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Clinical Study to Evaluate the Efficacy and Safety of Atock Dry Syrup with Acute bronchial Patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atock Dry Syrup | Experimental |
| |
| tulobuterol patch | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atock Dry Syrup with placebo patch | Drug | Atock Dry syrup (TID) with placebo patch (QD) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyeon Jong Yang, MD | Contact | +82-2-709-9390 | ilove902@hanmail.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soonchunhyang University Seoul Hospital | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D001991 | Bronchitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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| Tulobuterol patch with placebo dry syrup |
| Drug |
Tulobuterol patch (QD) with placebo dry syrup (TID) |
|
| 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 |
| 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 |
| 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 |
| D008173 |
| Lung Diseases, Obstructive |
| D008171 | Lung Diseases |