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

SamA Pharmaceutical Co., Ltd1 site in 1 country296 target enrollmentNovember 10, 2023

ConditionsAcute Bronchitis

InterventionsAtock Dry Syrup with placebo patch Tulobuterol patch with placebo dry syrup

Overview

Phase: Phase 4
Intervention: Atock Dry Syrup with placebo patch
Conditions: Acute Bronchitis
Sponsor: SamA Pharmaceutical Co., Ltd
Enrollment: 296
Locations: 1
Primary Endpoint: The rate of subjects whose symptoms improved based on the wheezing score at 3 days
Status: Recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

November 10, 2023

End Date

September 1, 2027

Last Updated

7 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

SamA Pharmaceutical Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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

Arms & Interventions

Atock Dry Syrup

Intervention: Atock Dry Syrup with placebo patch

tulobuterol patch

Intervention: Tulobuterol patch with placebo dry syrup

Outcomes

Primary Outcomes

The rate of subjects whose symptoms improved based on the wheezing score at 3 days

Time Frame: 3 days treatment period

The rating was: 0=No wheezing (None); 1=mild (End expiration with stethoscope); 2=moderate (Inspiration and expiration with stethoscope) and 3=severe (Audible without stethoscope).

Secondary Outcomes

The change in patient satisfaction scores for wheezing (VAS, Visual Analogue Scale) at 3 and 7 days(3 and 7 days treatment period)
The change in bronchitis severity score excluding the sputum (BSSEs) at 3 and 7 days(3 and 7 days treatment period)
The rate of subjects whose wheezing score improved by two or more grades at 3 and 7 days(3 and 7 days treatment period)
The rate of subjects whose symptoms improved based on the wheezing score at 7 days(7 days treatment period)
The change in patient satisfaction scores for cough (COAT, COugh Assessment Test) at 3 and 7 days(3 and 7 days treatment period)