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 YHP2401 Compared to YHR2402 and YHR2403 for Acute Bronchitis
Interventions
DRUGYHP2401
Total 7 days of treatment and The daily dose is tid.(YHP2401 + Placebo of YHR2402 + Placebo of YHR2403)
DRUGYHR2402
Total 7 days of treatment and The daily dose is tid.(Placebo of YHP2401 + YHR2402 + Placebo of YHR2403)
DRUGYHR2403
Total 7 days of treatment and The daily dose is tid.(Placebo of YHP2401 + Placebo of YHR2402 + YHR2403)
Sponsors
Yuhan Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male and female participants 19 years ≤ age ≤ 80 years * Patients with acute bronchitis presenting with productive cough symptoms within 48 hours prior to Visit 2 (Baseline) * BSS total score ≥ 5 at Visit 2, including Cough score ≥ 2, Sputum score ≥ 1 * Patients who voluntarily signed the consent form
Exclusion criteria
* Severe lung disease as determined by the investigator * Clinically significant abnormal findings or signs on chest X-ray suggesting diagnoses other than acute bronchitis * Active infection requiring systemic antibiotic treatment * Patients who need to take contraindicated concomitant medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bronchitis Severity Score(BSS) | Day 4 |
Countries
South Korea
Outcome results
None listed