A Clinical Trial to Evaluate the Safety and Efficacy of "AG1904" in Acute Bronchitis
Study Details
Study Description
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
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: AGS (Experimental) AGS + Placebo of AGU |
Drug: AGS (Experimental)
tid
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Active Comparator: AGU (Active Comparator) Placebo of AGS + AGU |
Drug: AGU (Active Comparator)
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|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Both gender, 19 years ≤ age ≤ 75 years
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BSS(Bronchitis Severity Score) ≥ 5point at Visit 2 (Randomized Visit)
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Patients without fever based on Visit 2(Randomized Visit)
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Those who can comply with the requirements of clinical trials
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Written consent voluntarily to participate in this clinical trial
Exclusion Criteria:
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Patients with respiratory and systemic infections requiring systemic antibiotic therapy
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Patients with bleeding tendency or coagulation disorder
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Patients who investigators determines to severe respiratory disease that would interfere with study assessment
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Those who have participated in other clinical trials within 4 weeks before participating in clinical trials
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In case the investigator judges that it is not suitable for the subject of this clinical trial for other reasons
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Konkuk University Medical Center | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Ahn-Gook Pharmaceuticals Co.,Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AG1904