Actively Recruiting
Phase 4 Study to Compare Atock Dry Syrup and Tulobuterol Patch for Treating Children With Acute Bronchitis
Led by SamA Pharmaceutical Co., Ltd · Updated on 2025-09-23
296
Participants Needed
1
Research Sites
8 weeks
Total Duration
AI-Summary
What this Trial Is About
This trial studies children aged 6 months to under 12 years with acute bronchitis to evaluate the efficacy and safety of Atock Dry Syrup compared to a tulobuterol patch. It is a randomized, double-blind, phase 4 trial aiming to assess if Atock Dry Syrup is not inferior to current treatment for improving bronchitis symptoms in this young population. Participants are randomly assigned to one of two groups one receives Atock Dry Syrup three times daily with a placebo patch once daily, and the other receives a tulobuterol patch once daily with placebo dry syrup three times daily. Treatment lasts 7 days, with primary assessment of wheezing score improvement after 3 days and additional evaluations at 7 days. Children enrolled will have their symptoms monitored using wheezing scores, bronchitis severity scales excluding sputum, and patient satisfaction scales for wheezing and cough. Safety is also evaluated, including tests for hepatitis B and C and HIV. The study measures symptom improvements at 3 and 7 days to determine treatment impact, with overall participation lasting up to one week of treatment and follow-up.
CONDITIONS
Brief Title
The Efficacy and Safety of Atock Dry Syrup With Acute Bronchitis Patients
Research Team
H
Hyeon Jong Yang, MD
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