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

SK chemicals

Status and phase: Terminated; Phase 3

Conditions: Asthma

Treatments: Drug: SOTB07 200mg; Drug: SOTB 200mg placebo; Drug: SOTB 400mg placebo; Drug: SOTB07 400mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01907763

SOTB07_AST_III_2012

Details and patient eligibility

About

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.

Full 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

Enrollment: 194 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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194 participants in 3 patient groups, including a placebo group

SOTB07 200mg

Experimental group

Description:

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

Treatment:

Drug: SOTB 400mg placebo

Drug: SOTB07 200mg

SOTB07 400mg

Experimental group

Description:

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

Treatment:

Drug: SOTB 200mg placebo

Drug: SOTB07 400mg

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: SOTB 400mg placebo

Drug: SOTB 200mg placebo