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

NCT07061925 | Completed Phase 2

• 1 other identifier: ALC-2203-201
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Bronchitis

Keywords

ALC-2203

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Bronchitis Severity Score (BSS) at Day 7

  The primary outcome measure is the change in total Bronchitis Severity Score (BSS) from baseline (Day 0) to Day 7 following administration of the investigational product. The BSS is a clinician-assessed tool used to evaluate five symptoms: cough, sputum, rales/rhonchi, chest pain during coughing, and dyspnea. Each symptom is scored on a scale from 0 to 4, yielding a total score ranging from 0 to 20.

  Baseline (Day 0) to Day 7

Secondary Outcomes (6)

• Change from baseline in Bronchitis Severity Score (BSS) at Day 4

  Baseline (Day 0) to Day 4

• Change from baseline in individual BSS symptom scores at Day 4 and 7

  Baseline (Day 0) to Day 4 and Day 7

• Response rate based on BSS at Day 4 and Day 7

  Baseline (Day 0) to Day 4 and Day 7

• Investigator-assessed overall improvement and treatment effectiveness at Day 4 and 7

  Day 4 and Day 7

• Participant-reported overall satisfaction and satisfaction rate at Days 4 and 7

  Day 4 and Day 7

Study Arms (4)

Experimental Group 1

EXPERIMENTAL

Drug: ALC-2203-1

Experimental Group 2

EXPERIMENTAL

Drug: ALC-2203-2

Active Comparator Group

ACTIVE COMPARATOR

Drug: ALC-2203-AC

Placebo Comparator Group

PLACEBO COMPARATOR

Drug: Placabo

Interventions

ALC-2203-1 DRUG

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

Experimental Group 1

ALC-2203-2 DRUG

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

Experimental Group 2

ALC-2203-AC 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.

Active Comparator Group

Placabo 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.

Placebo Comparator Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female participants aged 19 years or older.
• 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.
• Onset of acute bronchitis symptoms within 48 hours prior to Visit 2.
• Patients who voluntarily agree to participate

You may not qualify if:

• Patients who, in the opinion of the investigator, have severe respiratory diseases such as allergic asthma, chronic bronchitis, or asthma
• 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
• Patients who have participated in another clinical trial within 4 weeks prior to screening

Sponsors & Collaborators

• Korea Arlico Pharm. Co., Ltd: lead

Study Sites (1)

Konkuk University Medical Center

Seoul, 05030, South Korea

Location

MeSH Terms

Conditions

Bronchitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 14, 2025
• Study Start: April 23, 2025
• Primary Completion: November 21, 2025
• Study Completion: November 26, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)