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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group 1 | Experimental |
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| Experimental Group 2 | Experimental |
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| Active Comparator Group | Active Comparator |
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| Placebo Comparator Group | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALC-2203-1 | Drug | This group receives ALC-2203-1 and a placebo matching ALC-2203-AC, administered three times daily for 7 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Male and female participants aged 19 years or older.
Patients diagnosed with acute bronchitis with:
Onset of acute bronchitis symptoms within 48 hours prior to Visit 2.
Patients who voluntarily agree to participate
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Konkuk University Medical Center | Seoul | 05030 | South Korea |
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| ID | Term |
|---|---|
| D001991 | Bronchitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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| ALC-2203-2 | Drug | This group receives ALC-2203-2 and a placebo matching ALC-2203-AC, administered three times daily for 7 days. |
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| 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. |
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| 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. |
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| 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 | 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 | 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") | 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") | 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 | Baseline (Day 0) to Day 4 and Day 7 |
| D008173 |
| Lung Diseases, Obstructive |
| D008171 | Lung Diseases |