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

Ahn-Gook Pharmaceuticals Co.,Ltd220 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

220

Conditions

Acute Bronchitis

Interventions

AGS (Experimental)DRUG

tid

AGU (Active Comparator)DRUG

tid

Eligibility

Sex: ALLMin age: 19 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Konkuk University Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

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

Time frame: Visit 1 (-3 day), Visit 2 (0 day), Visit 3 (7 day)

Secondary Outcomes

Individual symptom score of Bronchitis Severity Score(BSS) of Visit 3 compared to Visit 2

Time frame: 7days

Treatment response rate at Visit 3

Time frame: 7days

Integrative Medicine Outcome Scale (IMOS)

Time frame: 7days

Integrative Medicine Patient Satisfaction Scale (IMPSS)

Time frame: 7days

Data from ClinicalTrials.gov

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