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

September 18, 2025 updated by: SamA Pharmaceutical Co., Ltd

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

296

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
      • Seoul, South Korea
        • Recruiting
        • Soonchunhyang University Seoul Hospital
        • Contact:
          • Hyeon Jong Yang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Atock Dry Syrup
Drug: Atock Dry Syrup with placebo patch
Atock Dry syrup (TID) with placebo patch (QD)
Active Comparator: tulobuterol patch
Drug: Tulobuterol patch with placebo dry syrup
Tulobuterol patch (QD) with placebo dry syrup (TID)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
3 days treatment period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of subjects whose symptoms improved based on the wheezing score at 7 days
Time Frame: 7 days treatment period
7 days treatment period
The rate of subjects whose wheezing score improved by two or more grades at 3 and 7 days
Time Frame: 3 and 7 days treatment period
3 and 7 days treatment period
The change in bronchitis severity score excluding the sputum (BSSEs) at 3 and 7 days
Time Frame: 3 and 7 days treatment period
• The BSSEs comprises the following four symptoms typical for Acute Bronchitis: cough, chest pain on coughing, crackle and dyspnea. These symptoms are each assessed according to a 5-point Likert scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe
3 and 7 days treatment period
The change in patient satisfaction scores for wheezing (VAS, Visual Analogue Scale) at 3 and 7 days
Time Frame: 3 and 7 days treatment period
VAS consists of a horizontal line, usually 100 in length and select a point on the scale indicating the level of satisfaction for wheezing in the 3 and 7 days. The number 0 indicates not satisfaction and 100 indicates very satisfaction.
3 and 7 days treatment period
The change in patient satisfaction scores for cough (COAT, COugh Assessment Test) at 3 and 7 days
Time Frame: 3 and 7 days treatment period
All items can be scored as a single scale (0-4 scaling of each item, 0-20 total score range). Higher scores represent more severe cough.
3 and 7 days treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SamA Pharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2023

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

May 2, 2024

First Submitted That Met QC Criteria

May 10, 2024

First Posted (Actual)

May 13, 2024

Study Record Updates

Last Update Posted (Estimated)

September 23, 2025

Last Update Submitted That Met QC Criteria

September 18, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SA21901-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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