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

NCT05344638 | Completed Phase 3

• 1 other identifier: AG1904
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Bronchitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

AGS (Experimental)

EXPERIMENTAL

AGS + Placebo of AGU

Drug: AGS (Experimental)

AGU (Active Comparator)

ACTIVE COMPARATOR

Placebo of AGS + AGU

Drug: AGU (Active Comparator)

Interventions

AGS (Experimental) DRUG

tid

AGS (Experimental)

AGU (Active Comparator) DRUG

tid

AGU (Active Comparator)

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ahn-Gook Pharmaceuticals Co.,Ltd: lead

Study Sites (1)

Konkuk University Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Bronchitis

Interventions

Aspartylglucosylaminase

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: April 25, 2022
• Study Start: October 17, 2019
• Primary Completion: July 29, 2020
• Study Completion: July 29, 2020
• Last Updated: April 25, 2022

Record last verified: 2022-04

Locations

KR (1)