Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 6 Months to 11

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

PhasePhase 4
Study typeInterventional
Ages6 Months to 11 Years
SexAll
Enrollment296 (estimated)
SponsorSamA Pharmaceutical Co., Ltd
Industry-sponsored
Locations1 site (Seoul)
StatusRecruiting
StartedNovember 10, 2023
Main results expectedJuly 2027
Study endsSeptember 2027
Registry record updatedSeptember 23, 2025
Trial IDNCT06411925 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

  • Soonchunhyang University Seoul Hospital
    Seoul, South Korea
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.