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This study is a dose finding trial to assess the efficacy and safety of SOTB07 in persistent asthma.
A 12 week, Multi-center, Randomized, Double blinded, Parallel group, Placebo-controlled, 4-arm, Dose finding trial to Assess the Efficacy and Safety of SOTB07 in persistent asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOTB07 100mg | Experimental |
| |
| SOTB07 200mg | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| Montelukast 10mg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOTB07 | Drug | SOTB07 100mg |
| |
| SOTB07 |
| Measure | Description | Time Frame |
|---|---|---|
| % change from baseline for FEV1 at each visit | 12 weeks |
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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)
50% ≤ FEV1 ≤ 85% predicted at screening visit (withholding inhaled, short acting ß-agonist for 6 hours)
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
Capable of withholding salbutamol use for ≥ 6 hours prior to clinic visits
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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | 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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| ID | Term |
|---|---|
| C093875 | montelukast |
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| Drug |
SOTB07 200mg |
|
| placebo | Drug | placebo |
|
| montelukast | Drug | montelukast 10mg po, bid, 12week |
|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |