Evaluating Atock Dry Syrup for Children with Acute Bronchitis
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
Run by SamA Pharmaceutical Co., Ltd · NCT06411925 · Data updated 2026-11-12
This study tests if Atock Dry Syrup can help children aged 6 months to under 12 years with acute bronchitis feel better compared to a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 6 Months to 11 Years |
| Sex | All |
| Enrollment | 296 (estimated) |
| Sponsor | SamA Pharmaceutical Co., Ltd Industry-sponsored |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | November 10, 2023 |
| Main results expected | July 2027 |
| Study ends | September 2027 |
| Registry record updated | September 23, 2025 |
| Trial ID | NCT06411925 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 6 months to under 12 years with moderate to severe symptoms of acute bronchitis.
✕Probably not a fit
Patients with chronic respiratory diseases or those currently on corticosteroids or antibiotics may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial assesses the efficacy and safety of Atock Dry Syrup in treating children aged 6 months to under 12 years who are experiencing acute bronchitis. Participants will be evaluated based on their bronchitis severity and wheezing scores, with some receiving the Atock Dry Syrup and others receiving a placebo. The study aims to determine whether the syrup can effectively alleviate symptoms of acute bronchitis in this pediatric population.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for managing acute bronchitis in children.
How similar studies have gone: While there may be existing studies on treatments for acute bronchitis, the specific use of Atock Dry Syrup in this context is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Children aged ≥6 months to \<12 years old 2. Total Bronchitis Severity Scale excluding sputum(BSSEs) ≥4 3. Wheezing score ≥2 4. Subjects who present symptoms of Acute Bronchitis within 48 hours from screening visit 5. Subject with negative results in HbsAg or HCV Ab test within 6 months from screening visit Exclusion Criteria: 1. Subjects with chronic respiratory diseases (e.g., asthma, COPD) or severe respiratory diseases (e.g., pneumonia, cystic fibrosis, influenza, active tuberculosis) 2. Subjects under treatment with corticosteroids, antibiotics medications 3. Subjects with severe hepatic and renal impairment 4. Subjects with a history of drug abuse 5. Subject with positive results in HIV Ab test
Where it's running
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Soonchunhyang University Seoul Hospital
Seoul, South Korea Recruiting
Study contacts
- Study coordinator: Hyeon Jong Yang, MD
- Email: ilove902@hanmail.net
- Phone: +82-2-709-9390
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Raphamin for acute bronchitis in adults
This study tests whether Raphamin helps adults with acute bronchitis feel better faster compared with a placebo.
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Shortening antibiotic courses for common throat and chest infections in primary care with doctor–pharmacist teamwork and viral‑circulation updates
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.