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

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

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 Overview

• Status: Completed
• Conditions: Acute Bronchitis
• Intervention / Treatment: Drug: AGS (Experimental); Drug: AGU (Active Comparator)

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Konkuk University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AGS (Experimental); AGS + Placebo of AGU	Drug: AGS (Experimental); tid
Active Comparator: AGU (Active Comparator); Placebo of AGS + AGU	Drug: AGU (Active Comparator); tid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2019
• Primary Completion (Actual): July 29, 2020
• Study Completion (Actual): July 29, 2020

Study Registration Dates

• First Submitted: April 19, 2022
• First Submitted That Met QC Criteria: April 19, 2022
• First Posted (Actual): April 25, 2022

Study Record Updates

• Last Update Posted (Actual): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Bronchial Diseases; Lung Diseases, Obstructive; Acute Disease; Bronchitis
• Other Study ID Numbers: AG1904

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No