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Efficacy and Safety of GHX02 in the Treatment of Acute Bronchitis

Primary Purpose

Acute Bronchitis

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
GHX02
Placebo
Sponsored by
Daejeon University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Bronchitis focused on measuring Acute Bronchitis, Herbal Medicine

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. age 19-75 years
  2. BSS ≥ 5 points at visit2 due to acute bronchitis
  3. symptoms starting within 2 weeks before study inclusion
  4. 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. 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)
  5. 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)
  6. 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)
  7. history of alcoholism or substance abuse
  8. participation in other clinical drug(medicine) trials during the last 30 days before study inclusion
  9. judged by the investigators to be inappropriate for the clinical trial.

Sites / Locations

  • Dunsan Korean Medicine Hospital, Daejeon University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

High-dose GHX02 group(1,920mg/day)

Standard-dose GHX02 group(960mg/day)

Placebo control

Arm Description

4 tablets of the GHX02, three times daily for 7 days

2 tablets of the GHX02 and 2 tablets of the placebo, three times daily for 7 days

4 tablets of the placebo, three times daily for 7 days

Outcomes

Primary Outcome Measures

Change in BSS(Bronchitis Severity Score)
BSS comprises the sum of five major symptom scores for acute bronchitis: cough, sputum, dyspnea, chest pain during coughing, and rales on auscultation. Each symptom is scored on a 4-point-scale (0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe), with a maximum total score of 20 points. The investigator assesses symptom scores on the basis of the patient's subjective symptoms.

Secondary Outcome Measures

Change in Questionnaire of Clinical Symptoms of Cough and Sputum
Questionnaire items are as follows: (1) cough -frequency, intensity, sensitivity; (2) sputum -frequency, volume, difficulty to cough-up, appearance, color; (3) activities of daily living; (4) night-time sleeping. Each item is scored on a 4-point-scale, with a total maximum score of 40 points.
Change in Leicester Cough Questionnaire-acute(LCQ-acute)
It consists of 19 items divided into three parts, physical, psychological, and social, each scored from 1 to 7. The total score is the sum of the average scores(1-7 points) for each part. The higher the score, the better the quality of life.
Change in frequency of coughing fits
participants will be classified into one of the following scales: 0 = 0 time/day, 1 = 1 time/day, 2 = 2-3 times/day, 3 = 4-5 times/day(sometimes), 4 = 6-10 times/day(frequent), 5 = over 15 times/day(consistently).
Integrative Medicine Outcome Scale(IMOS)
It's a 5-point-scale for evaluating improvement after treatment (where, 1=complete recovery, 2=major improvement, 3=slight-to-moderate improvement, 4=no change, 5=deterioration), either by the patient or investigator (the investigator in this trial).
Integrative Medicine Patient Satisfaction Scale(IMPSS)
It's a 5-point-scale for evaluating patient satisfaction with the treatment (where, 1=very satisfied, 2=satisfied, 3=neutral, 4=dissatisfied, 5=very dissatisfied)

Full Information

First Posted
October 6, 2017
Last Updated
March 1, 2019
Sponsor
Daejeon University
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1. Study Identification

Unique Protocol Identification Number
NCT03310385
Brief Title
Efficacy and Safety of GHX02 in the Treatment of Acute Bronchitis
Official Title
Efficacy and Safety of GHX02 in the Treatment of Acute Bronchitis: a Phase 2, Double-blind, Randomized Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 18, 2019 (Anticipated)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
March 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Daejeon University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is a phase 2, multicentre, dose-finding, double-blind, randomized placebo-controlled trial to evaluate the efficacy and safety of two different doses of GHX02, compared with placebo, for acute bronchitis. One-hundred and fifty patients will be included in this trial and randomly assigned to either a high-dose GHX02 group(1920mg/day), standard-dose GHX02 group(960mg/day), or control group(placebo) in a 1:1:1 allocation ratio. Patients will take one of the medications three times a day for 7 days, with 3 visiting days(screening, day0, day7). On the screening day, the Korean Standard Tool of Pattern Identification of Cough and Sputum, a diagnostic system that determines therapy in Traditional Korean Medicine, will be used to allocate patients into three groups of wind-heat, wind-cold or others.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Bronchitis
Keywords
Acute Bronchitis, Herbal Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
multicentre, dose-finding,double-blind, randomized placebo-controlled trial
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
double-blind
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-dose GHX02 group(1,920mg/day)
Arm Type
Experimental
Arm Description
4 tablets of the GHX02, three times daily for 7 days
Arm Title
Standard-dose GHX02 group(960mg/day)
Arm Type
Experimental
Arm Description
2 tablets of the GHX02 and 2 tablets of the placebo, three times daily for 7 days
Arm Title
Placebo control
Arm Type
Placebo Comparator
Arm Description
4 tablets of the placebo, three times daily for 7 days
Intervention Type
Drug
Intervention Name(s)
GHX02
Intervention Description
Herbal medicine originating from gualouhengryunhwan
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets
Primary Outcome Measure Information:
Title
Change in BSS(Bronchitis Severity Score)
Description
BSS comprises the sum of five major symptom scores for acute bronchitis: cough, sputum, dyspnea, chest pain during coughing, and rales on auscultation. Each symptom is scored on a 4-point-scale (0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe), with a maximum total score of 20 points. The investigator assesses symptom scores on the basis of the patient's subjective symptoms.
Time Frame
Day0, Day7
Secondary Outcome Measure Information:
Title
Change in Questionnaire of Clinical Symptoms of Cough and Sputum
Description
Questionnaire items are as follows: (1) cough -frequency, intensity, sensitivity; (2) sputum -frequency, volume, difficulty to cough-up, appearance, color; (3) activities of daily living; (4) night-time sleeping. Each item is scored on a 4-point-scale, with a total maximum score of 40 points.
Time Frame
Day0, Day7
Title
Change in Leicester Cough Questionnaire-acute(LCQ-acute)
Description
It consists of 19 items divided into three parts, physical, psychological, and social, each scored from 1 to 7. The total score is the sum of the average scores(1-7 points) for each part. The higher the score, the better the quality of life.
Time Frame
Day0, Day7
Title
Change in frequency of coughing fits
Description
participants will be classified into one of the following scales: 0 = 0 time/day, 1 = 1 time/day, 2 = 2-3 times/day, 3 = 4-5 times/day(sometimes), 4 = 6-10 times/day(frequent), 5 = over 15 times/day(consistently).
Time Frame
Day0, Day1, Day2, Day3, Day4, Day5, Day6, Day7
Title
Integrative Medicine Outcome Scale(IMOS)
Description
It's a 5-point-scale for evaluating improvement after treatment (where, 1=complete recovery, 2=major improvement, 3=slight-to-moderate improvement, 4=no change, 5=deterioration), either by the patient or investigator (the investigator in this trial).
Time Frame
Day7
Title
Integrative Medicine Patient Satisfaction Scale(IMPSS)
Description
It's a 5-point-scale for evaluating patient satisfaction with the treatment (where, 1=very satisfied, 2=satisfied, 3=neutral, 4=dissatisfied, 5=very dissatisfied)
Time Frame
Day7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 19-75 years BSS ≥ 5 points at visit2 due to acute bronchitis symptoms starting within 2 weeks before study inclusion patients who consent to participate Exclusion Criteria: pregnant or breast-feeding treatment with antibiotics, bronchodilators, glucocorticoids, immune-depressants, or other clinical trial medicines during the last 4 weeks before study inclusion treatment with antitussives or expectorants during the last 7 days before study inclusion 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) 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) 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) history of alcoholism or substance abuse participation in other clinical drug(medicine) trials during the last 30 days before study inclusion judged by the investigators to be inappropriate for the clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YeeRan Lyu
Phone
82424709663
Email
yyr900511@gmail.com
Facility Information:
Facility Name
Dunsan Korean Medicine Hospital, Daejeon University
City
Daejeon
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yee Ran Lyu

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
31515828
Citation
Ji KY, Kim KM, Oh JJ, Kim JW, Lee WJ, Cho H, Lee HK, Lee JY, Chae S. Assessment of the 4-week repeated-dose oral toxicity and genotoxicity of GHX02. J Appl Toxicol. 2020 Feb;40(2):270-284. doi: 10.1002/jat.3902. Epub 2019 Sep 12.
Results Reference
derived
PubMed Identifier
29764875
Citation
Lyu YR, Yang WK, Park SJ, Kim SH, Kang WC, Jung IC, Park YC. Efficacy and safety of GHX02 in the treatment of acute bronchitis: protocol of a phase II, double-blind, randomised placebo-controlled trial. BMJ Open. 2018 May 14;8(5):e019897. doi: 10.1136/bmjopen-2017-019897.
Results Reference
derived

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Efficacy and Safety of GHX02 in the Treatment of Acute Bronchitis

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