Acute BronchitisPhase 4NCT06411925
The Efficacy and Safety of Atock Dry Syrup With Acute Bronchitis Patients
A Phase 4 study of Acute Bronchitis, run by SamA Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
Clinical Study to Evaluate the Efficacy and Safety of Atock Dry Syrup with Acute bronchial Patients Read more about this study
- Who is it for?
- Ages 6 months to 11 years
- Conditions the study is for
- Acute Bronchitis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 296 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Nov 2023to Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 6 months to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged ≥6 months to <12 years old
- Total Bronchitis Severity Scale excluding sputum(BSSEs) ≥4
- Wheezing score ≥2
- Subjects who present symptoms of Acute Bronchitis within 48 hours from screening visit
- Subject with negative results in HbsAg or HCV Ab test within 6 months from screening visit
Who cannot join
- Subjects with chronic respiratory diseases (e.g., asthma, COPD) or severe respiratory diseases (e.g., pneumonia, cystic fibrosis, influenza, active tuberculosis)
- Subjects under treatment with corticosteroids, antibiotics medications
- Subjects with severe hepatic and renal impairment
- Subjects with a history of drug abuse
- Subject with positive results in HIV Ab test
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Soonchunhyang University Seoul Hospital
Seoul
Hyeon Jong Yang, MD
About this study
Official title: A Multi-center, Randomized, Double-blinded, Active-controlled, Non-inferiority, Phase 4 Trial to Evaluate the Efficacy and Safety of Atock Dry Syrup Sama With Acute Bronchitis Patients
Clinical Study to Evaluate the Efficacy and Safety of Atock Dry Syrup with Acute bronchial Patients
- Conditions
- Acute Bronchitis
- Being tested
- Atock Dry Syrup with placebo patch, Tulobuterol patch with placebo dry syrup
- Medical subject headings
- Bronchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atock Dry Syrup with placebo patchDrug
Atock Dry syrup (TID) with placebo patch (QD)
Tulobuterol patch with placebo dry syrupDrug
Tulobuterol patch (QD) with placebo dry syrup (TID)
| Study group | Role | What they receive |
|---|---|---|
| Atock Dry Syrup | Experimental | Not described Receives: Drug: Atock Dry Syrup with placebo patch |
| tulobuterol patch | Active comparator | Not described Receives: Drug: Tulobuterol patch with placebo dry syrup |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of subjects whose symptoms improved based on the wheezing score at 3 days
The rating was: 0=No wheezing (None); 1=mild (End expiration with stethoscope); 2=moderate (Inspiration and expiration with stethoscope) and 3=severe (Audible without stethoscope).
Measured: 3 days treatment period
Secondary outcomes (5)
The rate of subjects whose symptoms improved based on the wheezing score at 7 days
Measured: 7 days treatment period
The rate of subjects whose wheezing score improved by two or more grades at 3 and 7 days
Measured: 3 and 7 days treatment period
The change in bronchitis severity score excluding the sputum (BSSEs) at 3 and 7 days
- The BSSEs comprises the following four symptoms typical for Acute Bronchitis: cough, chest pain on coughing, crackle and dyspnea. These symptoms are each assessed according to a 5-point Likert scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe
Measured: 3 and 7 days treatment period
The change in patient satisfaction scores for wheezing (VAS, Visual Analogue Scale) at 3 and 7 days
VAS consists of a horizontal line, usually 100 in length and select a point on the scale indicating the level of satisfaction for wheezing in the 3 and 7 days. The number 0 indicates not satisfaction and 100 indicates very satisfaction.
Measured: 3 and 7 days treatment period
The change in patient satisfaction scores for cough (COAT, COugh Assessment Test) at 3 and 7 days
All items can be scored as a single scale (0-4 scaling of each item, 0-20 total score range). Higher scores represent more severe cough.
Measured: 3 and 7 days treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start10 Nov 2023
- Primary completionJul 2027 (estimated)
- Study completionSep 2027 (estimated)
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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 296 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SamA Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06411925
- Sponsor's protocol ID
- SA21901-2
- Status last verified
- Sep 2025
- First submitted
- 2 May 2024
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blinded, Active-controlled, Non-inferiority, Phase 4 Trial to Evaluate the Efficacy and Safety of Atock Dry Syrup Sama With Acute Bronchitis Patients
- ClinicalTrials.gov ID
- NCT06411925
- Acronym / sponsor ID
- SA21901-2
- Conditions
- Acute Bronchitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 296 participants (estimated)
- Lead sponsor
- SamA Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 13 May 2024 (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.
Clinical Study to Evaluate the Efficacy and Safety of Atock Dry Syrup with Acute bronchial Patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atock Dry Syrup | Experimental | Drug: Atock Dry Syrup with placebo patch |
| tulobuterol patch | Active comparator | Drug: Tulobuterol patch with placebo dry syrup |
Who may qualify
- Ages
- 6 months to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged ≥6 months to <12 years old
- Total Bronchitis Severity Scale excluding sputum(BSSEs) ≥4
- Wheezing score ≥2
- Subjects who present symptoms of Acute Bronchitis within 48 hours from screening visit
- Subject with negative results in HbsAg or HCV Ab test within 6 months from screening visit
Key exclusion criteria (5 listed)
- Subjects with chronic respiratory diseases (e.g., asthma, COPD) or severe respiratory diseases (e.g., pneumonia, cystic fibrosis, influenza, active tuberculosis)
- Subjects under treatment with corticosteroids, antibiotics medications
- Subjects with severe hepatic and renal impairment
- Subjects with a history of drug abuse
- Subject with positive results in HIV Ab test
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 |
|---|---|---|
| Atock Dry Syrup with placebo patchAtock Dry syrup (TID) with placebo patch (QD) | Drug | Atock Dry Syrup |
| Tulobuterol patch with placebo dry syrupTulobuterol patch (QD) with placebo dry syrup (TID) | Drug | tulobuterol patch |
Primary outcome
The rate of subjects whose symptoms improved based on the wheezing score at 3 days
Time frame: 3 days treatment period
The rating was: 0=No wheezing (None); 1=mild (End expiration with stethoscope); 2=moderate (Inspiration and expiration with stethoscope) and 3=severe (Audible without stethoscope).
5 secondary outcomes
The rate of subjects whose symptoms improved based on the wheezing score at 7 days
Time frame: 7 days treatment period
The rate of subjects whose wheezing score improved by two or more grades at 3 and 7 days
Time frame: 3 and 7 days treatment period
The change in bronchitis severity score excluding the sputum (BSSEs) at 3 and 7 days
Time frame: 3 and 7 days treatment period
The change in patient satisfaction scores for wheezing (VAS, Visual Analogue Scale) at 3 and 7 days
Time frame: 3 and 7 days treatment period
The change in patient satisfaction scores for cough (COAT, COugh Assessment Test) at 3 and 7 days
Time frame: 3 and 7 days treatment period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
Related trials for Acute Bronchitis
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Active, not recruiting
Respiratory Support and Treatment for Efficient and Cost-Effective Care
Bronchiolitis
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Study Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD) With Chronic Bronchitis
Chronic Obstructive Pulmonary Disease With Chronic Bronchitis
Not yet recruiting
Influence of Patient Positioning During Nasal Lavage
Acute Upper Respiratory Tract Infections, Nasal Obstruction
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Acute Bronchitis, run by SamA Pharmaceutical 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 23 Sep 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hyeon Jong Yang, MD (+82-2-709-9390, ilove902@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of subjects whose symptoms improved based on the wheezing score at 3 days (time frame: 3 days treatment period). 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 2025.