Clinical Trial to Evaluate the Efficacy and Safety of 'DW1601' in Acute Bronchitis

Daewon Pharmaceutical

Status and phase: Unknown; Phase 3

Conditions: Acute Bronchitis

Treatments: Drug: DW1601; Drug: DW16011; Drug: DW16012

Study type: Interventional

Funder types: Industry

Identifiers

NCT04260555

DW1601-301

Details and patient eligibility

About

A Multicenter, Randomized, Double-Blind, Parallel, Active-controlled, Superiority, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW1601 Compared to DW16011 and DW16012 for Acute Bronchitis

Enrollment: 204 estimated patients

Sex: All

Ages: 19 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Both gender, 19 years ≤ age ≤ 80 years
• Bronchitis Severity Score* ≥ 5point at Visit 2 (Randomized Visit)
• Acute bronchitis within 48hr 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 who investigators determines to severe respiratory disease that would interfere with study assessment
• Patients with systemic infections requiring systemic antibiotic therapy
• patient with hemostatic disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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204 participants in 3 patient groups

TEST

Experimental group

Description:

tid PO, DW1601 20ml + Placebo of DW16011 20ml + Placebo of DW16012 9ml

Treatment:

Drug: DW1601

Reference 1

Active Comparator group

Description:

tid PO, Placebo of DW1601 20ml + DW16011 20ml + Placebo of DW16012 9ml

Treatment:

Drug: DW16011

Reference 2

Active Comparator group

Description:

tid PO, Placebo of DW1601 20ml + Placebo of DW16011 20ml + DW16012 9ml

Treatment:

Drug: DW16012