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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00936624
• Other study ID #: SOTB07_AST_II_2008
• Status: Completed
• Phase: Phase 2
• First received: July 8, 2009
• Last updated: December 17, 2013
• Start date: July 2009
• Est. completion date: May 2011

Study information

• Verified date: December 2013
• Source: SK Chemicals Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is a dose finding trial to assess the efficacy and safety of SOTB07 in persistent asthma.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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 ß2-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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• SOTB07
SOTB07 100mg
• SOTB07
SOTB07 200mg
• placebo
placebo
• montelukast
montelukast 10mg po, bid, 12week

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
SK Chemicals Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% change from baseline for FEV1 at each visit		12 weeks	Yes