Efficacy and Safety of GHX02 in the Treatment of Acute Bronchitis

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of GHX02 in the Treatment of Acute Bronchitis: a Phase 2, Double-blind, Randomized Placebo-controlled Trial

Conditions
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Acute Bronchitis

Intervention / Treatment
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* Drug: GHX02
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: multicentre, dose-finding,double-blind, randomized placebo-controlled trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-dose GHX02 group(1,920mg/day)<br>4 tablets of the GHX02, three times daily for 7 days | Drug: GHX02<br>* Herbal medicine originating from gualouhengryunhwan<br>|
| Experimental: Standard-dose GHX02 group(960mg/day)<br>2 tablets of the GHX02 and 2 tablets of the placebo, three times daily for 7 days | Drug: GHX02<br>* Herbal medicine originating from gualouhengryunhwan<br>Drug: Placebo<br>* Placebo tablets<br>|
| Placebo Comparator: Placebo control<br>4 tablets of the placebo, three times daily for 7 days | Drug: Placebo<br>* Placebo tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day0, Day7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day0, Day7 | 
| 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. | Day0, Day7 | 
| 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). | Day0, Day1, Day2, Day3, Day4, Day5, Day6, Day7 | 
| 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). | Day7 | 
| 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) | Day7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Bronchitis, Herbal Medicine