To Evaluate the Efficacy and Safety of ALC-2203 in Patients With Acute Bronchitis

Korea Arlico Pharm. Co., Ltd

Status and phase: Completed; Phase 2

Conditions: Acute Bronchitis

Treatments: Drug: ALC-2203-AC; Drug: ALC-2203-2; Drug: ALC-2203-1; Drug: Placabo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07061925

ALC-2203-201

Details and patient eligibility

About

A Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter, Dose-finding, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of ALC-2203 in Patients with Acute Bronchitis

Enrollment: 169 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male and female participants aged 19 years or older.

2. Patients diagnosed with acute bronchitis with:

   • A Bronchitis Severity Score (BSS) of ≥ 5 at Visit 2.
   • A sputum subscore of at least 1 at Visit 2.

3. Onset of acute bronchitis symptoms within 48 hours prior to Visit 2.

4. Patients who voluntarily agree to participate

Exclusion criteria

1. Patients who, in the opinion of the investigator, have severe respiratory diseases such as allergic asthma, chronic bronchitis, or asthma
2. Patients who are currently taking, or are expected to take during the study period, antitussive or expectorant medications containing agents such as codeine or dextromethorphan
3. Patients who have participated in another clinical trial within 4 weeks prior to screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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169 participants in 4 patient groups, including a placebo group

Experimental Group 1

Experimental group

Treatment:

Drug: ALC-2203-1

Experimental Group 2

Experimental group

Treatment:

Drug: ALC-2203-2

Active Comparator Group

Active Comparator group

Treatment:

Drug: ALC-2203-AC

Placebo Comparator Group

Placebo Comparator group

Treatment:

Drug: Placabo