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Completed

NCT Number: NCT07061925

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

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

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Key information

Conditions

Acute Bronchitis Bronchial Diseases Bronchitis Infections Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Konkuk University Medical Center

Seoul, 05030, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

ALC-2203-1

Drug

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

ALC-2203-2

Drug

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

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.

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.

Primary outcomes

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

    Time frame: Baseline (Day 0) to 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.

Secondary outcomes

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

    Time frame: Baseline (Day 0) to Day 4

    The secondary outcome measure is the change in total Bronchitis Severity Score (BSS) from baseline (Day 0) to Day 4 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.

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

    Time frame: Baseline (Day 0) to Day 4 and Day 7

    Change in the individual symptom scores of BSS (cough, sputum, rales/rhonchi, chest pain during coughing, and dyspnea) from baseline (Day 0) to Day 4 and 7

  3. Response rate based on BSS at Day 4 and Day 7

    Time frame: Baseline (Day 0) to Day 4 and Day 7

    The proportion of participants who show a total BSS score <3 or a reduction of ≥7 points from baseline at Day 4 and Day 7

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

    Time frame: Day 4 and Day 7

    Evaluation of the participant's overall improvement by the investigator using the Integrative Medicine Outcome Scale (IMOS). Treatment effectiveness is defined as an IMOS score of 4 ("major improvement") or 5 ("complete recovery")

  5. Participant-reported overall satisfaction and satisfaction rate at Days 4 and 7

    Time frame: Day 4 and Day 7

    Participant-reported overall satisfaction assessed using the Integrative Medicine Patient Satisfaction Scale (IMPSS). Satisfaction is defined as an IMPSS score of 4 ("satisfied") or 5 ("very satisfied")

  6. Change from baseline in COAT total score at Day 4 and Day 7

    Time frame: Baseline (Day 0) to Day 4 and Day 7

    Change in total score of the Cough Assessment Test (COAT), a participant-rated questionnaire assessing cough frequency, interference with daily life, sleep disturbance, fatigue, and hypersensitivity, each scored from 0 to 4 (total score: 0-20

Sponsors and collaborators

Lead sponsor

Korea Arlico Pharm. Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 14, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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