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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
Clinical Study to Evaluate the Efficacy and Safety of Atock Dry Syrup with Acute bronchial Patients
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 11
Healthy Volunteers: f
View:
• Children aged ≥6 months to \<12 years old
• Total Bronchitis Severity Scale excluding sputum(BSSEs) ≥4
• Wheezing score ≥2
• Subjects who present symptoms of Acute Bronchitis within 48 hours from screening visit
• Subject with negative results in HbsAg or HCV Ab test within 6 months from screening visit
Locations
Other Locations
Republic of Korea
Soonchunhyang University Seoul Hospital
RECRUITING
Seoul
Contact Information
Primary
Hyeon Jong Yang, MD
ilove902@hanmail.net
+82-2-709-9390
Time Frame
Start Date: 2023-11-10
Estimated Completion Date: 2027-09
Participants
Target number of participants: 296
Treatments
Experimental: Atock Dry Syrup
Active_comparator: tulobuterol patch
Related Therapeutic Areas
Sponsors
Leads: SamA Pharmaceutical Co., Ltd