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RecruitingNCT06411925Updated Sep 23, 2025

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

A Phase 4 interventional study of Atock Dry Syrup with placebo patch and Tulobuterol patch with placebo dry syrup in Acute Bronchitis, sponsored by SamA Pharmaceutical Co., Ltd. Recruiting at 1 site in South Korea. Open to participants aged 6 Months to 11 Years. Per ClinicalTrials.gov, last updated 2025-09-23.

Sponsored by SamA Pharmaceutical Co., Ltd · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Nov 2023, registered May 2024).
  • Started Nov 2023; still recruiting 3 years later.
Phase
Phase 4
Study type
Interventional
Enrollment
296
Allocation
Randomized
Ages
6 Months to 11 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Acute Bronchitis

Browse trials for

03

In context

Bronchitis

156 studies on the registry are indexed under Bronchitis; 21 are open to participants now.

This study's planned enrollment of 296 is above the median of 185 across 105 interventional studies indexed under Bronchitis.

Browse Bronchitis studies →

Lead sponsor

SamA Pharmaceutical Co., Ltd is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 11 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 Ab test within 6 months from screening visit

Exclusion criteria

Exclusion Criteria:

  1. Subjects with chronic respiratory diseases (e.g., asthma, ) or severe respiratory diseases (e.g., pneumonia, cystic fibrosis, influenza, active tuberculosis)
  2. Subjects under treatment with , antibiotics medications
  3. Subjects with severe hepatic and renal impairment
  4. Subjects with a history of drug abuse
  5. Subject with positive results in Ab test
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
296 participants (estimated)

Study arms

  • Experimental
    Atock Dry Syrup

    Drug: Atock Dry Syrup with placebo patch

  • Active comparator
    tulobuterol patch

    Drug: Tulobuterol patch with placebo dry syrup

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)

06

What researchers measure

Primary outcomes

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

    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).

    Time frame: 3 days treatment period

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

    • 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

    Time frame: 3 and 7 days treatment period

  4. The change in patient satisfaction scores for wheezing (VAS, Visual Analogue Scale) at 3 and 7 days

    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.

    Time frame: 3 and 7 days treatment period

  5. The change in patient satisfaction scores for cough (COAT, COugh Assessment Test) at 3 and 7 days

    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.

    Time frame: 3 and 7 days treatment period

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2023 (actual). Primary completion is estimated for Jul 2027, 44 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 2, 2024
First posted
May 13, 2024
StartActual
Nov 10, 2023
Primary completionEst.
Jul 2027
CompletionEst.
Sep 2027
Last update
Sep 23, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06411925
Lead sponsor
SamA Pharmaceutical Co., Ltd
Responsible party
Sponsor
First posted
May 13, 2024
Start date
Nov 10, 2023
Primary completion
Jul 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Sep 23, 2025

Study contacts

Hyeon Jong Yang, MD
Contact
ilove902@hanmail.net
+82-2-709-9390

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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