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

SamA Pharmaceutical

Status and phase: Enrolling; Phase 4

Conditions: Acute Bronchitis

Treatments: Drug: Tulobuterol patch with placebo dry syrup; Drug: Atock Dry Syrup with placebo patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT06411925

SA21901-2

Details and patient eligibility

About

Clinical Study to Evaluate the Efficacy and Safety of Atock Dry Syrup with Acute bronchial Patients

Enrollment: 296 estimated patients

Sex: All

Ages: 6 months to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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296 participants in 2 patient groups

Atock Dry Syrup

Experimental group

Treatment:

Drug: Atock Dry Syrup with placebo patch

tulobuterol patch

Active Comparator group

Treatment:

Drug: Tulobuterol patch with placebo dry syrup