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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
194
Seoul National University Hospital
Seoul, Seoul, South Korea
FEV1 change from the baseline
Time frame: 12 weeks
Change in spirometer parameters
Time frame: 12 weeks
Change in FeNO
Time frame: 12 weeks
Change in AM/PM PEFR
Time frame: 12 weeks
Change in diurnal asthma symptom score
Time frame: 12 weeks
Change in the number of days with experience of nocturnal asthma symptoms
Time frame: 12 weeks
Change in amount of beta-2 agonist used (puff/day)
Time frame: 12 weeks
Proportion of rescue free day
Time frame: 12 weeks
Proportion of asthma control day
Time frame: 12 weeks
Proportion of asthma exacerbation
Time frame: 12 weeks
Proportion of treatment failure (severe asthma exacerbation)
Time frame: 12 weeks
Changes in asthma control questionaire score
Time frame: 12 weeks
Changes in quality of life questionaire for adult korea asthmatics scores
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Placebo of SOTB07 400mg
Time frame: 12 weeks
Changes in patient's global self assessment score
Time frame: 12 weeks
Change in visual analogue scale for cough score
Time frame: 12 weeks
Change in biomarkers (eosinophil, neutrophil, ECP, eotaxin) in blood sample
Time frame: 12 weeks
Change in biomarkers (eosinophil, neutrophil, ECP, eotaxin) in sputum sample
Time frame: 12 weeks
Assessment of Safety
Adverse Event/ Vital Sign/ Laboratory Test
Time frame: 12 weeks