Status:
UNKNOWN
Efficacy and Safety of GHX02 in the Treatment of Acute Bronchitis
Lead Sponsor:
Daejeon University
Conditions:
Acute Bronchitis
Eligibility:
All Genders
19-75 years
Phase:
PHASE2
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 ac...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
March 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2020
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03310385
Start Date
March 18 2019
End Date
March 1 2020
Last Update
March 5 2019
Active Locations (1)
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1
Dunsan Korean Medicine Hospital, Daejeon University
Daejeon, South Korea