Clinical Trial to Evaluate the Efficacy and Safety of YHP2401 Compared to YHR2402 and YHR2403 for Acute Bronchitis
- Conditions
- Acute Bronchitis
- Interventions
- Registration Number
- NCT07111468
- Lead Sponsor
- Yuhan Corporation
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 279
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description YHP2401 YHP2401 - YHR2402 YHR2402 - YHR2403 YHR2403 -
- Primary Outcome Measures
Name Time Method Bronchitis Severity Score(BSS) Day 4
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
Soonchunhyang University Hospital Bucheon
🇰🇷Bucheon, Korea, Republic of
Hallym University Chuncheon Sacred Heart Hospital
🇰🇷Chuncheon, Korea, Republic of
Wonkwang University Hospital
🇰🇷Iksan, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Eunpyeong St.Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Konkuk University Medical Center
🇰🇷Seoul, Korea, Republic of
Kangdong Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
SMG-SNU Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
🇰🇷Uijeongbu, Korea, Republic of
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