Asthma
Conditions
Keywords
asthma, SOTB07
Brief summary
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.
Detailed description
A 12-week, Multi-center, Randomized, Double blinded, Parallel group, Placebo-controlled study to Assess the Efficacy and Safety of SOTB07 in asthma patients
Interventions
DRUGSOTB07 200mg
DRUGSOTB07 400mg
DRUGSOTB 200mg placebo
Placebo of SOTB07 200mg
DRUGSOTB 400mg placebo
Placebo of SOTB07 400mg
Sponsors
SK Chemicals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or eligible female subjects aged 15 years or more 2. A female is eligible if she is of: * Non-child bearing potential (i.e., physiologically incapable of becoming pregnant), including any female who is at least 2 year after post- menopausal * Child bearing potential and agrees to the acceptable contraceptive methods used consistently and correctly * Negative pregnancy test at screening 3. Non-smoker for at least 1 year, a pack history of ≤ 10 pack years 4. 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
1. Active upper or lower respiratory tract infection within 3 weeks before visit 1 2. Emergency room treatment for asthma within 1 month or hospitalization for asthma within 3 months before visit 1 3. Any evidence of infectious, oncologic, or other active pulmonary disease obtained by chest radiography within 12 months before visit 1 4. Clinically significant, in the opinion of the investigator, hematological, liver, renal, heart, neurological disease, or other serious disease 5. Hypersensitivity to any β2-agonist, sympathomimetic drug, leukotriene receptor antagonist or Sophora tonkinensis Radix Rhizoma 6. Clinically significant and uncontrolled psychiatric disease 7. history of drug or alcohol abuse 8. Inhaled, oral or parenteral corticosteroids within 4 weeks before visit 1 9. Change of Immunotherapy within 6 months before visit 1 10. Administration of the antiasthma agent within 1 week of visit 1 11. Administration of any other medication which may affect the course of asthma, or interact with sympathomimetic amines 12. Participation in study using an experimental medication within 1 month before visit 1 13. Other ineligible subject in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FEV1 change from the baseline | 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in FeNO | 12 weeks | — |
| Change in AM/PM PEFR | 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 | — |
| Change in spirometer parameters | 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 | 12 weeks | Adverse Event/ Vital Sign/ Laboratory Test |
| Proportion of treatment failure (severe asthma exacerbation) | 12 weeks | — |
Countries
South Korea
Outcome results
None listed