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

NCT ID: NCT07061925

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

169 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-23

Study Completion Date

2025-11-26

Brief Summary

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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

Detailed Description

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Conditions

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Acute Bronchitis

Keywords

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ALC-2203

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental Group 1

Group Type EXPERIMENTAL

ALC-2203-1

Intervention Type DRUG

This group receives ALC-2203-1 and a placebo matching ALC-2203-AC, administered three times daily for 7 days.

Experimental Group 2

Group Type EXPERIMENTAL

ALC-2203-2

Intervention Type DRUG

This group receives ALC-2203-2 and a placebo matching ALC-2203-AC, administered three times daily for 7 days.

Active Comparator Group

Group Type ACTIVE_COMPARATOR

ALC-2203-AC

Intervention Type DRUG

This group receives a placebo matching ALC-2203-1 or ALC-2203-2, and ALC-2203-AC, administered three times daily for 7 days.

Placebo Comparator Group

Group Type PLACEBO_COMPARATOR

Placabo

Intervention Type DRUG

This group receives a placebo matching ALC-2203-1 or ALC-2203-2, and a placebo matching ALC-2203-AC, administered three times daily for 7 days.

Interventions

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ALC-2203-1

This group receives ALC-2203-1 and a placebo matching ALC-2203-AC, administered three times daily for 7 days.

Intervention Type DRUG

ALC-2203-2

This group receives ALC-2203-2 and a placebo matching ALC-2203-AC, administered three times daily for 7 days.

Intervention Type DRUG

ALC-2203-AC

This group receives a placebo matching ALC-2203-1 or ALC-2203-2, and ALC-2203-AC, administered three times daily for 7 days.

Intervention Type DRUG

Placabo

This group receives a placebo matching ALC-2203-1 or ALC-2203-2, and a placebo matching ALC-2203-AC, administered three times daily for 7 days.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea Arlico Pharm. Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Konkuk University Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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ALC-2203-201

Identifier Type: -

Identifier Source: org_study_id