Clinical trial NCT03310385: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Bronchitis
Keywords: Acute Bronchitis, Herbal Medicine
Lead sponsor: Daejeon University
Sponsor class: OTHER
First posted: 2017-10-16
Enrollment: 150
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: multicentre, dose-finding,double-blind, randomized placebo-controlled trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in BSS(Bronchitis Severity Score)
timeFrame: Day0, Day7
Secondary outcomes:
measure: Change in Questionnaire of Clinical Symptoms of Cough and Sputum
timeFrame: Day0, Day7
measure: Change in Leicester Cough Questionnaire-acute(LCQ-acute)
timeFrame: Day0, Day7
measure: Change in frequency of coughing fits
timeFrame: Day0, Day1, Day2, Day3, Day4, Day5, Day6, Day7
measure: Integrative Medicine Outcome Scale(IMOS)
timeFrame: Day7
measure: Integrative Medicine Patient Satisfaction Scale(IMPSS)
timeFrame: Day7
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Dunsan Korean Medicine Hospital, Daejeon University
Study officials:
References:
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.
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.