Acute BronchitisPhase 4NCT07835620
A Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of CANIUM Tab. in Acute Bronchitis Patients.
A Phase 4 study testing DSP2505(Canium) and Umckamin in people with Acute Bronchitis, run by Dasan Pharmaceutical Co., Ltd. at 12 sites in South Korea.
Trial summary
This study compared two oral medicines containing Pelargonium sidoides extract in patients aged 12 to 75 years with acute bronchitis. Participants were randomly assigned to DSP2505 (Ckanium tablets) or Umckamin tablets for 7 days. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Acute Bronchitis
- What is being tested?
- DSP2505(Canium) and Umckamin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 223 participants
- Where
- 12 sitesSouth Korea
- Study dates
- 26 Jan 2026to 9 Sep 2026
- Phase
- Phase 4
- 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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female patients aged 12 to 75 years, inclusive.
- Acute bronchitis with onset within 48 hours before randomization and BSS total score >=5 at both screening and randomization.
- Females of childbearing potential and males agree to medically acceptable contraception during the trial: ovulation-inhibiting combined hormonal contraception (oral, intravaginal, or transdermal); ovulation-inhibiting progestogen-only contraception (oral, injectable, or implantable); intrauterine device; intrauterine hormone-releasing system; bilateral tubal ligation/salpingectomy; bilateral oophorectomy; vasectomized partner; or sexual abstinence.
- Negative pregnancy test before study medication in females of childbearing potential.
- Voluntary written informed consent after explanation of the study. A legally authorized representative also provides written consent for participants younger than 19 years.
Who cannot join
- Body temperature >38.5 degrees Celsius at randomization.
- Respiratory disease that could affect efficacy assessment, including pneumonia, bronchial asthma, cystic fibrosis, viral influenza, active tuberculosis, chronic obstructive pulmonary disease, bronchiectasis, or interstitial lung disease; or suspected pneumonia on chest radiography, auscultation, or vital signs.
- Medical history or disease judged to affect the study, including a coagulation disorder, increased bleeding tendency, or abnormal coagulation test at screening; malignancy within 5 years (exceptions include completely excised basal/squamous cell carcinoma, radically resected papillary thyroid carcinoma, or successfully treated cervical carcinoma in situ at least 1 year previously; patients considered cured within the previous 5 years with no subsequent treatment or anticipated need for treatment may participate); or clinically significant hepatic, renal, cardiovascular, respiratory, endocrine, or central nervous system disease or disorder.
- History of psychiatric illness, alcoholism, or drug abuse.
- Hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- Use or planned use of prohibited medication: anticoagulants at screening; systemic antibiotics/antivirals or systemic/inhaled glucocorticoids from 2 weeks before randomization through the final visit; ACE inhibitors from 1 week before randomization (4 weeks for perindopril) through the final visit, except stable dosing for an underlying condition; expectorants, mucolytics, antitussives, or herbal antitussive/expectorant products from 2 days before randomization through the final visit; or antihistamines, anticholinergics including bronchodilators, other symptomatic treatments for acute bronchitis, or analgesics throughout the study. Temporary acetaminophen for fever up to 1.5 g/day is permitted, except within 24 hours before Visits 2 and 3.
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- ALT or AST >3 times the upper limit of normal, or estimated glomerular filtration rate <30 mL/min/1.73 m2 calculated using the CKD-EPI equation.
- History of hypersensitivity to study medication ingredients.
- Pregnancy or breastfeeding.
- Average smoking of at least 15 cigarettes/day during the preceding 30 days.
- Receipt of investigational medication or an investigational device in another trial within 30 days before screening, or current participation in another interventional trial.
- Any other reason judged by the investigator to make participation inappropriate.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
South Korea12 sites
Hallym University Sacred Heart Hospital
Anyang
Dong-A University Hospital
Busan
Inje University Haeundae Paik Hospital
Busan
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon
Wonkwang University Hospital
Iksan
Incheon St. Mary's Hospital, The Catholic University of Korea
Incheon
Eunpyeong St. Mary's Hospital, The Catholic University of Korea
Seoul
Hallym University Kangnam Sacred Heart Hospital
Seoul
Konkuk University Medical Center
Seoul
Yeouido St. Mary's Hospital, The Catholic University of Korea
Seoul
Ulsan University Hospital
Ulsan
Pusan National University Yangsan Hospital
Yangsan
About this study
Official title: A Multi-center, Randomized, Double-blind, Active Control, Parallel, Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of CANIUM Tab. in Acute Bronchitis Patients.
This study compared two oral medicines containing Pelargonium sidoides extract in patients aged 12 to 75 years with acute bronchitis. Participants were randomly assigned to DSP2505 (Ckanium tablets) or Umckamin tablets for 7 days. The main question was whether DSP2505 was no worse than Umckamin by more than a defined margin in improving bronchitis symptoms. Symptoms, cough-related quality of life, overall improvement, satisfaction, and safety were assessed.
Read the detailed description
This phase 4, multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group non-inferiority trial was conducted at 12 hospitals in the Republic of Korea. Eligible patients had acute bronchitis with onset within 48 hours before randomization and a Bronchitis Severity Score (BSS) of at least 5 at screening and baseline. Following a screening period of up to 2 days, participants were randomized 1:1 to DSP2505 or Umckamin for 7 days. Randomization was stratified by baseline BSS (<8 or >=8). Matching placebos maintained blinding. Assessments were performed at baseline and the Day 7 end-of-treatment visit.
The primary endpoint was change in BSS total score from baseline to Day 7. The clinical study report describes an analysis of covariance with treatment as a fixed effect and baseline BSS as a covariate. Non-inferiority was assessed by comparing the upper bound of the two-sided 95% confidence interval for the adjusted difference (DSP2505 minus Umckamin) with a margin of 1.10 points. The per-protocol set was the primary efficacy analysis population, with a supporting full-analysis-set analysis. Safety was assessed in participants who received at least one dose.
This registration was prepared after study completion and analysis of the results.
- Conditions
- Acute Bronchitis
- Being tested
- DSP2505(Canium), Umckamin, Placebo Matching Umckamin, Placebo Matching DSP2505 (Canium)
- Keywords
- Pelargonium sidoides, Non-inferiority, Herbal medicine, DSP2505, BSS, COAT, Ckanium, Umckamin
- Medical subject headings
- Bronchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSP2505(Canium)Drug
Canium film-coated tablet containing 20 mg of Pelargonium sidoides 11% ethanol dry extract (5.5-6.6:1). One tablet orally three times daily for 7 days.
UmckaminDrug
Tablet containing 111.111 mg of Pelargonium sidoides 11% ethanol extract (1:8-10) and maltodextrin mixture (1:4.56), equivalent to 20 mg of dried extract. One tablet orally three times daily for 7 days.
Placebo Matching UmckaminDrug
One matching placebo tablet orally three times daily for 7 days to maintain double-dummy blinding.
Placebo Matching DSP2505 (Canium)Drug
One matching placebo tablet orally three times daily for 7 days to maintain double-dummy blinding.
| Study group | Role | What they receive |
|---|---|---|
| DSP2505 (Canium) | Experimental | DSP2505 (Canium) one tablet plus one matching placebo for Umckamin, orally three times daily for 7 days. Receives: Drug: DSP2505(Canium); Drug: Placebo Matching Umckamin |
| Umckamin | Active comparator | Umckamin one tablet plus one matching placebo for DSP2505, orally three times daily for 7 days. Receives: Drug: Umckamin; Drug: Placebo Matching DSP2505 (Canium) |
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) Total Score at Day 7
BSS is the sum of five symptom scores: cough, sputum, rales/rhonchi, chest pain during coughing, and dyspnea. Each is rated from 0 (absent) to 4 (very severe), giving a total of 0 to 20. Higher scores indicate greater symptom severity. Change is Day 7 minus baseline; a negative change indicates improvement.
Measured: Baseline and Day 7
Secondary outcomes (18)
Change From Baseline in BSS Cough Score at Day 7
The cough component of BSS is rated from 0 (absent) to 4 (very severe). Change is Day 7 minus baseline; a negative change indicates improvement.
Measured: Baseline and Day 7
Change From Baseline in BSS Sputum Score at Day 7
The sputum component of BSS is rated from 0 (absent) to 4 (very severe). Change is Day 7 minus baseline; a negative change indicates improvement.
Measured: Baseline and Day 7
Change From Baseline in BSS Rales/Rhonchi Score at Day 7
The rales/rhonchi component of BSS is rated from 0 (absent) to 4 (very severe). Change is Day 7 minus baseline; a negative change indicates improvement.
Measured: Baseline and Day 7
Change From Baseline in BSS Chest Pain During Coughing Score at Day 7
The chest pain during coughing component of BSS is rated from 0 (absent) to 4 (very severe). Change is Day 7 minus baseline; a negative change indicates improvement.
Measured: Baseline and Day 7
Change From Baseline in BSS Dyspnea Score at Day 7
The dyspnea component of BSS is rated from 0 (absent) to 4 (very severe). Change is Day 7 minus baseline; a negative change indicates improvement.
Measured: Baseline and Day 7
Percentage of Participants With BSS Total Score Below 3 at Day 7
Response defined as BSS total score <3 at Day 7.
Measured: Baseline and Day 7
Percentage of Participants With a BSS Total Score Reduction of at Least 7 Points
Response defined as a reduction in BSS total score of at least 7 points from baseline to Day 7.
Measured: Baseline and Day 7
Percentage of Participants Meeting Both BSS Response Criteria
Response defined as both a BSS total score <3 at Day 7 and a reduction of at least 7 points from baseline.
Measured: Baseline and Day 7
Change From Baseline in Cough Assessment Test (COAT) Total Score at Day 7
COAT assesses cough frequency, interference with daily activities, sleep disturbance, fatigue, and airway hypersensitivity. Each of five items is scored from 0 to 4, giving a total of 0 to 20. Higher scores indicate greater cough-related impairment. Change is Day 7 minus baseline; a negative change indicates improvement.
Measured: Baseline and Day 7
Investigator-rated Global Improvement at Day 7
The Integrative Medicine Outcome Scale (IMOS) rates change relative to baseline: 1=complete recovery, 2=major improvement, 3=slight to moderate improvement, 4=no change, and 5=deterioration. Lower scores indicate greater improvement. The distribution across the five categories is assessed.
Measured: Day 7
Percentage of Participants With Investigator-rated Global Improvement at Day 7
The Integrative Medicine Outcome Scale (IMOS) rates change relative to baseline: 1=complete recovery, 2=major improvement, 3=slight to moderate improvement, 4=no change, and 5=deterioration. Lower scores indicate greater improvement. Improvement is defined as an IMOS rating of 1 or 2 by the investigator.
Measured: Day 7
Percentage of Participants With Participant-rated Global Improvement at Day 7
The Integrative Medicine Outcome Scale (IMOS) rates change relative to baseline: 1=complete recovery, 2=major improvement, 3=slight to moderate improvement, 4=no change, and 5=deterioration. Lower scores indicate greater improvement. Improvement is defined as an IMOS rating of 1 or 2 by the participant.
Measured: Day 7
Participant Satisfaction With Treatment at Day 7
The Integrative Medicine Patient Satisfaction Scale (IMPSS) is a five-category participant rating: 1=very satisfied, 2=satisfied, 3=neutral, 4=dissatisfied, and 5=very dissatisfied. Lower scores indicate greater satisfaction. The distribution across categories is assessed.
Measured: Day 7
Number of Participants With Treatment-emergent Adverse Events
Participants experiencing adverse events arising after study medication administration, including serious adverse events, adverse drug reactions, and events leading to study discontinuation.
Measured: From first dose through the Day 7 end-of-treatment assessment
Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Tests
Clinically significant abnormalities in clinical laboratory tests are assessed by the investigator, including changes from normal or non-clinically significant findings before treatment to clinically significant abnormal findings after treatment.
Measured: Screening/before treatment and Day 7
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Clinically significant abnormalities in vital signs are assessed by the investigator, including changes from normal or non-clinically significant findings before treatment to clinically significant abnormal findings after treatment.
Measured: Screening/before treatment and Day 7
Number of Participants With Clinically Significant Abnormalities in Physical Examination
Clinically significant abnormalities in physical examination are assessed by the investigator, including changes from normal or non-clinically significant findings before treatment to clinically significant abnormal findings after treatment.
Measured: Screening/before treatment and Day 7
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram
Clinically significant abnormalities in electrocardiogram are assessed by the investigator, including changes from normal or non-clinically significant findings before treatment to clinically significant abnormal findings after treatment.
Measured: Screening/before treatment 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 posted23 Sep 2026
- Study start26 Jan 2026
- Primary completion21 Apr 2026
- Study completion9 Sep 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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel groups, assigned 1:1, with randomization stratified by baseline BSS (\<8 or \>=8). Double-dummy active-controlled non-inferiority comparison.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dasan Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Konkuk University Hospital, Dong-A University Hospital, Pusan National University Yangsan Hospital, Wonkwang University Hospital, InjeUniversityBusanPaikHospital, Hallym University Kangnam Sacred Heart Hospital, Hallym University Medical Center, Ulsan University Hospital, Yeouido St. Mary's Hospital, Incheon St.Mary's Hospital, Eunpyeong St. Mary's Hospital
- Responsible party
- Sponsor
- Investigators
- Kwang Ha Yoo, Study chair, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835620
- Sponsor's protocol ID
- DSP2505-CT4
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data will not be shared to protect participant confidentiality. Study findings will be disseminated through scientific publications reporting aggregate results.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Active Control, Parallel, Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of CANIUM Tab. in Acute Bronchitis Patients.
- ClinicalTrials.gov ID
- NCT07835620
- Acronym / sponsor ID
- DSP2505-CT4
- Conditions
- Acute Bronchitis
- Keywords
- Pelargonium sidoides, Non-inferiority, Herbal medicine, DSP2505, BSS, COAT, Ckanium, Umckamin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Dasan Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Konkuk University Hospital, Dong-A University Hospital, Pusan National University Yangsan Hospital, Wonkwang University Hospital, InjeUniversityBusanPaikHospital, Hallym University Kangnam Sacred Heart Hospital, Hallym University Medical Center, Ulsan University Hospital, Yeouido St. Mary's Hospital, Incheon St.Mary's Hospital, Eunpyeong St. Mary's Hospital
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- 21 Apr 2026 (actual)
- Study completion
- 9 Sep 2026 (actual)
- First posted
- 23 Sep 2026 (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.
This study compared two oral medicines containing Pelargonium sidoides extract in patients aged 12 to 75 years with acute bronchitis. Participants were randomly assigned to DSP2505 (Ckanium tablets) or Umckamin tablets for 7 days. The main question was whether DSP2505 was no worse than Umckamin by more than a defined margin in improving bronchitis symptoms. Symptoms, cough-related quality of life, overall improvement, satisfaction, and safety were assessed.
Detailed description
This phase 4, multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group non-inferiority trial was conducted at 12 hospitals in the Republic of Korea. Eligible patients had acute bronchitis with onset within 48 hours before randomization and a Bronchitis Severity Score (BSS) of at least 5 at screening and baseline. Following a screening period of up to 2 days, participants were randomized 1:1 to DSP2505 or Umckamin for 7 days. Randomization was stratified by baseline BSS (<8 or >=8). Matching placebos maintained blinding. Assessments were performed at baseline and the Day 7 end-of-treatment visit.
The primary endpoint was change in BSS total score from baseline to Day 7. The clinical study report describes an analysis of covariance with treatment as a fixed effect and baseline BSS as a covariate. Non-inferiority was assessed by comparing the upper bound of the two-sided 95% confidence interval for the adjusted difference (DSP2505 minus Umckamin) with a margin of 1.10 points. The per-protocol set was the primary efficacy analysis population, with a supporting full-analysis-set analysis. Safety was assessed in participants who received at least one dose.
This registration was prepared after study completion and analysis of the results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Two parallel groups, assigned 1:1, with randomization stratified by baseline BSS (<8 or >=8). Double-dummy active-controlled non-inferiority comparison.
| Arm | Type | Receives |
|---|---|---|
| DSP2505 (Canium) | Experimental | Drug: DSP2505(Canium), Drug: Placebo Matching UmckaminDSP2505 (Canium) one tablet plus one matching placebo for Umckamin, orally three times daily for 7 days. |
| Umckamin | Active comparator | Drug: Umckamin, Drug: Placebo Matching DSP2505 (Canium)Umckamin one tablet plus one matching placebo for DSP2505, orally three times daily for 7 days. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients aged 12 to 75 years, inclusive.
- Acute bronchitis with onset within 48 hours before randomization and BSS total score >=5 at both screening and randomization.
- Females of childbearing potential and males agree to medically acceptable contraception during the trial: ovulation-inhibiting combined hormonal contraception (oral, intravaginal, or transdermal); ovulation-inhibiting progestogen-only contraception (oral, injectable, or implantable); intrauterine device; intrauterine hormone-releasing system; bilateral tubal ligation/salpingectomy; bilateral oophorectomy; vasectomized partner; or sexual abstinence.
- Negative pregnancy test before study medication in females of childbearing potential.
- Voluntary written informed consent after explanation of the study. A legally authorized representative also provides written consent for participants younger than 19 years.
Key exclusion criteria (12 listed)
- Body temperature >38.5 degrees Celsius at randomization.
- Respiratory disease that could affect efficacy assessment, including pneumonia, bronchial asthma, cystic fibrosis, viral influenza, active tuberculosis, chronic obstructive pulmonary disease, bronchiectasis, or interstitial lung disease; or suspected pneumonia on chest radiography, auscultation, or vital signs.
- Medical history or disease judged to affect the study, including a coagulation disorder, increased bleeding tendency, or abnormal coagulation test at screening; malignancy within 5 years (exceptions include completely excised basal/squamous cell carcinoma, radically resected papillary thyroid carcinoma, or successfully treated cervical carcinoma in situ at least 1 year previously; patients considered cured within the previous 5 years with no subsequent treatment or anticipated need for treatment may participate); or clinically significant hepatic, renal, cardiovascular, respiratory, endocrine, or central nervous system disease or disorder.
- History of psychiatric illness, alcoholism, or drug abuse.
- Hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
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 |
|---|---|---|
| DSP2505(Canium)Canium film-coated tablet containing 20 mg of Pelargonium sidoides 11% ethanol dry extract (5.5-6.6:1). One tablet orally three times daily for 7 days. | Drug | DSP2505 (Canium) |
| UmckaminTablet containing 111.111 mg of Pelargonium sidoides 11% ethanol extract (1:8-10) and maltodextrin mixture (1:4.56), equivalent to 20 mg of dried extract. One tablet orally three times daily for 7 days. | Drug | Umckamin |
| Placebo Matching UmckaminOne matching placebo tablet orally three times daily for 7 days to maintain double-dummy blinding. | Drug | DSP2505 (Canium) |
| Placebo Matching DSP2505 (Canium)One matching placebo tablet orally three times daily for 7 days to maintain double-dummy blinding. | Drug | Umckamin |
Primary outcome
Change From Baseline in Bronchitis Severity Score (BSS) Total Score at Day 7
Time frame: Baseline and Day 7
BSS is the sum of five symptom scores: cough, sputum, rales/rhonchi, chest pain during coughing, and dyspnea. Each is rated from 0 (absent) to 4 (very severe), giving a total of 0 to 20. Higher scores indicate greater symptom severity. Change is Day 7 minus baseline; a negative change indicates improvement.
18 secondary outcomes
Change From Baseline in BSS Cough Score at Day 7
Time frame: Baseline and Day 7
Change From Baseline in BSS Sputum Score at Day 7
Time frame: Baseline and Day 7
Change From Baseline in BSS Rales/Rhonchi Score at Day 7
Time frame: Baseline and Day 7
Change From Baseline in BSS Chest Pain During Coughing Score at Day 7
Time frame: Baseline and Day 7
Change From Baseline in BSS Dyspnea Score at Day 7
Time frame: Baseline and Day 7
Percentage of Participants With BSS Total Score Below 3 at Day 7
Time frame: Baseline and Day 7
Percentage of Participants With a BSS Total Score Reduction of at Least 7 Points
Time frame: Baseline and Day 7
Percentage of Participants Meeting Both BSS Response Criteria
Time frame: Baseline and Day 7
Change From Baseline in Cough Assessment Test (COAT) Total Score at Day 7
Time frame: Baseline and Day 7
Investigator-rated Global Improvement at Day 7
Time frame: Day 7
Percentage of Participants With Investigator-rated Global Improvement at Day 7
Time frame: Day 7
Percentage of Participants With Participant-rated Global Improvement at Day 7
Time frame: Day 7
Participant Satisfaction With Treatment at Day 7
Time frame: Day 7
Number of Participants With Treatment-emergent Adverse Events
Time frame: From first dose through the Day 7 end-of-treatment assessment
Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Tests
Time frame: Screening/before treatment and Day 7
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Time frame: Screening/before treatment and Day 7
Number of Participants With Clinically Significant Abnormalities in Physical Examination
Time frame: Screening/before treatment and Day 7
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram
Time frame: Screening/before treatment 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 23 Sep 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data will not be shared to protect participant confidentiality. Study findings will be disseminated through scientific publications reporting aggregate results.
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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.
Kwang Ha Yoo study chair
Konkuk University Medical Center
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DSP2505(Canium) and Umckamin in people with Acute Bronchitis, run by Dasan Pharmaceutical Co., Ltd. at 12 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 5 inclusion and 12 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 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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) Total Score at Day 7 (time frame: Baseline and 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 23 Sep 2026.