A Phase 2 interventional study of ALC-2203-1 and ALC-2203-2 in Acute Bronchitis, sponsored by Korea Arlico Pharm. Co., Ltd. Completed at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-12-24.
Sponsored by Korea Arlico Pharm. Co., Ltd · Phase 2, Interventional, and Treatment
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
Patients diagnosed with acute bronchitis with:
Exclusion Criteria:
Drug: ALC-2203-1
Drug: ALC-2203-2
Drug: ALC-2203-AC
Drug: Placabo
This group receives ALC-2203-1 and a placebo matching ALC-2203-AC, administered three times daily for 7 days.
This group receives ALC-2203-2 and a placebo matching ALC-2203-AC, administered three times daily for 7 days.
This group receives a placebo matching ALC-2203-1 or ALC-2203-2, and ALC-2203-AC, administered three times daily for 7 days.
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.
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.
Time frame: Baseline (Day 0) to Day 7
Change from baseline in Bronchitis Severity Score (BSS) at 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.
Time frame: Baseline (Day 0) to Day 4
Change from baseline in individual BSS symptom scores at Day 4 and 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
Time frame: Baseline (Day 0) to Day 4 and Day 7
Response rate based on BSS at 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
Time frame: Baseline (Day 0) to Day 4 and Day 7
Investigator-assessed overall improvement and treatment effectiveness at Day 4 and 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")
Time frame: Day 4 and Day 7
Participant-reported overall satisfaction and satisfaction rate at Days 4 and 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")
Time frame: Day 4 and Day 7
Change from baseline in COAT total score at 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
Time frame: Baseline (Day 0) to Day 4 and Day 7
Plan to share: No
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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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