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NCT05344638 Clinical Trial

A Clinical Trial to Evaluate the Safety and Efficacy of "AG1904" in Acute Bronchitis

Acute Bronchitis Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05344638
Other study ID # AG1904
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 17, 2019
Est. completion date July 29, 2020

Study information
Verified date April 2022
Source Ahn-Gook Pharmaceuticals Co.,Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 220
Est. completion date July 29, 2020
Est. primary completion date July 29, 2020
Accepts healthy volunteers No
Gender All
Age group 19 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• AGS (Experimental)
tid
• AGU (Active Comparator)
tid

Locations
Country Name City State
Korea, Republic of Konkuk University Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Ahn-Gook Pharmaceuticals Co.,Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Bronchitis Severity Total Score(BSS) change of Visit 3 compared to Visit 2 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 Visit 1 (-3 day), Visit 2 (0 day), Visit 3 (7 day)
Secondary Individual symptom score of Bronchitis Severity Score(BSS) of Visit 3 compared to Visit 2 7days
Secondary Treatment response rate at Visit 3 7days
Secondary Integrative Medicine Outcome Scale (IMOS) 7days
Secondary Integrative Medicine Patient Satisfaction Scale (IMPSS) 7days
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