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Clinical Study to Evaluate the Efficacy, Dose-response and Safety of SA09012 in Bronchial Asthma Patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SA09012 Low dose | Experimental |
| |
| SA09012 High dose | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SA09012 Low dose | Drug | Tablet, b.i.d |
| |
| SA09012 High dose |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline of PEF(Peak Expiratory Flow)at week 6 | 6 week treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in FEV1 at week 6 | 6 week treatment period | |
| Mean change from baseline in ACT(Asthma Control Test) at week 6 | 6 week treatment period | |
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Inclusion Criteria:
Diagnosis or presence of asthma within 3 months of the prestudy visit
FEV1 or PEF between 60% and 85% of the predicted value at screening or within the 3 months of the prestudy visit
Having signed an informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Young Kyoon Kim, MD | Seoul ST. Mary's Hospital The Catholic University of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonbuk National University Hospital | Chonbuk | South Korea | ||||
| Chonnam National University Hospital |
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| Drug |
Tablet, b.i.d |
|
| Placebo | Drug | Tablet, b.i.d |
|
| Safety assessment(Comparison of the adverse event profiles throughout the course of the study) |
| 6 week treatment period |
| Gwangju |
| South Korea |
| Ajou University Hospital | Gyeonggi-do | South Korea |
| Bucheon St. Mary's Hospital, The Catholic University of Korea | Gyeonggi-do | South Korea |
| Hallym University Sacred Heart Hospital | Gyeonggi-do | South Korea |
| Soon Chun Hyang University Bucheon Hospital | Gyeonggi-do | South Korea |
| Konkuk University Medical Center | Seoul | South Korea |
| Korea University Guro Hospital | Seoul | South Korea |
| KyungHee University Medical Center | Seoul | South Korea |
| Seoul St. Mary's Hospital, The Catholic University of Korea | Seoul | South Korea |
| Soonchunhyang University Hospital, Seoul | Seoul | South Korea |
| St. Paul's Hospital, The Catholic University of Korea | Seoul | South Korea |
| Yonsei University, Gangnam Severance Hospital | Seoul | South Korea |
| Chungbuk National University Hospital | Taebuk | South Korea |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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