Dose Finding Trial to Assess the Efficacy and Safety of SOTB07 in Persistent Asthma | RxWiki

Dose Finding Trial to Assess the Efficacy and Safety of SOTB07 in Persistent Asthma

Overview[ - collapse ][ - ]

Purpose	This study is a dose finding trial to assess the efficacy and safety of SOTB07 in persistent asthma.
Condition	Asthma
Intervention	Drug: SOTB07 Drug: SOTB07 Drug: placebo Drug: montelukast
Phase	Phase 2
Sponsor	SK Chemicals Co.,Ltd.
Responsible Party	SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier	NCT00936624
First Received	July 8, 2009
Last Updated	December 17, 2013
Last verified	December 2013

Tracking Information[ + expand ][ + ]

First Received Date	July 8, 2009
Last Updated Date	December 17, 2013
Start Date	July 2009
Estimated Primary Completion Date	May 2011
Current Primary Outcome Measures	% change from baseline for FEV1 at each visit [Time Frame: 12 weeks] [Designated as safety issue: Yes]
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	Dose Finding Trial to Assess the Efficacy and Safety of SOTB07 in Persistent Asthma
Official Title	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
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.
Study Type	Interventional
Study Phase	Phase 2
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition	Asthma
Intervention	Drug: SOTB07 SOTB07 100mg Drug: SOTB07 SOTB07 200mg Drug: placebo placebo Drug: montelukast montelukast 10mg po, bid, 12week
Study Arm (s)	Experimental: SOTB07 100mg Experimental: SOTB07 200mg Placebo Comparator: Placebo Active Comparator: Montelukast 10mg

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	245
Estimated Completion Date	May 2011
Estimated Primary Completion Date	May 2011
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 ≤ 85% 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 or history of drug or alcohol abuse 7. Inhaled, oral or parenteral corticosteroids within 4 weeks before visit 1 8. Change of Immunotherapy within 6 months before visit 1 9. Administration of the antiasthma agent within 1 week of visit 1 10. Administration of any other medication which may affect the course of asthma, or interact with sympathomimetic amines 11. Participation in study using an experimental medication within 1 month before visit 1 12. Other ineligible subject in the opinion of the investigator
Gender	Both
Ages	15 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Korea, Republic of

Administrative Information[ + expand ][ + ]

NCT Number	NCT00936624
Other Study ID Numbers	SOTB07_AST_II_2008
Has Data Monitoring Committee	Yes
Information Provided By	SK Chemicals Co.,Ltd.
Study Sponsor	SK Chemicals Co.,Ltd.
Collaborators	Not Provided
Investigators	Principal Investigator: Sangheon Cho, professor Seoul National University Hospital
Verification Date	December 2013

Locations[ + expand ][ + ]