Efficacy and Safety of GHX02 in the Treatment of Acute Bronchitis

Acute Bronchitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03310385
• Other study ID #: DJRM-2017-01
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 18, 2019
• Est. completion date: March 2020

Study information

• Verified date: March 2019
• Source: Daejeon University
• Contact: YeeRan Lyu
• Phone: 82424709663
• Email: yyr900511[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Bronchitis
• Acute Disease
• Bronchitis

Intervention

Drug:
• GHX02
Herbal medicine originating from gualouhengryunhwan
• Placebo
Placebo tablets

Locations

Country	Name	City	State
Korea, Republic of	Dunsan Korean Medicine Hospital, Daejeon University	Daejeon

Sponsors (1)

Lead Sponsor	Collaborator
Daejeon University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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