Acute Bronchitis
Conditions
Keywords
ALC-2203
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
Interventions
DRUGALC-2203-1
This group receives ALC-2203-1 and a placebo matching ALC-2203-AC, administered three times daily for 7 days.
DRUGALC-2203-2
This group receives ALC-2203-2 and a placebo matching ALC-2203-AC, administered three times daily for 7 days.
DRUGALC-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.
DRUGPlacabo
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.
Sponsors
Korea Arlico Pharm. Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Bronchitis Severity Score (BSS) at Day 7 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in individual BSS symptom scores at Day 4 and 7 | 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 |
| Response rate based on BSS at Day 4 and Day 7 | 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 |
| Change from baseline in Bronchitis Severity Score (BSS) at Day 4 | 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. |
| Participant-reported overall satisfaction and satisfaction rate at Days 4 and 7 | 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) |
| Change from baseline in COAT total score at Day 4 and Day 7 | 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 |
| Investigator-assessed overall improvement and treatment effectiveness at Day 4 and 7 | 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) |
Countries
South Korea
Outcome results
None listed