A Clinical Trial to Evaluate the Safety and Efficacy of "AG1904" in Acute Bronchitis
Phase 3
Completed
- Conditions
- Acute Bronchitis
- Interventions
- Drug: AGS (Experimental)Drug: AGU (Active Comparator)
- Registration Number
- NCT05344638
- Lead Sponsor
- Ahn-Gook Pharmaceuticals Co.,Ltd
- Brief Summary
A Multicenter, Randomized, Double-Blind, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of AGS Compared to AGU for Acute Bronchitis
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 220
Inclusion Criteria
- Both gender, 19 years ≤ age ≤ 75 years
- BSS(Bronchitis Severity Score) ≥ 5point at Visit 2 (Randomized Visit)
- Patients without fever 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 with respiratory and systemic infections requiring systemic antibiotic therapy
- Patients with bleeding tendency or coagulation disorder
- Patients who investigators determines to severe respiratory disease that would interfere with study assessment
- Those who have participated in other clinical trials within 4 weeks before participating in clinical trials
- In case the investigator judges that it is not suitable for the subject of this clinical trial for other reasons
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AGS (Experimental) AGS (Experimental) AGS + Placebo of AGU AGU (Active Comparator) AGU (Active Comparator) Placebo of AGS + AGU
- Primary Outcome Measures
Name Time Method Bronchitis Severity Total Score(BSS) change of Visit 3 compared to Visit 2 Visit 1 (-3 day), Visit 2 (0 day), Visit 3 (7 day) The BSS comprises the following five symptoms typical for Acute Bronchitis: cough, sputum, rales/rhonchi on auscultation, chest pain during coughing, and dyspnea. These symptoms are each assessed according to a 5-point scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe
- Secondary Outcome Measures
Name Time Method Individual symptom score of Bronchitis Severity Score(BSS) of Visit 3 compared to Visit 2 7days Treatment response rate at Visit 3 7days Integrative Medicine Outcome Scale (IMOS) 7days Integrative Medicine Patient Satisfaction Scale (IMPSS) 7days
Trial Locations
- Locations (1)
Konkuk University Medical Center
🇰🇷Seoul, Korea, Republic of