Study Phase III Study to Assess the Efficacy and Safety of SOTB07 in Asthma Patients

NCT ID: NCT01907763

Last Updated: 2016-01-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 194 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31

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

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SOTB07 200mg

One tablet of SOTB07 200mg and One tablet of SOTB 400mg Placebo are administered twice a day.

Group Type: EXPERIMENTAL

SOTB07 200mg

Intervention Type: DRUG

SOTB 400mg placebo

Intervention Type: DRUG

Placebo of SOTB07 400mg

SOTB07 400mg

One tablet of SOTB07 400mg and One tablet of SOTB 200mg Placebo are administered twice a day.

Group Type: EXPERIMENTAL

SOTB07 400mg

Intervention Type: DRUG

SOTB 200mg placebo

Intervention Type: DRUG

Placebo of SOTB07 200mg

Placebo

One tablet of SOTB 200mg Placebo and One tablet of SOTB 400mg Placebo are administered twice a day.

Group Type: PLACEBO_COMPARATOR

SOTB 200mg placebo

Intervention Type: DRUG

Placebo of SOTB07 200mg

SOTB 400mg placebo

Intervention Type: DRUG

Placebo of SOTB07 400mg

Interventions

SOTB07 200mg

Intervention Type: DRUG

SOTB07 400mg

Intervention Type: DRUG

SOTB 200mg placebo

Placebo of SOTB07 200mg

Intervention Type: DRUG

SOTB 400mg placebo

Placebo of SOTB07 400mg

Intervention Type: DRUG

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

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SK Chemicals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sangheon Cho, professor

Role: STUDY_CHAIR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

SOTB07_AST_III_2012

Identifier Type: -

Identifier Source: org_study_id