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

Acute Bronchitis Clinical Trial

Official title:

A Multi-center, Randomized, Double-blinded, Active-controlled, Superiority, Phase 4 Trial to Evaluate the Efficacy and Safety of Atock Dry Syrup Sama With Acute Bronchitis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06411925
• Other study ID #: SA21901-2
• Status: Recruiting
• Phase: Phase 4
• Start date: November 10, 2023
• Est. completion date: August 2025

Study information

• Verified date: May 2024
• Source: SamA Pharmaceutical Co., Ltd
• Contact: Hyeon Jong Yang, MD
• Phone: +82-2-709-9390
• Email: ilove902[@]hanmail.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: August 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Bronchitis
• Acute Disease
• Bronchitis

Intervention

Drug:
• Atock Dry Syrup
Dry syrup, TID
• Placebo
Dry syrup, TID

Locations

Country	Name	City	State
Korea, Republic of	Soonchunhyang University Seoul Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
SamA Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The rate of subjects whose symptoms improved based on the wheezing score at 7 days		7 days treatment period
Secondary	The rate of subjects whose wheezing score improved by two or more grades at 3 and 7 days		3 and 7 days treatment period
Secondary	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	3 and 7 days treatment period
Secondary	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.	3 and 7 days treatment period
Secondary	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.	3 and 7 days treatment period