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

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

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

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: placebo; Drug: SOTB07; Drug: SOTB07; Drug: montelukast

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 245
• Phase: Phase 2

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 ≤ 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 β2-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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: placebo; placebo
Experimental: SOTB07 100mg	Drug: SOTB07; SOTB07 100mg; Drug: SOTB07; SOTB07 200mg
Experimental: SOTB07 200mg	Drug: SOTB07; SOTB07 100mg; Drug: SOTB07; SOTB07 200mg
Active Comparator: Montelukast 10mg	Drug: montelukast; montelukast 10mg po, bid, 12week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
% change from baseline for FEV1 at each visit	12 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: July 8, 2009
• First Submitted That Met QC Criteria: July 9, 2009
• First Posted (Estimate): July 10, 2009

Study Record Updates

• Last Update Posted (Estimate): December 19, 2013
• Last Update Submitted That Met QC Criteria: December 17, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Persistent asthma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Montelukast
• Other Study ID Numbers: SOTB07_AST_II_2008