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NCT Number: NCT06411925

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

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

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Key information

Conditions

Acute Bronchitis Bronchial Diseases Bronchitis Infections Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

6 month–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Soonchunhyang University Seoul Hospital

Seoul, South Korea

Location status: Recruiting

Location contact

Hyeon Jong Yang, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atock Dry Syrup with placebo patch

Drug

Atock Dry syrup (TID) with placebo patch (QD)

Tulobuterol patch with placebo dry syrup

Drug

Tulobuterol patch (QD) with placebo dry syrup (TID)

Primary outcomes

  1. 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

  1. The rate of subjects whose symptoms improved based on the wheezing score at 7 days

    Time frame: 7 days treatment period

  2. 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. 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

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hyeon Jong Yang, MD

CONTACT

[email protected]

+82-2-709-9390

Sponsors and collaborators

Lead sponsor

SamA Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 13, 2024
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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