Efficacy and Safety of GHX02 in the Treatment of Acute Bronchitis: a Phase 2, Double-blind, Randomized Placebo-controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in BSS(Bronchitis Severity Score)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
double-blind
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
High-dose GHX02 group(1,920mg/day)
4 tablets of the GHX02, three times daily for 7 days
干预措施: GHX02 (Drug)
Standard-dose GHX02 group(960mg/day)
2 tablets of the GHX02 and 2 tablets of the placebo, three times daily for 7 days
干预措施: GHX02 (Drug)
Standard-dose GHX02 group(960mg/day)
2 tablets of the GHX02 and 2 tablets of the placebo, three times daily for 7 days
干预措施: Placebo (Drug)
Placebo control
4 tablets of the placebo, three times daily for 7 days
干预措施: Placebo (Drug)
结局指标
主要结局
Change in BSS(Bronchitis Severity Score)
时间窗: Day0, Day7
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.
次要结局
- Change in Questionnaire of Clinical Symptoms of Cough and Sputum(Day0, Day7)
- Change in frequency of coughing fits(Day0, Day1, Day2, Day3, Day4, Day5, Day6, Day7)
- Integrative Medicine Outcome Scale(IMOS)(Day7)
- Change in Leicester Cough Questionnaire-acute(LCQ-acute)(Day0, Day7)
- Integrative Medicine Patient Satisfaction Scale(IMPSS)(Day7)
研究者
Yang Chun Park
Professor
Daejeon University