Efficacy and Safety of GHX02 in the Treatment of Acute Bronchitis

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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Bronchitis
• Intervention / Treatment: Drug: Placebo; Drug: GHX02

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: YeeRan Lyu; Phone Number: 82424709663; Email: yyr900511@gmail.com

Study Locations

• Korea, Republic of
  • Daejeon, Korea, Republic of
    • Dunsan Korean Medicine Hospital, Daejeon University
    • Contact: Yee Ran Lyu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Daejeon University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 18, 2019
• Primary Completion (ANTICIPATED): March 1, 2020
• Study Completion (ANTICIPATED): March 1, 2020

Study Registration Dates

• First Submitted: October 6, 2017
• First Submitted That Met QC Criteria: October 10, 2017
• First Posted (ACTUAL): October 16, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 5, 2019
• Last Update Submitted That Met QC Criteria: March 1, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Acute Bronchitis, Herbal Medicine
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Bronchial Diseases; Lung Diseases, Obstructive; Acute Disease; Bronchitis
• Other Study ID Numbers: DJRM-2017-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No