RecruitingPhase 4NCT06411925
The Efficacy and Safety of Atock Dry Syrup With Acute Bronchitis Patients
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
Sponsor
SamA Pharmaceutical Co., Ltd
Enrollment
296 participants
Start Date
Nov 10, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
Clinical Study to Evaluate the Efficacy and Safety of Atock Dry Syrup with Acute bronchial Patients
Eligibility
Min Age: 6 MonthsMax Age: 11 Years
Inclusion Criteria5
- 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
Exclusion Criteria5
- Subjects with chronic respiratory diseases (e.g., asthma, COPD) or severe respiratory diseases (e.g., pneumonia, cystic fibrosis, influenza, active tuberculosis)
- Subjects under treatment with corticosteroids, antibiotics medications
- Subjects with severe hepatic and renal impairment
- Subjects with a history of drug abuse
- Subject with positive results in HIV Ab test
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Interventions
DRUGAtock Dry Syrup with placebo patch
Atock Dry syrup (TID) with placebo patch (QD)
DRUGTulobuterol patch with placebo dry syrup
Tulobuterol patch (QD) with placebo dry syrup (TID)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06411925