Acute Bronchitis
Conditions
Brief summary
A Multicenter, Randomized, Double-Blind, Parallel, Active-controlled, Superiority, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW1601 Compared to DW16011 and DW16012 for Acute Bronchitis
Interventions
DRUGDW1601
Total 7 days of treatment and The daily dose is tid. (DW1601 20ml + Placebo of DW16011 20ml + Placebo of DW16012 9ml)
DRUGDW16011
Total 7 days of treatment and The daily dose is tid. (Placebo of DW1601 20ml + DW16011 20ml + Placebo of DW16012 9ml)
DRUGDW16012
Total 7 days of treatment and The daily dose is tid. (Placebo of DW1601 20ml + Placebo of DW16011 20ml + DW16012 9ml)
Sponsors
Daewon Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blind
Eligibility
Sex/Gender
ALL
Age
19 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Both gender, 19 years ≤ age ≤ 80 years * Bronchitis Severity Score\* ≥ 5point at Visit 2 (Randomized Visit) * Acute bronchitis within 48hr based on Visit 2 (Randomized Visit) * Those who can comply with the requirements of clinical trials * Written consent voluntarily to participate in this clinical trial
Exclusion criteria
* Patients who investigators determines to severe respiratory disease that would interfere with study assessment * Patients with systemic infections requiring systemic antibiotic therapy * patient with hemostatic disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bronchitis Severity Score(BSS) | Day 4 |
Countries
South Korea
Outcome results
None listed