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

NCT ID: NCT06411925

Last Updated: 2025-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

296 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-10

Study Completion Date

2027-09-30

Brief Summary

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

Detailed Description

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Conditions

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Acute Bronchitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Atock Dry Syrup

Group Type EXPERIMENTAL

Atock Dry Syrup with placebo patch

Intervention Type DRUG

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

tulobuterol patch

Group Type ACTIVE_COMPARATOR

Tulobuterol patch with placebo dry syrup

Intervention Type DRUG

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

Interventions

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Atock Dry Syrup with placebo patch

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

Intervention Type DRUG

Tulobuterol patch with placebo dry syrup

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SamA Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Soonchunhyang University Seoul Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hyeon Jong Yang, MD

Role: CONTACT

+82-2-709-9390

Facility Contacts

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Hyeon Jong Yang, MD

Role: primary

Other Identifiers

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SA21901-2

Identifier Type: -

Identifier Source: org_study_id

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