Status:
COMPLETED
Dose Finding Trial to Assess the Efficacy and Safety of SOTB07 in Persistent Asthma
Lead Sponsor:
SK Chemicals Co., Ltd.
Conditions:
Asthma
Eligibility:
All Genders
15+ years
Phase:
PHASE2
Brief Summary
This study is a dose finding trial to assess the efficacy and safety of SOTB07 in persistent asthma.
Detailed Description
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.
Eligibility Criteria
Inclusion
- Male or eligible female subjects aged 15 years or more
- 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
- 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
- Active upper or lower respiratory tract infection within 3 weeks before visit 1
- Emergency room treatment for asthma within 1 month or hospitalization for asthma within 3 months before visit 1
- Any evidence of infectious, oncologic, or other active pulmonary disease obtained by chest radiography within 12 months before visit 1
- Clinically significant, in the opinion of the investigator, hematological, liver, renal, heart, neurological disease, or other serious disease
- Hypersensitivity to any β2-agonist, sympathomimetic drug, leukotriene receptor antagonist or Sophora tonkinensis Radix Rhizoma
- Clinically significant and uncontrolled psychiatric disease or history of drug or alcohol abuse
- Inhaled, oral or parenteral corticosteroids within 4 weeks before visit 1
- Change of Immunotherapy within 6 months before visit 1
- Administration of the antiasthma agent within 1 week of visit 1
- Administration of any other medication which may affect the course of asthma, or interact with sympathomimetic amines
- Participation in study using an experimental medication within 1 month before visit 1
- Other ineligible subject in the opinion of the investigator
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
245 Patients enrolled
Trial Details
Trial ID
NCT00936624
Start Date
July 1 2009
End Date
May 1 2011
Last Update
December 19 2013
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 110-744