Acute Bronchitis
Conditions
Brief summary
Clinical Study to Evaluate the Efficacy and Safety of Atock Dry Syrup with Acute bronchial Patients
Interventions
DRUGTulobuterol patch with placebo dry syrup
Tulobuterol patch (QD) with placebo dry syrup (TID)
DRUGAtock Dry Syrup with placebo patch
Atock Dry syrup (TID) with placebo patch (QD)
Sponsors
SamA Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to 11 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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. |
Countries
South Korea
Contacts
Primary ContactHyeon Jong Yang, MD
Outcome results
None listed