Acute BronchitisPhase 3NCT07111468
Clinical Trial to Evaluate the Efficacy and Safety of YHP2401 Compared to YHR2402 and YHR2403 for Acute Bronchitis
A Phase 3 study testing YHP2401, YHR2402 and YHR2403 in people with Acute Bronchitis, run by Yuhan Corporation at 11 sites in South Korea.
Trial summary
A Multicenter, Randomized, Double-blind, Parallel, Active-controlled, Superiority, Phase III Clinical Trial to Evaluate the Efficacy and Safety of YHP2401 Compared to YHR2402 and YHR2403 for Acute Bronchitis Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Acute Bronchitis
- What is being tested?
- YHP2401, YHR2402 and YHR2403
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 11 sitesSouth Korea
- Study dates
- 19 Aug 2025to 26 Jan 2026
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female participants 19 years ≤ age ≤ 80 years
- Patients with acute bronchitis presenting with productive cough symptoms within 48 hours prior to Visit 2 (Baseline)
- BSS total score ≥ 5 at Visit 2, including Cough score ≥ 2, Sputum score ≥ 1
- Patients who voluntarily signed the consent form
Who cannot join
- Severe lung disease as determined by the investigator
- Clinically significant abnormal findings or signs on chest X-ray suggesting diagnoses other than acute bronchitis
- Active infection requiring systemic antibiotic treatment
- Patients who need to take contraindicated concomitant medications
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
South Korea11 sites
Soonchunhyang University Hospital Bucheon
Bucheon-si, 14584
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, 24253
Wonkwang University Hospital
Iksan, 54538
Kangbuk Samsung Hospital
Seoul, 03181
The Catholic University of Korea, Eunpyeong St.Mary's Hospital
Seoul, 03312
Konkuk University Medical Center
Seoul, 05030
Kangdong Sacred Heart Hospital
Seoul, 05355
SMG-SNU Boramae Medical Center
Seoul, 07061
Korea University Guro Hospital
Seoul, 08308
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
Uijeongbu-si, 11765
Ulsan University Hospital
Ulsan, 44033
About this study
Official title: A Multicenter, Randomized, Double-blind, Parallel, Active-controlled, Superiority, Phase III Clinical Trial to Evaluate the Efficacy and Safety of YHP2401 Compared to YHR2402 and YHR2403 for Acute Bronchitis
A Multicenter, Randomized, Double-blind, Parallel, Active-controlled, Superiority, Phase III Clinical Trial to Evaluate the Efficacy and Safety of YHP2401 Compared to YHR2402 and YHR2403 for Acute Bronchitis
- Conditions
- Acute Bronchitis
- Being tested
- YHP2401, YHR2402, YHR2403
- Medical subject headings
- Bronchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YHP2401Drug
Total 7 days of treatment and The daily dose is tid.(YHP2401 + Placebo of YHR2402 + Placebo of YHR2403)
YHR2402Drug
Total 7 days of treatment and The daily dose is tid.(Placebo of YHP2401 + YHR2402 + Placebo of YHR2403)
YHR2403Drug
Total 7 days of treatment and The daily dose is tid.(Placebo of YHP2401 + Placebo of YHR2402 + YHR2403)
| Study group | Role | What they receive |
|---|---|---|
| YHP2401 | Experimental | Not described Receives: Drug: YHP2401 |
| YHR2402 | Active comparator | Not described Receives: Drug: YHR2402 |
| YHR2403 | Active comparator | Not described Receives: Drug: YHR2403 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bronchitis Severity Score(BSS)
Measured: Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start19 Aug 2025
- Primary completion15 Jan 2026
- Study completion26 Jan 2026
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.
- More trials run by Yuhan CorporationThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07111468
- Sponsor's protocol ID
- YHP2401-301
- Status last verified
- Feb 2026
- First submitted
- 1 Aug 2025
- Last updated
- 9 Feb 2026
- 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 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Parallel, Active-controlled, Superiority, Phase III Clinical Trial to Evaluate the Efficacy and Safety of YHP2401 Compared to YHR2402 and YHR2403 for Acute Bronchitis
- ClinicalTrials.gov ID
- NCT07111468
- Acronym / sponsor ID
- YHP2401-301
- Conditions
- Acute Bronchitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 19 Aug 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 26 Jan 2026 (actual)
- First posted
- 8 Aug 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 Multicenter, Randomized, Double-blind, Parallel, Active-controlled, Superiority, Phase III Clinical Trial to Evaluate the Efficacy and Safety of YHP2401 Compared to YHR2402 and YHR2403 for Acute Bronchitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| YHP2401 | Experimental | Drug: YHP2401 |
| YHR2402 | Active comparator | Drug: YHR2402 |
| YHR2403 | Active comparator | Drug: YHR2403 |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female participants 19 years ≤ age ≤ 80 years
- Patients with acute bronchitis presenting with productive cough symptoms within 48 hours prior to Visit 2 (Baseline)
- BSS total score ≥ 5 at Visit 2, including Cough score ≥ 2, Sputum score ≥ 1
- Patients who voluntarily signed the consent form
Key exclusion criteria (4 listed)
- Severe lung disease as determined by the investigator
- Clinically significant abnormal findings or signs on chest X-ray suggesting diagnoses other than acute bronchitis
- Active infection requiring systemic antibiotic treatment
- Patients who need to take contraindicated concomitant medications
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 |
|---|---|---|
| YHP2401Total 7 days of treatment and The daily dose is tid.(YHP2401 + Placebo of YHR2402 + Placebo of YHR2403) | Drug | YHP2401 |
| YHR2402Total 7 days of treatment and The daily dose is tid.(Placebo of YHP2401 + YHR2402 + Placebo of YHR2403) | Drug | YHR2402 |
| YHR2403Total 7 days of treatment and The daily dose is tid.(Placebo of YHP2401 + Placebo of YHR2402 + YHR2403) | Drug | YHR2403 |
Primary outcome
Bronchitis Severity Score(BSS)
Time frame: Day 4
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 9 Feb 2026.
- 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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing YHP2401, YHR2402 and YHR2403 in people with Acute Bronchitis, run by Yuhan Corporation at 11 sites 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 4 inclusion and 4 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 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Bronchitis Severity Score(BSS) (time frame: Day 4). 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 9 Feb 2026.