Clinical trial NCT01907763: Study Phase III Study to Assess the Efficacy and Safety of SOTB07 in Asthma Patients
Official title: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Asthma
Keywords: asthma
SOTB07
Lead sponsor: SK Chemicals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-07-25
Enrollment: 194
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: FEV1 change from the baseline
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in spirometer parameters
timeFrame: 12 weeks
measure: Change in FeNO
timeFrame: 12 weeks
measure: Change in AM/PM PEFR
timeFrame: 12 weeks
measure: Change in diurnal asthma symptom score
timeFrame: 12 weeks
measure: Change in the number of days with experience of nocturnal asthma symptoms
timeFrame: 12 weeks
measure: Change in amount of beta-2 agonist used (puff/day)
timeFrame: 12 weeks
measure: Proportion of rescue free day
timeFrame: 12 weeks
measure: Proportion of asthma control day
timeFrame: 12 weeks
measure: Proportion of asthma exacerbation
timeFrame: 12 weeks
measure: Proportion of treatment failure (severe asthma exacerbation)
timeFrame: 12 weeks
measure: Changes in asthma control questionaire score
timeFrame: 12 weeks
measure: Changes in quality of life questionaire for adult korea asthmatics scores
timeFrame: 12 weeks
measure: Changes in patient's global self assessment score
timeFrame: 12 weeks
measure: Change in visual analogue scale for cough score
timeFrame: 12 weeks
measure: Change in biomarkers (eosinophil, neutrophil, ECP, eotaxin) in blood sample
timeFrame: 12 weeks
measure: Change in biomarkers (eosinophil, neutrophil, ECP, eotaxin) in sputum sample
timeFrame: 12 weeks
measure: Assessment of Safety
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Sangheon Cho, professor
role: STUDY_CHAIR
References: