Acute BronchitisPhase 2NCT07061925
To Evaluate the Efficacy and Safety of ALC-2203 in Patients With Acute Bronchitis
A Phase 2 study testing ALC-2203-1, ALC-2203-2 and ALC-2203-AC in people with Acute Bronchitis, run by Korea Arlico Pharm. Co., Ltd at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Bronchitis
- What is being tested?
- ALC-2203-1, ALC-2203-2 and ALC-2203-AC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 169 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Apr 2025to 26 Nov 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- ALC-2203-1, ALC-2203-2, ALC-2203-AC, Placabo
- Keywords
- ALC-2203
- Medical subject headings
- Bronchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALC-2203-1Drug
This group receives ALC-2203-1 and a placebo matching ALC-2203-AC, administered three times daily for 7 days.
ALC-2203-2Drug
This group receives ALC-2203-2 and a placebo matching ALC-2203-AC, administered three times daily for 7 days.
ALC-2203-ACDrug
This group receives a placebo matching ALC-2203-1 or ALC-2203-2, and ALC-2203-AC, administered three times daily for 7 days.
PlacaboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group 1 | Experimental | Not described Receives: Drug: ALC-2203-1 |
| Experimental Group 2 | Experimental | Not described Receives: Drug: ALC-2203-2 |
| Active Comparator Group | Active comparator | Not described Receives: Drug: ALC-2203-AC |
| Placebo Comparator Group | Placebo comparator | Not described Receives: Drug: Placabo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 0) to Day 7
Secondary outcomes (6)
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.
Measured: 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
Measured: 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
Measured: 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")
Measured: 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")
Measured: 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
Measured: Baseline (Day 0) to Day 4 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start23 Apr 2025
- Primary completion21 Nov 2025
- Study completion26 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute BronchitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea Arlico Pharm. Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061925
- Sponsor's protocol ID
- ALC-2203-201
- Status last verified
- Dec 2025
- First submitted
- 27 Jun 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07061925
- Acronym / sponsor ID
- ALC-2203-201
- Conditions
- Acute Bronchitis
- Keywords
- ALC-2203
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Korea Arlico Pharm. Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 23 Apr 2025 (actual)
- Primary completion
- 21 Nov 2025 (actual)
- Study completion
- 26 Nov 2025 (actual)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALC-2203-1This group receives ALC-2203-1 and a placebo matching ALC-2203-AC, administered three times daily for 7 days. | Drug | Experimental Group 1 |
| ALC-2203-2This group receives ALC-2203-2 and a placebo matching ALC-2203-AC, administered three times daily for 7 days. | Drug | Experimental Group 2 |
| ALC-2203-ACThis group receives a placebo matching ALC-2203-1 or ALC-2203-2, and ALC-2203-AC, administered three times daily for 7 days. | Drug | Active Comparator Group |
| PlacaboThis 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. | Drug | Placebo Comparator Group |
Primary outcome
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.
6 secondary outcomes
Change from baseline in Bronchitis Severity Score (BSS) at Day 4
Time frame: Baseline (Day 0) to Day 4
Change from baseline in individual BSS symptom scores at 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
Time frame: Baseline (Day 0) to Day 4 and Day 7
Investigator-assessed overall improvement and treatment effectiveness at Day 4 and 7
Time frame: Day 4 and Day 7
Participant-reported overall satisfaction and satisfaction rate at Days 4 and 7
Time frame: Day 4 and Day 7
Change from baseline in COAT total score at Day 4 and Day 7
Time frame: Baseline (Day 0) to Day 4 and Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALC-2203-1, ALC-2203-2 and ALC-2203-AC in people with Acute Bronchitis, run by Korea Arlico Pharm. Co., Ltd at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Bronchitis Severity Score (BSS) at Day 7 (time frame: Baseline (Day 0) to Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.