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

Ahn-Gook Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Acute Bronchitis

Treatments: Drug: AGS (Experimental); Drug: AGU (Active Comparator)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05344638

AG1904

Details and patient eligibility

About

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

Enrollment: 220 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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220 participants in 2 patient groups

AGS (Experimental)

Experimental group

Description:

AGS + Placebo of AGU

Treatment:

Drug: AGS (Experimental)

AGU (Active Comparator)

Active Comparator group

Description:

Placebo of AGS + AGU

Treatment:

Drug: AGU (Active Comparator)