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The objective of this study is to assess the efficacy and safety of SOTB07 in asthma patients by observing changes FEV1 (% predicted) as the primary efficacy endpoint after oral administration of SOTB07 200mg, 400mg, placebo for 12 weeks.
A 12-week, Multi-center, Randomized, Double blinded, Parallel group, Placebo-controlled study to Assess the Efficacy and Safety of SOTB07 in asthma patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOTB07 200mg | Experimental | One tablet of SOTB07 200mg and One tablet of SOTB 400mg Placebo are administered twice a day. |
|
| SOTB07 400mg | Experimental | One tablet of SOTB07 400mg and One tablet of SOTB 200mg Placebo are administered twice a day. |
|
| Placebo | Placebo Comparator | One tablet of SOTB 200mg Placebo and One tablet of SOTB 400mg Placebo are administered twice a day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOTB07 200mg | Drug |
| ||
| SOTB07 400mg |
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 change from the baseline | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in spirometer parameters | 12 weeks | |
| Change in FeNO | 12 weeks | |
| Change in AM/PM PEFR |
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Inclusion Criteria:
Male or eligible female subjects aged 15 years or more
A female is eligible if she is of:
Non-smoker for at least 1 year, a pack history of ≤ 10 pack years
Symptom of persistent asthma, as defined by the National Institute of Health (NIH) 5.50% ≤ FEV1 ≤ 80% predicted at screening visit (withholding inhaled, short acting ß-agonist for 6 hours)
6.FEV1 reversibility ≥ 12% and 200 ml at 20-30 minutes after inhalation of a short acting ß-agonist (Salbutamol 2 puffs; 200㎍) at Visit 1 or within 6 months before Visit 1 7.Capable of withholding salbutamol use for ≥ 6 hours prior to clinic visits 8.Appropriately signed and dated informed consent has been obtained
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sangheon Cho, professor | Seoul National University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | Seoul | 110-744 | South Korea |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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|
| SOTB 200mg placebo | Drug | Placebo of SOTB07 200mg |
|
| SOTB 400mg placebo | Drug | Placebo of SOTB07 400mg |
|
| 12 weeks |
| Change in diurnal asthma symptom score | 12 weeks |
| Change in the number of days with experience of nocturnal asthma symptoms | 12 weeks |
| Change in amount of beta-2 agonist used (puff/day) | 12 weeks |
| Proportion of rescue free day | 12 weeks |
| Proportion of asthma control day | 12 weeks |
| Proportion of asthma exacerbation | 12 weeks |
| Proportion of treatment failure (severe asthma exacerbation) | 12 weeks |
| Changes in asthma control questionaire score | 12 weeks |
| Changes in quality of life questionaire for adult korea asthmatics scores | 12 weeks |
| Changes in patient's global self assessment score | 12 weeks |
| Change in visual analogue scale for cough score | 12 weeks |
| Change in biomarkers (eosinophil, neutrophil, ECP, eotaxin) in blood sample | 12 weeks |
| Change in biomarkers (eosinophil, neutrophil, ECP, eotaxin) in sputum sample | 12 weeks |
| Assessment of Safety | Adverse Event/ Vital Sign/ Laboratory Test | 12 weeks |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |