Efficacy and Safety of GHX02 in the Treatment of Acute Bronchitis

NCT03310385 | Unknown Phase 2 DMC

• 1 other identifier: DJRM-2017-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Bronchitis

Keywords

Acute Bronchitis, Herbal Medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in Questionnaire of Clinical Symptoms of Cough and Sputum

  Day0, Day7

• Change in Leicester Cough Questionnaire-acute(LCQ-acute)

  Day0, Day7

• Change in frequency of coughing fits

  Day0, Day1, Day2, Day3, Day4, Day5, Day6, Day7

• Integrative Medicine Outcome Scale(IMOS)

  Day7

• Integrative Medicine Patient Satisfaction Scale(IMPSS)

  Day7

Study Arms (3)

High-dose GHX02 group(1,920mg/day)

EXPERIMENTAL

4 tablets of the GHX02, three times daily for 7 days

Drug: GHX02

Standard-dose GHX02 group(960mg/day)

EXPERIMENTAL

2 tablets of the GHX02 and 2 tablets of the placebo, three times daily for 7 days

Drug: GHX02; Drug: Placebo

Placebo control

PLACEBO COMPARATOR

4 tablets of the placebo, three times daily for 7 days

Drug: Placebo

Interventions

GHX02 DRUG

Herbal medicine originating from gualouhengryunhwan

High-dose GHX02 group(1,920mg/day); Standard-dose GHX02 group(960mg/day)

Placebo DRUG

Placebo tablets

Placebo control; Standard-dose GHX02 group(960mg/day)

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 19-75 years
• BSS ≥ 5 points at visit2 due to acute bronchitis
• patients who consent to participate

You may not qualify if:

• pregnant or breast-feeding
• 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
• judged by the investigators to be inappropriate for the clinical trial.

Sponsors & Collaborators

• Daejeon University: lead

Study Sites (1)

Dunsan Korean Medicine Hospital, Daejeon University

Daejeon, South Korea

Location

Related Publications (2)

• 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.

  PMID: 31515828 DERIVED

• 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.

  PMID: 29764875 DERIVED

MeSH Terms

Conditions

Bronchitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Central Study Contacts

YeeRan Lyu

CONTACT

82424709663; yyr900511@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: multicentre, dose-finding,double-blind, randomized placebo-controlled trial

Study Record Dates

• First Submitted: October 6, 2017
• First Posted: October 16, 2017
• Study Start: March 18, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: March 5, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

KR (1)