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

Phase 3

Terminated

• Conditions: Asthma
• Interventions: Drug: SOTB07 400mg; Drug: SOTB 200mg placebo; Drug: SOTB07 200mg; Drug: SOTB 400mg placebo

• Registration Number: NCT01907763
• Lead Sponsor: SK Chemicals Co., Ltd.

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

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-07-17
• Study First Submitted QC: 2013-07-22
• Study First Posted: 2013-07-25
• Primary Completion: 2015-10
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-26
• Last Update Posted: 2016-01-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 194

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
FEV1 change from the baseline	12 weeks

Secondary Outcome Measures

Name	Time	Method
Change in diurnal asthma symptom score	12 weeks
Change in amount of beta-2 agonist used (puff/day)	12 weeks
Proportion of asthma exacerbation	12 weeks
Change in biomarkers (eosinophil, neutrophil, ECP, eotaxin) in sputum sample	12 weeks
Change in spirometer parameters	12 weeks
Change in AM/PM PEFR	12 weeks
Change in the number of days with experience of nocturnal asthma symptoms	12 weeks
Proportion of asthma control day	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 FeNO	12 weeks
Proportion of rescue free day	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
Proportion of treatment failure (severe asthma exacerbation)	12 weeks
Changes in asthma control questionaire score	12 weeks
Assessment of Safety	12 weeks	Adverse Event/ Vital Sign/ Laboratory Test

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of