    Arm Label

    high-dose GHX02

    Target Number of Participant

    39

    Arm Type

    Experimental

    Arm Description

    4 tablets of the clinical medicine, administered three times daily for 7 days
    Arm 3

    Arm Label

    placebo

    Target Number of Participant

    39

    Arm Type

    Placebo comparator

    Arm Description

    4 tablets of the placebo, administered three times daily for 7 days
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (J00-J99)Diseases of the respiratory system 
       (J42)Unspecified chronic bronchitis 

    acute bronchitis or acute exacerbation of chronic bronchitis
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~75Year

    Description

    1) aged 19–75 years 
    2) BSS ≥ 5 points at visit 2 due to acute bronchitis starting within 2 weeks before study inclusion or due to acute exacerbation of chronic bronchitis with increased respiratory symptoms for more than 2 days.
    3) patients who consent to participate
    Exclusion Criteria
    1) pregnant or breast-feeding 
    2) treatment with antibiotics, bronchodilators, glucocorticoids, immune-depressants, or other clinical trial medicines during the last 4 weeks before study inclusion 
    3) treatment with antitussives or expectorants during the last 7 days before study inclusion 
    4) requiring treatment of  antibiotics, bronchodilators, glucocorticoids
    5) history or presence of confounding respiratory disease that may affect evaluation of the efficacy of clinical medicine (e.g. chronic bronchitis, chronic obstructive pulmonary disease (COPD), bronchiectasis, asthma, pneumonia, cystic fibrosis, lung cancer, or active pulmonary tuberculosis) 
    6) liver or renal impairment (alanine aminotransferase(ALT), aspartate aminotransferase(AST), alkaline phosphatase(ALP) ≥ 3 times the normal upper limit, or creatinine> 3.0 mg/dL at screening) 
    7) genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
    8) history or presence of clinically relevant cardiovascular, renal, metabolic, haematological, neurological, psychiatric, systemic, infectious disease, or malignant tumour(except where there is no recurrence for more than 5 years after surgery) 
    9) history of alcoholism or substance abuse 
    10) smokers of more than 30 years
    11) disagree with contraception
    12) participation in other clinical drug(medicine) trials during the last 30 days before study inclusion 
    13) judged by the investigators to be inappropriate for the clinical trial.
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome /Safety/Efficacy
    Primary Outcome(s) 1
    Outcome
    change in BSS(Bronchitis Severity Score) from visit2 to visit3
    Timepoint
    visit2, visit3
    Secondary Outcome(s) 1
    Outcome
    Change in Questionnaire of Clinical Symptoms of Cough and Sputum
    Timepoint
    visit2, visit3
    Secondary Outcome(s) 2
    Outcome
    Change in Leicester Cough Questionnaire-acute(LCQ-acute)
    Timepoint
    visit2, visit3
    Secondary Outcome(s) 3
    Outcome
    Change in frequency of coughing fits
    Timepoint
    visit2, visit3
    Secondary Outcome(s) 4
    Outcome
    Integrative Medicine Outcome Scale(IMOS)
    Timepoint
    visit3
    Secondary Outcome(s) 5
    Outcome
    Integrative Medicine Patient Satisfaction Scale(IMPSS)
    Timepoint
    visit3
    Secondary Outcome(s) 6
    Outcome
    adverse effect
    Timepoint
    visit2, visit3
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Yes
    Time of Sharing 2020. 3
    Way of Sharing To be made available at a later date
    (ryr8049@naver.com)
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