Back to resultsA Clinical Trial to Evaluate the Safety and Efficacy of "AG1904" in Acute Bronchitis
Primary Purpose
Acute Bronchitis
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
AGS (Experimental)
AGU (Active Comparator)
Sponsored by
About this trial
This is an interventional treatment trial for Acute Bronchitis
Eligibility Criteria
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
Sites / Locations
- Konkuk University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
AGS (Experimental)
AGU (Active Comparator)
Arm Description
AGS + Placebo of AGU
Placebo of AGS + AGU
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Individual symptom score of Bronchitis Severity Score(BSS) of Visit 3 compared to Visit 2
Treatment response rate at Visit 3
Integrative Medicine Outcome Scale (IMOS)
Integrative Medicine Patient Satisfaction Scale (IMPSS)
Full Information
NCT ID
NCT05344638
First Posted
April 19, 2022
Last Updated
April 19, 2022
Sponsor
Ahn-Gook Pharmaceuticals Co.,Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05344638
Brief Title
A Clinical Trial to Evaluate the Safety and Efficacy of "AG1904" in Acute Bronchitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 17, 2019 (Actual)
Primary Completion Date
July 29, 2020 (Actual)
Study Completion Date
July 29, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ahn-Gook Pharmaceuticals Co.,Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Bronchitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AGS (Experimental)
Arm Type
Experimental
Arm Description
AGS + Placebo of AGU
Arm Title
AGU (Active Comparator)
Arm Type
Active Comparator
Arm Description
Placebo of AGS + AGU
Intervention Type
Drug
Intervention Name(s)
AGS (Experimental)
Intervention Description
tid
Intervention Type
Drug
Intervention Name(s)
AGU (Active Comparator)
Intervention Description
tid
Primary Outcome Measure Information:
Title
Bronchitis Severity Total Score(BSS) change of Visit 3 compared to Visit 2
Description
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
Time Frame
Visit 1 (-3 day), Visit 2 (0 day), Visit 3 (7 day)
Secondary Outcome Measure Information:
Title
Individual symptom score of Bronchitis Severity Score(BSS) of Visit 3 compared to Visit 2
Time Frame
7days
Title
Treatment response rate at Visit 3
Time Frame
7days
Title
Integrative Medicine Outcome Scale (IMOS)
Time Frame
7days
Title
Integrative Medicine Patient Satisfaction Scale (IMPSS)
Time Frame
7days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Konkuk University Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Clinical Trial to Evaluate the Safety and Efficacy of "AG1904" in Acute Bronchitis
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