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

A 12-week, Multi-center, Randomized, Double Blinded, Parallel Group, Placebo-controlled Study to Assess the Efficacy and Safety of SOTB07 in Asthma Patients

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.

Study Overview

• Status: Terminated
• Conditions: Asthma
• Intervention / Treatment: Drug: SOTB07 200mg; Drug: SOTB 400mg placebo; Drug: SOTB07 400mg; Drug: SOTB 200mg placebo

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

• Study Type: Interventional
• Enrollment (Actual): 194
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SOTB07 200mg; One tablet of SOTB07 200mg and One tablet of SOTB 400mg Placebo are administered twice a day.	Drug: SOTB07 200mg; Drug: SOTB 400mg placebo; Placebo of SOTB07 400mg
Experimental: SOTB07 400mg; One tablet of SOTB07 400mg and One tablet of SOTB 200mg Placebo are administered twice a day.	Drug: SOTB07 400mg; Drug: SOTB 200mg placebo; Placebo of SOTB07 200mg
Placebo Comparator: Placebo; One tablet of SOTB 200mg Placebo and One tablet of SOTB 400mg Placebo are administered twice a day.	Drug: SOTB 400mg placebo; Placebo of SOTB07 400mg; Drug: SOTB 200mg placebo; Placebo of SOTB07 200mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
FEV1 change from the baseline	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in spirometer parameters		12 weeks
Change in FeNO		12 weeks
Change in AM/PM PEFR		12 weeks
Change in diurnal asthma symptom score		12 weeks
Change in the number of days with experience of nocturnal asthma symptoms		12 weeks
Change in amount of beta-2 agonist used (puff/day)		12 weeks
Proportion of rescue free day		12 weeks
Proportion of asthma control day		12 weeks
Proportion of asthma exacerbation		12 weeks
Proportion of treatment failure (severe asthma exacerbation)		12 weeks
Changes in asthma control questionaire score		12 weeks
Changes in quality of life questionaire for adult korea asthmatics scores		12 weeks
Changes in patient's global self assessment score		12 weeks
Change in visual analogue scale for cough score		12 weeks
Change in biomarkers (eosinophil, neutrophil, ECP, eotaxin) in blood sample		12 weeks
Change in biomarkers (eosinophil, neutrophil, ECP, eotaxin) in sputum sample		12 weeks
Assessment of Safety	Adverse Event/ Vital Sign/ Laboratory Test	12 weeks

Collaborators and Investigators

• Sponsor: SK Chemicals Co., Ltd.
• Investigators: Study Chair: Sangheon Cho, professor, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: July 17, 2013
• First Submitted That Met QC Criteria: July 22, 2013
• First Posted (Estimate): July 25, 2013

Study Record Updates

• Last Update Posted (Estimate): January 28, 2016
• Last Update Submitted That Met QC Criteria: January 26, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: asthma; SOTB07
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: SOTB07_AST_III_2012