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

Phase 4

Recruiting

• Conditions: Acute Bronchitis
• Interventions: Drug: Atock Dry Syrup; Drug: Placebo

• Registration Number: NCT06411925
• Lead Sponsor: SamA Pharmaceutical Co., Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-10
• Status Verified: 2024-05
• Study First Submitted: 2024-05-02
• Study First Submitted QC: 2024-05-10
• Last Update Submitted: 2024-05-10
• Study First Posted: 2024-05-13
• Last Update Posted: 2024-05-13
• Primary Completion: 2025-07
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 260

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

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 HbsAg or HCV Ab or HIV Ab tests at screening visit

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atock Dry Syrup	Atock Dry Syrup	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
The rate of subjects whose symptoms improved based on the wheezing score at 3 days	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 Outcome Measures

Name	Time	Method
The change in patient satisfaction scores for wheezing (VAS, Visual Analogue Scale) at 3 and 7 days	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.
The change in bronchitis severity score excluding the sputum (BSSEs) at 3 and 7 days	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
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 rate of subjects whose symptoms improved based on the wheezing score at 7 days	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	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.

Trial Locations

Locations (1)

Soonchunhyang University Seoul Hospital; 🇰🇷 Seoul, Korea, Republic of