Efficacy and Safety of GHX02 in the Treatment of Acute Bronchitis

Daejeon University

Status and phase: Unknown; Phase 2

Conditions: Acute Bronchitis

Treatments: Drug: Placebo; Drug: GHX02

Study type: Interventional

Funder types: Other

Identifiers

NCT03310385

DJRM-2017-01

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 3 patient groups, including a placebo group

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

Experimental group

Description:

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

Treatment:

Drug: GHX02

Standard-dose GHX02 group(960mg/day)

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: GHX02

Placebo control

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo