The Efficacy and Safety of Atock Dry Syrup With Acute Bronchitis Patients
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
1 other identifier
interventional
296
1 country
1
Brief Summary
Clinical Study to Evaluate the Efficacy and Safety of Atock Dry Syrup with Acute bronchial Patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2023
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 10, 2023
CompletedFirst Submitted
Initial submission to the registry
May 2, 2024
CompletedFirst Posted
Study publicly available on registry
May 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
September 23, 2025
September 1, 2025
3.6 years
May 2, 2024
September 18, 2025
Conditions
Outcome Measures
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).
3 days treatment period
Secondary Outcomes (5)
The rate of subjects whose symptoms improved based on the wheezing score at 7 days
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 change in bronchitis severity score excluding the sputum (BSSEs) at 3 and 7 days
3 and 7 days treatment period
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 patient satisfaction scores for cough (COAT, COugh Assessment Test) at 3 and 7 days
3 and 7 days treatment period
Study Arms (2)
Atock Dry Syrup
EXPERIMENTALtulobuterol patch
ACTIVE COMPARATORInterventions
Tulobuterol patch (QD) with placebo dry syrup (TID)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Soonchunhyang University Seoul Hospital
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2024
First Posted
May 13, 2024
Study Start
November 10, 2023
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
September 23, 2025
Record last verified: 2025-09