Evaluating Atock Dry Syrup for Children with Acute Bronchitis
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
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 |
| Enrollment | 296 (estimated) |
| Ages | 6 Months to 11 Years |
| Sex | All |
| Sponsor | SamA Pharmaceutical Co., Ltd Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06411925 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 months to under 12 years with moderate to severe symptoms of acute bronchitis.
Not a fit: Patients with chronic respiratory diseases or those currently on corticosteroids or antibiotics may not benefit from this study.
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 performed: While there may be existing studies on treatments for acute bronchitis, the specific use of Atock Dry Syrup in this context is novel.
Eligibility criteria
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 this trial is running
Seoul
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.