The Efficacy and Safety of Atock Dry Syrup With Acute Bronchitis Patients

Launched by SAMA PHARMACEUTICAL CO., LTD · May 10, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Atock Dry Syrup to see how effective and safe it is for treating patients with acute bronchitis, which is a condition that causes coughing and breathing difficulties. The trial is currently looking for participants, including children aged 6 months to under 12 years, who are experiencing symptoms of acute bronchitis, such as wheezing and coughing, within the last two days. To join the study, children must have a certain level of bronchitis severity, indicated by a specific scoring system.

Participants in this trial will receive the Atock Dry Syrup and will be monitored for how well it works and if there are any side effects. However, not everyone can participate. Those with chronic lung diseases, severe breathing problems, or certain health conditions like liver or kidney issues are not eligible. The trial aims to gather important information that could help improve treatment for acute bronchitis in children. It's a valuable opportunity for families looking for effective solutions for their child's respiratory health.

Gender

ALL

Eligibility 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
• 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 HbsAg or HCV Ab or HIV Ab tests at screening visit